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CompletedNCT03776838NOLGYNUpdated Oct 4, 2021

Impact of Nociceptive-Level (NOL) Intraoperative Guided Analgesia During Gynecological Laparoscopic Surgery Under General Anesthesia

A Phase 4 interventional study of Intravenous Fentanyl guided by SoC+NOL and Intravenous Fentanyl guided by SoC in Gynecologic Laparoscopic Surgery, Hysterectomy and Oophorectomy, sponsored by Ciusss de L'Est de l'Île de Montréal. Completed at 1 site in Canada. Open to female participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2021-10-04.

Sponsored by Ciusss de L'Est de l'Île de Montréal · Phase 4, Interventional, and Prevention

Phase
Phase 4
Study type
Interventional
Enrollment
70
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
Female
01

Study summary

The aim of the present study is to show that the use of the NOL device in addition to the Standard of Care (based on mean arterial blood pressure and heart rate values) to guide the administration of opioids compared to the Standard of Care reduces the total fentanyl consumption and the number of intraoperative administration of IV fentanyl during gynecological laparoscopic surgery and improves postoperative outcomes in PACU.

Read the detailed description

Hypothesis: We hypothesize that the group who will be administered intraoperative fentanyl based on NOL + mean arterial blood pressure (MABP) + heart rate (HR) values (SoC+NOL group) versus on MABP and HR (SoC group) will need less intra and postoperative opioid and will report less postoperative pain which will be reflected by a reduced number of adverse effects associated with opioid and/or reduced postoperative pain scores at the PACU arrival resulting in a faster time of readiness to discharge.

Background: The NOL index, a nociception monitor using a multiparametric approach, has shown an excellent sensitivity and specificity in detecting noxious stimuli under general anesthesia. This monitor is better than any other classically used clinical parameter in grading nociception under general anesthesia. More recently, a strong correlation between NOL index response to nociceptive stimulus and the level of opioid analgesia during surgery was reported. Studies are now conducted in our center (Maisonneuve-Rosemont Hospital, University of Montreal, Montreal, QC, Canada) to show a better post-operative outcome when using intraoperative NOL monitoring to adapt nociception/anti-nociception balance during general anesthesia (GA) for colorectal surgery.

So far, no study has evaluated in gynecological laparoscopic surgery the impact of NOL monitoring to guide the administration of intraoperative IV fentanyl on intra and postoperative opioid consumption and pain scores.

Objectives: Primary objective:

Reduction in total intraoperative fentanyl consumption (in mcg) and number of intraoperative administrations of IV fentanyl in the SoC+NOL analgesia guided versus SoC analgesia guided group (SoC = Standard of Care).

Secondary objectives:

Secondary outcome [1] Post-operative opioid consumption (IV hydromorphone in PACU) until patient is ready for discharge from Post-Anesthesia Care Unit.

Secondary outcome [2] Post-operative pain scores at rest and at coughing recorded in PACU by using numerical pain rating scales (NRS) in PACU (evaluated Q15min for 1h).

Secondary outcome [3] Intraoperative total consumption and frequency of administration of vasoactive drugs.

Secondary outcome [4] Post-operative sedation scores with Ramsay Sedation Score recorded every 15 minutes in PACU for at least 1h Secondary outcome [5]

Post-operative side-effects within 24 hours post-operatively:

  1. Nausea and vomiting: measure of the incidence of any nausea, emetic episodes (retching or vomiting), or both (i.e. postoperative nausea and vomiting) during the first 24 postoperative hours. Upon Discharge from PACU, and at 24 hours post-surgery, patients will verbally rate their worst nausea episode since emergence on an 11-point scale, where 0 represented no nausea and 10 the most severe nausea.
  2. Respiratory depression: defined as respiratory rate (RR) below 9 respirations per minutes (RPM). Respiratory rate will be recorded at 5-minute intervals, manually or per PACU monitor. The incidence of RR \< 9 RPM during the first 1.5 hours since admission to PACU will be recorded, as well as requirement for naloxone reversal of opioids or additional reversal of muscle relaxants.
  3. Itching: score of itching recorded every 10-15 minutes on an 11-point scale, where 0 is no itching and 11 is the most severe itching possible.

Secondary outcome [6] Post-operative time to discharge from PACU.

This time will be recorded since it may be different from the actual time of discharge which may be prolonged due to non-medical reasons. Patient discharge will be based upon a or b whichever comes first:

  1. Time of readiness to discharge from PACU, based on the evaluation of the Aldrete score (out of 9 points) and patient pain level (HMR local score, out of 16 points).
  2. Time of discharge from PACU. Secondary outcome [7] Time to first postoperative pain rescue medication administration in PACU or on wards.

Methods: Enrollment of 70 randomized adult patients undergoing general anesthesia for gynecological laparoscopic surgery (e.g. hysterectomy, uni- or bilateral Oophorectomy), which will be randomized to 2 groups: SoC guided analgesia (control group) versus SoC+NoL guided analgesia (intervention group).

All patients will be consented prior to the surgery. Anesthesia will be standardized for all patients, with: IV lidocaine (0.5mg.kg-1), Propofol (2mg.kg-1), IV fentanyl (2mcg.kg-1), IV rocuronium (0.6mg.kg-1). Depth of anesthesia with sevoflurane will be maintained and monitored with the BIS index kept between 40 and 60. In both the groups, rocuronium will be administered to keep the response to the train of four below 2/4 (TOFScan, Draeger). IV fentanyl will be intraoperatively administered based on HR and MABP variations on the SOC group and HR + MABP + NOL index in the NOL group (see attached decision algorithm). At the end of surgery, all patients will be extubated in the OR, then transferred to PACU. In PACU pain scores and recovery scores (PONV, sedation, respiratory depression, itching, delirium...) and hydromorphone requirements to reach a pain \< 3/10 will be assessed as well as Aldrete score and time for readiness for PACU discharge. The study will end at PACU discharge. This study will be registered on clinicaltrial.gov website.

Power calculation: Statistical analyses will be done using SAS version 9.4 or higher and will be performed at a two-sided 0.05 significance level. The primary objective of the study is reduced in total intraoperative fentanyl consumption (in mcg) and number of intraoperative administration of IV fentanyl in the SoC+NOL analgesia guided versus SoC analgesia guided group. Preliminary results from our center (HMR/CEMTL) showed that patients in SOC group had an IV intraoperative fentanyl consumption of 616 +/- 190 mcg during anesthesia. For an expected decrease of 25% in the SoC+NOL group for this PACU IV hydromorphone consumption, with a type I error α = 0.05 (two-tailed), an 90% power, the total sample size needed is 64. To account for an approximative 10% rate of loss to follow-up or missing data due to technical problems, a total of 70 subjects will be recruited. Because of the large number of secondary objectives and to protect against type I error in a less conservative way than the Bonferroni correction, the Holm step-down procedure will be applied to the sets of secondary hypotheses.

Significance/Importance: The main outcomes of this study will be to demonstrate that intraoperative NOL guidance decreases the need of intra- and post-operative opioids and might improve postoperative recovery after this type of gynecological surgery.

Study Design: This is a single-center, prospective, randomized, parallel-group, single-blinded.

Subject Population: Adult patients scheduled to undergo elective gynecological laparoscopic surgery (hysterectomy and uni- or bilateral oophorectomy) under general anesthesia.

Sample Size: 70 patients will be included in this study.

Study Duration: 12 months.

Study Center: Maisonneuve-Rosemont Hospital, CIUSSS de l'Est de l'Ile de Montreal (CEMTL), University of Montreal, Montreal, Quebec, Canada.

Adverse Events: None expected.

Subvention: An Independent Investigator Initiated Trial (IIIT) grant application will be sent to the company Medasense Biometrics LTD for the sponsoring of this study. A contract will be made and signed by both the parties: Medasense Biometrics LTD on one hand and the CR-HMR and the CEO of the CEMTL/HMR prior to starting the study.

02

Conditions studied

  • Gynecologic Laparoscopic Surgery
  • Hysterectomy
  • Oophorectomy

Keywords

  • NOL monitoring
  • anesthesia
  • fentanyl consumption
  • intraoperative
03

In context

Lead sponsor

Ciusss de L'Est de l'Île de Montréal is the lead sponsor of 87 studies on the registry; 32 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

  1. Female age 18-75 years
  2. ASA I-III
  3. adult patients scheduled to undergo elective gynecological laparoscopic surgery (hysterectomy and uni- or bilateral oophorectomy) under general anesthesia
  4. patient able to consent in the language of the including center

Exclusion criteria

Exclusion Criteria:

  1. use of any type of anesthesia other than general anesthesia (neuraxial, epidural analgesia or local regional anesthesia, e.g. transversus abdominal plane block...)
  2. patients with non-regular sinus cardiac rhythm, implanted pacemakers, prescirbed antimuscarinic agents, alpha2-adrenergic agonists, beta1-adrenergic antagonists, and antiarrhythmic agents
  3. emergent surgery
  4. pregnancy/lactation. Pregnancy test will be performed in all women of child bearing age
  5. BMI > 35 kg/m2
  6. preoperative hemodynamic disturbance
  7. central nervous system disorder (neurologic/ head trauma/ uncontrolled epileptic seizures)
  8. drug or alcohol abuse within the last 6 months (for women, > 3 drinks on one occasion or >7 drinks during a week)
  9. pre-operative chronic opioid use or chronic pain, equivalent to oxycodone 20mg per oral, per day for more than 6 weeks
  10. chronic use of psychoactive drugs within 90 days prior to surgery

  11. medical conditions qualifying for ASA III or IV:

    1. untreated or persistent peripheral or central cardiovascular disease
    2. severe pulmonary disease e.g. COPD gold 4, FEV\< 1.0l/s, or (evidence of) elevated paCO2 > 6.0 kPa
    3. significant hepatic disease with increased bilirubin, INR or low albumin
    4. history of severe cardiac arrhythmia e.g. chronic atrial fibrillation
    5. active pacemaker or defibrillator
  12. allergy or intolerance to any of the study drugs
  13. intraoperative cardiac arrhythmia
05

Study design

Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Outcomes assessor)
Enrollment
70 participants (actual)

Study arms

  • Experimental
    SoC+NOL analgesia guided fentanyl administration

    A bolus of 2 mcg/kg of IV Fentanyl will be given at the induction of the anesthesia. A bolus of 1 mcg/kg of IV Fentanyl will be given at the time of incision. During surgery, administration of 0.5 mcg/kg of IV Fentanyl will be administered following a pre determinate algorithm based on NOL index + heart rate + mean arterial blood pressure variations. Intervention is NOL monitoring in this group that will help to guide intravenous administration of fentanyl during surgery.

    Drug: Intravenous Fentanyl guided by SoC+NOL

  • Active comparator
    SoC analgesia guided group

    A bolus of IV Fentanyl at the discretion of a physician will be given at the induction of the anesthesia. A bolus of IV Fentanyl at the discretion of a physician will be given at the time of incision. During surgery, administration of IV Fentanyl at the discretion of a physician will be administred following a pre determinated algorithm based on heart rate + mean arterial blood pressure variations. Intervention will be here to use Heart rate and blood pressure to administer intraoperative intravenous fentanyl.

    Drug: Intravenous Fentanyl guided by SoC

Interventions

  • DrugIntravenous Fentanyl guided by SoC+NOL

    Predeterminated bolus of IV Fentanyl will be given at the induction of anesthesia (2 mcg/kg), at the time of incision (1 mcg/kg). During surgery, administration of 0.5 mcg/kg of IV Fentanyl will be administred following a pre determinated algorithm based on NOL index + heart rate + mean arterial blood pressure variations.

  • DrugIntravenous Fentanyl guided by SoC

    Bolus of IV Fentanyl at the discretion of a physician will be given at the induction of anesthesia, and at the time of incision. During surgery, administration of IV Fentanyl at the discretion of a physician will be administred following a pre determinated algorithm based on heart rate + mean arterial blood pressure variations.

06

What researchers measure

Primary outcomes

  1. Change of intraoperative IV fentanyl consumption in the Soc+NOL guided group compared to the SoC guided group. Total consumption of fentanyl in mcg.

    Change of intraoperative IV fentanyl consumption in the SoC+NOL guided group compared to the SoC guided group.

    Time frame: Intra-operative

  2. Change of frequency of intraoperative IV fentanyl administration in the Soc+NOL guided group compared to the SoC guided group. Frequency is in minutes

    Change of frequency of intraoperative IV fentanyl administration in the Soc+NOL guided group compared to the SoC guided group.

    Time frame: Intra-operative

Secondary outcomes

  1. Change of post-operative IV hydromorphone consumption. Total consumption of hydromorphone in mcg.

    Change of postoperative IV hydromorphone consumption in the SoC+NOL guided group compared to the SoC guided group in the post operative care unit (PACU).

    Time frame: PACU stay (1.5 hours)

  2. Assessment of post operative pain at rest at T0 minutes in PACU by using Numerical pain rating scales (NPRS) from 0 to 10

    Assessment of post operative pain at rest at T0 minutes in PACU by using Numerical pain rating scales (NPRS). Score is from 0 to 10.

    Time frame: PACU entrance

  3. Assessment of post operative pain at rest at T15 minutes in PACU by using Numerical pain rating scales (NPRS) from 0 to 10

    Assessment of post operative pain at rest at T15 minutes in PACU by using Numerical pain rating scales (NPRS). Score is from 0 to 10.

    Time frame: 15 min after PACU entrance

  4. Assessment of post operative pain at rest at T30 minutes in PACU by using Numerical pain rating scales (NPRS) from 0 to 10

    Assessment of post operative pain at rest at T30 minutes in PACU by using Numerical pain rating scales (NPRS). Score is from 0 to 10.

    Time frame: 30 min after PACU entrance

  5. Assessment of post operative pain at rest at T45 minutes in PACU by using Numerical pain rating scales (NPRS) from 0 to 10

    Assessment of post operative pain at rest at T45 minutes in PACU by using Numerical pain rating scales (NPRS). Score is from 0 to 10.

    Time frame: 45 min after PACU entrance

  6. Assessment of post operative pain at rest at T60 minutes in PACU by using Numerical pain rating scales (NPRS) from 0 to 10

    Assessment of post operative pain at rest at T60 minutes in PACU by using Numerical pain rating scales (NPRS). Score is from 0 to 10.

    Time frame: 60 min after PACU entrance

  7. Assessment of post operative pain at rest at T75 minutes in PACU by using Numerical pain rating scales (NPRS) from 0 to 10

    Assessment of post operative pain at rest at T75 minutes in PACU by using Numerical pain rating scales (NPRS). Score is from 0 to 10.

    Time frame: 75 min after PACU entrance

  8. Assessment of post operative pain at rest at T90 minutes in PACU by using Numerical pain rating scales (NPRS) from 0 to 10.

    Assessment of post operative pain at rest at T90 minutes in PACU by using Numerical pain rating scales (NPRS). Score is from 0 to 10.

    Time frame: 90 min after PACU entrance

  9. Assessment of post operative pain at coughing at T0 minutes in PACU by using Numerical pain rating scales (NPRS) from 0 to 10.

    Assessment of post operative pain at coughing at T0 minutes in PACU by using Numerical pain rating scales (NPRS). Score is from 0 to 10.

    Time frame: at PACU entrance

  10. Assessment of post operative pain at coughing at T15 minutes in PACU by using Numerical pain rating scales (NPRS) from 0 to 10.

    Assessment of post operative pain at coughing at T15 minutes in PACU by using Numerical pain rating scales (NPRS). Score is from 0 to 10.

    Time frame: 15 min after PACU entrance

  11. Assessment of post operative pain at coughing at T30 minutes in PACU by using Numerical pain rating scales (NPRS) from 0 to 10.

    Assessment of post operative pain at coughing at T30 minutes in PACU by using Numerical pain rating scales (NPRS). Score is from 0 to 10.

    Time frame: 30 min after PACU entrance

  12. Assessment of post operative pain at coughing at T45 minutes in PACU by using Numerical pain rating scales (NPRS) from 0 to 10.

    Assessment of post operative pain at coughing at T45 minutes in PACU by using Numerical pain rating scales (NPRS). Score is from 0 to 10.

    Time frame: 45 min after PACU entrance

  13. Assessment of post operative pain at coughing at T60 minutes in PACU by using Numerical pain rating scales (NPRS) from 0 to 10.

    Assessment of post operative pain at coughing at T60 minutes in PACU by using Numerical pain rating scales (NPRS). Score is from 0 to 10.

    Time frame: 60 min after PACU entrance

  14. Assessment of post operative pain at coughing at T75 minutes in PACU by using Numerical pain rating scales (NPRS) from 0 to 10.

    Assessment of post operative pain at coughing at T75 minutes in PACU by using Numerical pain rating scales (NPRS). Score is from 0 to 10.

    Time frame: 75 min after PACU entrance

  15. Assessment of post operative pain at coughing at T90 minutes in PACU by using Numerical pain rating scales (NPRS) from 0 to 10.

    Assessment of post operative pain at coughing at T90 minutes in PACU by using Numerical pain rating scales (NPRS). Score is from 0 to 10.

    Time frame: 90 min after PACU entrance

  16. Evaluation of intraoperative total vasoactive drugs (phenylephrine) consumption in mcg.

    Evaluation of intraoperative total phenylephrine consumption (in mcg)

    Time frame: During anesthesia for surgery

  17. Evaluation of intraoperative total vasoactive drugs (ephedrine) consumption in mcg

    Evaluation of intraoperative total ephedrine consumption (in mg)

    Time frame: During anesthesia for surgery

  18. Evaluation of intraoperative total vasoactive drugs (diltiazem) consumption in mg

    Evaluation of intraoperative total diltiazem consumption (in mg)

    Time frame: During anesthesia for surgery

  19. Evaluation of intraoperative frequency of vasoactive drugs (phenylephrine) administration in number of events

    Evaluation of intraoperative frequency of phenylephrine consumption (n)

    Time frame: During anesthesia for surgery

  20. Evaluation of intraoperative frequency of vasoactive drugs (ephedrine) administration in number of events

    Evaluation of intraoperative frequency of ephedrine consumption (n)

    Time frame: During anesthesia for surgery

  21. Evaluation of intraoperative frequency of vasoactive drugs (diltiazem) administration in number of events

    Evaluation of intraoperative frequency of diltiazem consumption (n)

    Time frame: During anesthesia for surgery

  22. Assessment of post operative sedation at T0 minutes in PACU by using Ramsay Sedation Score from 1 to 6

    Assessment of post operative sedation at T0 minutes in PACU by using Ramsay Sedation Score. Score is from 1 to 6.

    Time frame: at PACU entrance

  23. Assessment of post operative sedation at T15 minutes in PACU by using Ramsay Sedation Score from 1 to 6

    Assessment of post operative sedation at T15 minutes in PACU by using Ramsay Sedation Score. Score is from 1 to 6.

    Time frame: 15 min after PACU entrance

  24. Assessment of post operative sedation at T30 minutes in PACU by using Ramsay Sedation Score from 1 to 6

    Assessment of post operative sedation at T30 minutes in PACU by using Ramsay Sedation Score. Score is from 1 to 6.

    Time frame: 30 min after PACU entrance

  25. Assessment of post operative sedation at T45 minutes in PACU by using Ramsay Sedation Score from 1 to 6

    Assessment of post operative sedation at T45 minutes in PACU by using Ramsay Sedation Score. Score is from 1 to 6.

    Time frame: 45 min after PACU entrance

  26. Assessment of post operative sedation at T60 minutes in PACU by using Ramsay Sedation Score from 1 to 6

    Assessment of post operative sedation at T60 minutes in PACU by using Ramsay Sedation Score. Score is from 1 to 6.

    Time frame: 60 min after PACU entrance

  27. Assessment of post operative sedation at T75 minutes in PACU by using Ramsay Sedation Score from 1 to 6

    Assessment of post operative sedation at T75 minutes in PACU by using Ramsay Sedation Score. Score is from 1 to 6.

    Time frame: 75 min after PACU entrance

  28. Assessment of post operative sedation at T90 minutes in PACU by using Ramsay Sedation Score from 1 to 6

    Assessment of post operative sedation at T90 minutes in PACU by using Ramsay Sedation Score. Score is from 1 to 6.

    Time frame: 90 min after PACU entrance

  29. Number of nausea episodes in the 24 hours upon discharge from PACU

    To record the number of nausea episodes in the he 24 hours upon discharge from PACU (n)

    Time frame: The 24 hours upon discharge from PACU

  30. Number of emetic episodes in the 24 hours upon discharge from PACU

    To record the number of emetic episodes (retching or vomiting) in the he 24 hours upon discharge from PACU (n)

    Time frame: The 24 hours upon discharge from PACU

  31. Number of nausea AND vomiting episodes in the 24 hours upon discharge from PACU

    To record the number of nausea AND vomiting episodes in the he 24 hours upon discharge from PACU (n)

    Time frame: The 24 hours upon discharge from PACU

  32. Patient self evaluation of nausea intensity

    Patient verbal rate of their worst nausea episode since emergence using a 11 points scale (0: no nausea to 10: most severe nausea)

    Time frame: The 24 hours upon emergence

  33. Incidence of respiratory depression episodes

    Incidence of respiratory rate \< 9 respirations per minute episodes the first 1.5 hour since the admission to PACU (n)

    Time frame: 1.5 hour since the admission to PACU

  34. Incidence of requirement for naloxone reversal of opioids

    Incidence of requirement for naloxone reversal of opioids the first 1.5 hour since the admission to PACU (n)

    Time frame: 1.5 hour since the admission to PACU

  35. Incidence of requirement for additional reversal of muscle relaxants

    Incidence of requirement for additional reversal of muscle relaxants the first 1.5 hour since the admission to PACU (n)

    Time frame: 1.5 hour since the admission to PACU

  36. Assessment of post operative itching at T0 minutes in PACU from 0 to 10

    Assessment of post operative itching at T0 minutes in PACU by using a 11 points scale (0: no itching, to 10: the most severe itching possible)

    Time frame: At PACU entrance

  37. Assessment of post operative itching at T15 minutes in PACU from 0 to 10

    Assessment of post operative itching at T15 minutes in PACU by using a 11 points scale (0: no itching, to 10: the most severe itching possible)

    Time frame: 15 min after PACU entrance

  38. Assessment of post operative itching at T30 minutes in PACU from 0 to 10

    Assessment of post operative itching at T30 minutes in PACU by using a 11 points scale (0: no itching, to 10: the most severe itching possible)

    Time frame: 30 min after PACU entrance

  39. Assessment of post operative itching at T45 minutes in PACU from 0 to 10

    Assessment of post operative itching at T45 minutes in PACU by using a 11 points scale (0: no itching, to 10: the most severe itching possible)

    Time frame: 45 min after PACU entrance

  40. Assessment of post operative itching at T60 minutes in PACU from 0 to 10

    Assessment of post operative itching at T60 minutes in PACU by using a 11 points scale (0: no itching, to 10: the most severe itching possible)

    Time frame: 60 min after PACU entrance

  41. Assessment of post operative itching at T75 minutes in PACU from 0 to 10

    Assessment of post operative itching at T75 minutes in PACU by using a 11 points scale (0: no itching, to 10: the most severe itching possible)

    Time frame: 75 min after PACU entrance

  42. Assessment of post operative itching at T90 minutes in PACU from 0 to 10

    Assessment of post operative itching at T90 minutes in PACU by using a 11 points scale (0: no itching, to 10: the most severe itching possible)

    Time frame: 90 min after PACU entrance

  43. Post operative time to discharge from PACU in min

    To record the time since the admission to the discharge from PACU (min)

    Time frame: PACU stay (1.5 hours)

  44. Time to the first postoperative pain rescue medication administration in PACU in min

    To record the time since the admission in the PACU to the first postoperative pain rescue medication administration in PACU (min)

    Time frame: PACU stay (1.5 hours)

  45. Time to the first postoperative pain rescue medication administration after the PACU discharge

    To record the time since the discharge of PACU to the first postoperative pain rescue medication administration in PACU (min)

    Time frame: The 24 hours upon discharge from PACU

07

Study locations

1 site
  • Hopital Maisonneuve Rosemont, CIUSSS de l'Est de l'Ile de Montréal
    Montréal-Est, Quebec H1T2M4, Canada
08

References and documents

Publications

  • Morisson L, Nadeau-Vallee M, Espitalier F, Laferriere-Langlois P, Idrissi M, Lahrichi N, Gelinas C, Verdonck O, Richebe P. Prediction of acute postoperative pain based on intraoperative nociception level (NOL) index values: the impact of machine learning-based analysis. J Clin Monit Comput. 2023 Feb;37(1):337-344. doi: 10.1007/s10877-022-00897-z. Epub 2022 Aug 4. PubMed 35925430 ↗
  • Ghiyasinasab M, Morisson L, Laferriere-Langlois P, Geraldo-Demers MA, Gelinas C, Nadeau-Vallee M, Verdonck O, Lahrichi N, Richebe P. Identification of the intraoperative antinociceptive effect of intravenous fentanyl using the Nociception Level (NOL) index versus clinical parameters in patients undergoing gynecological laparoscopic surgery: A secondary analysis of the NOLGYN study. Anaesth Crit Care Pain Med. 2022 Aug;41(4):101102. doi: 10.1016/j.accpm.2022.101102. Epub 2022 May 25. PubMed 35643392 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 4, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03776838
Lead sponsor
Ciusss de L'Est de l'Île de Montréal
Collaborators
Medasense Biometrics Ltd
Responsible party
Philippe Richebe (MD PhD, Director of Research, Ciusss de L'Est de l'Île de Montréal) — Principal investigator
First posted
Dec 17, 2018
Start date
Nov 30, 2018
Primary completion
Dec 6, 2019
Completion
Sep 15, 2021
Last update
Oct 4, 2021

Study contacts

Philippe PR Richebé, MD PhD
principal investigator · CIUSSS Est de l'île de Montréal

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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