ClinicalTrials.gg
CompletedNCT05234697Updated Dec 28, 2022

Effect of Daytime Variation on Postoperative Hyperalgesia Induced by Opioids

An observational study in Postoperative Hyperalgesia, sponsored by The Second Affiliated Hospital of Chongqing Medical University. Completed at 1 site in China. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2022-12-28.

Sponsored by The Second Affiliated Hospital of Chongqing Medical University · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
60
Ages
18 Years to 65 Years
Sex
All
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Study summary

To explore the effect of daytime variation on postoperative hyperalgesia induced by opioids. Patients receiving endoscopy surgery under general anesthesia during 08:00-12:00(morning group, n=30) and 14:00-18:00(afternoon group, n=30) using remifentanil for anesthesia maintenance were respectively included. Postoperative hyperalgesia at PACU and 24 hours after surgery were assessed through mechanical pain measurement. Comparative analysis of postoperative hyperalgesia levels, pain and analgesic requirements between morning group and afternoon group were performed.

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Conditions studied

  • Postoperative Hyperalgesia

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03

In context

Hyperalgesia

166 studies on the registry are indexed under Hyperalgesia; 14 are open to participants now.

This study's enrollment of 60 is below the median of 87 across 18 observational studies indexed under Hyperalgesia.

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Lead sponsor

The Second Affiliated Hospital of Chongqing Medical University is the lead sponsor of 102 studies on the registry; 32 are open to participants now.

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

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Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients receiving endoscopy surgery under general anesthesia during 08:00-12:00(morning group, n=30) and 14:00-18:00(afternoon group, n=30) using remifentanil for anesthesia maintenance were included.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • classification I-II
  • Abdominal endoscopy surgery
  • Estimated surgery duration 1-2h
  • Right handedness
  • Voluntarily receive postoperative intravenous controlled analgesia

Exclusion criteria

Exclusion Criteria:

  • Heavy smoking or alcohol dependence
  • Puerpera or lactation women
  • History of chronic pain
  • Analgesic use within one month before surgery
  • Allergy to opioids
  • Can not follow with the study procedure
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

ASA physical status

The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.

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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
60 participants (actual)
Patient registry
No
Biospecimen retention
Samples without dna

Groups and cohorts

  • Morning group

    Surgery performed during 08:00 to 12:00

    Drug: Remifentanil

  • Afternoon group

    Surgery performed during 14:00 to 18:00

    Drug: Remifentanil

Interventions

  • Remifentanil was used for maintenance of anesthesia.

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What researchers measure

Primary outcomes

  1. Postoperative hyperalgesia when discharged from postanesthesia care unit

    The ratio of pressure pain threshold when discharged from PACU compare to before surgery

    Time frame: from the 30 minutes before the surgery until to the time when discharged from postanesthesia care unit, assessed up to about 2 hours

Secondary outcomes

  1. Postoperative hyperalgesia at 24 hours after surgery

    The ratio of pressure pain threshold at 24 hours after surgery compare to before surgery

    Time frame: from the 30 minutes before the surgery until to 24 hours after surgery

  2. Postoperative pain intensity

    Pain intensity was assessed by numerical rating scale (0-10, 0 represents painless; 10 represents intolerable pain)

    Time frame: from the time when the surgery was completed until to 24 hours after surgery

  3. Postoperative analgesic requirements

    Analgesic requirements was assessed by recording the volume of patient controlled analgesia pump

    Time frame: from the time when the surgery was completed until to 24 hours after surgery

  4. Plasma concentration of remifentanil and sufentanil

    Determined by Elisa test

    Time frame: from 30 minutes before the surgery until to the time after stop infusion of remifentanil, assessed up to about 2 hours

  5. Activity of plasma nonspecific esterase

    Determined by laboratory detection

    Time frame: from 30 minutes before the surgery until to the time after stop infusion of remifentanil, , assessed up to about 2 hours

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Study locations

1 site
  • Department of Anesthesiology, The Second Affiliated Hospital, Chongqing Medical University
    Chongqing, Chongqing 400010, China
08

References and documents

Individual participant data

Plan to share: Yes — The individual participant data for this study is available from the sponsor on reasonable request through email.

No publications or documents are linked to this record.

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Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Jan 2022 to primary completion in May 2022, 4 months.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 12, 2022
First posted
Feb 10, 2022
StartActual
Jan 12, 2022
Primary completionActual
May 20, 2022
CompletionActual
May 20, 2022
Last update
Dec 28, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Dec 28, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05234697
Responsible party
Sponsor
First posted
Feb 10, 2022
Start date
Jan 12, 2022
Primary completion
May 20, 2022
Completion
May 20, 2022
Last update
Dec 28, 2022

Oversight

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

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This study is completed, as verified in Dec 2022. You cannot join it, but the record below documents what was studied.

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