A Phase 4 interventional study of Sugammadex and Rocuronium in Neuromuscular Block, sponsored by Centro Hospitalar do Porto. Completed at 1 site in Portugal. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2019-09-16.
Sponsored by Centro Hospitalar do Porto · Phase 4, Interventional, and Treatment
The investigators hypothesize that an anesthetic protocol maintaining deep neuromuscular block throughout the entire surgical procedure followed by sugammadex reversal, would suppress EMG activity and result in improved anesthetic stability by reducing the variability of the Bispectral Index of the EEG, and be beneficial by reducing the total doses of the anesthetic drugs propofol and remifentanil required to maintain an adequate level of anesthesia (BIS between 40 and 60).
Centro Hospitalar do Porto is the lead sponsor of 16 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Standard Clinical Practice Group - standard neuromuscular block, with a standard rocuronium dose for intubation (0.6 mg/kg). If required, the reversal of neuromuscular block is performed with neostigmine.
Deep Neuromuscular Block group - with a standard rocuronium dose for intubation (0.6 mg/kg), followed by a constant infusion of rocuronium (10-15 ug/kg/min) to guarantee a PTC less or equal to 2 on the TOF monitor (PTC is evaluated every 5 minutes). The reversal of neuromuscular block is performed with Sugammadex (4 mg/kg).
Drug: Sugammadex · Drug: Rocuronium
Reversal of deep neuromuscular block
Also known as: Org 25969, Bridion
Maintenance of deep neuromuscular block
Also known as: Zemuron, Esmeron
BIS Signal Variability Using the Measured Standard Deviation During the Maintenance Phase of Anesthesia
BIS (Bispetral Index of the EEG) sample standard deviation during the maintenance phase of anesthesia was used as a measure of signal variability, maintenance phase is defined as the time between the first time the BIS signal drops below 60 after loss of consciousness, until the time the BIS signal goes above 60 after the propofol infusion is stopped. BIS signal varies between 0 to 100. BIS values near 100 represent an "awake" clinical state while 0 denotes the maximal effect an isoelectric EEG. The aim was to maintain the BIS value within a target range of 40 to 60. The higher the BIS sample standard deviation the higher the oscillation around the sample mean.
Time frame: Maintenance of anesthesia, an average of 130 minutes
Required Effect-site Concentrations of Propofol and Remifentanil
Mean effect-site concentration of propofol required during maintenance of anesthesia (using target controlled infusion). Mean effect-site concentration of remifentanil required during maintenance of anesthesia (using target controlled infusion).
Time frame: Maintenance of anesthesia, an average of 130 minutes
PQRS Results at 15 and 40 Minutes After Surgery (Taking Into Account the Patient Baseline Values of the PQRS Test Done on the Preanesthetic Visit)
PQRS(Post-operative Quality Recovery Scale) recovery rate at 15 minutes post surgery and PQRS recovery rate at 40 minutes post surgery. Recovery is defined as returning to PQRS baseline values.
Time frame: 15 and 40 minutes after surgery
PQRS Satisfaction Results at Day 3 After Surgery
Patient satisfaction with anesthetic care rated as: Not satisfied, A little satisfied, Moderately satisfied ,Satisfied, Totally Satisfied
Time frame: 3rd day after surgery
Recruitment started on the 2016/9/19 and finished on 2017/6/28 at Centro Hospitalar do Porto, Portugal.
| Milestone | Standard Group | Deep NMB Group |
|---|---|---|
| Started | 35 | 35 |
| End of clinical study | 35 | 35 |
| Data analysis | 32 | 31 |
| Completed | 32 | 31 |
| Not completed | 3 | 4 |
| Withdrew: Patients' data files were corrupted. | 1 | 1 |
| Withdrew: Bis monitoring failed. | 1 | 1 |
| Withdrew: Time of the procedure less than 90 min. | 1 | 2 |
BIS (Bispetral Index of the EEG) sample standard deviation during the maintenance phase of anesthesia was used as a measure of signal variability, maintenance phase is defined as the time between the first time the BIS signal drops below 60 after loss of consciousness, until the time the BIS signal goes above 60 after the propofol infusion is stopped. BIS signal varies between 0 to 100. BIS values near 100 represent an "awake" clinical state while 0 denotes the maximal effect an isoelectric EEG. The aim was to maintain the BIS value within a target range of 40 to 60. The higher the BIS sample standard deviation the higher the oscillation around the sample mean.
| units on a scale | Standard Group | Deep NMB Group |
|---|---|---|
| BIS Signal Variability Using the Measured Standard Deviation During the Maintenance Phase of Anesthesia | 7.6 ± 1.6 | 7.8 ± 1.6 |
Mean effect-site concentration of propofol required during maintenance of anesthesia (using target controlled infusion). Mean effect-site concentration of remifentanil required during maintenance of anesthesia (using target controlled infusion).
| ng/ml | Standard Group | Deep NMB Group |
|---|---|---|
| Propofol | 3000 ± 560 | 2450 ± 550 |
| Remifentanil | 3.26 ± 1.02 | 2.84 ± 1.12 |
PQRS(Post-operative Quality Recovery Scale) recovery rate at 15 minutes post surgery and PQRS recovery rate at 40 minutes post surgery. Recovery is defined as returning to PQRS baseline values.
| Participants | Standard Group | Deep NMB Group |
|---|---|---|
| 15 minutes — Overall recovery | 2 | 5 |
| 15 minutes — Did not recovered | 24 | 21 |
| 40 minutes — Overall recovery | 0 | 3 |
| 40 minutes — Did not recovered | 32 | 27 |
Patient satisfaction with anesthetic care rated as: Not satisfied, A little satisfied, Moderately satisfied ,Satisfied, Totally Satisfied
| Participants | Standard Group | Deep NMB Group |
|---|---|---|
| Totally satisfied | 27 | 27 |
| Satisfied | 3 | 2 |
| Moderately satisfied | 0 | 0 |
| A little satisfied | 0 | 0 |
| Not satisfied | 0 | 0 |
Collected over Adverse event data were collected by the researchers up to 3 days after surgery.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Standard Group | 0/35 (0%) | 0/35 (0%) | 2/35 (5.7%) |
| Deep NMB Group | 0/35 (0%) | 0/35 (0%) | 6/35 (17.1%) |
| Event | Standard Group | Deep NMB Group |
|---|---|---|
| Emergence deliriumNervous system disorders | 0/35 | 2/35 |
| Neck painSurgical and medical procedures | 1/35 | 0/35 |
| Nausea and urinary retentionGeneral disorders | 1/35 | 0/35 |
| TachycardiaCardiac disorders | 0/35 | 1/35 |
| Post-operative hypertensionGeneral disorders | 0/35 | 1/35 |
| Asystole of 20 secondsCardiac disorders | 0/35 | 1/35 |
| Post-operative dyspnea and anxietySurgical and medical procedures | 0/35 | 1/35 |
| Age, Continuous(years) | Standard Group | Deep NMB Group | Total |
|---|---|---|---|
| Mean | 52.4 ± 10.7 | 52.6 ± 7.9 | 52.5 ± 9.3 |
| Sex: Female, Male(Participants) | Standard Group | Deep NMB Group | Total |
|---|---|---|---|
| Female | 18 | 17 | 35 |
| Male | 14 | 14 | 28 |
| Race (NIH/OMB)(Participants) | Standard Group | Deep NMB Group | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 |
| White | 32 | 31 | 63 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(Participants) | Standard Group | Deep NMB Group | Total |
|---|---|---|---|
| Portugal | 32 | 31 | 63 |
| Mean Arterial Pressure(mmHg) | Standard Group | Deep NMB Group | Total |
|---|---|---|---|
| Mean | 105.6 ± 12.8 | 101.4 ± 12.5 | 103.5 ± 12.7 |
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Centro Hospitalar do Porto