Laparoscopic Colorectal SurgeriesPhase 4NCT03910998
Impact of Intraoperative Deep Neuromuscular Blockade on NOL-guided Opioid Requirement in LSC Colorectal Surgeries
A Phase 4 study testing Rocuronium IV bolus 0.1 mg/kg guided by TOF that must remain between 1-3 during surgery and Rocuronium IV bolus 0.1 mg/kg guided by TOF 0/4 and PTC≤ 2 in people with Laparoscopic Colorectal Surgeries, run by Ciusss de L'Est de l'Île de Montréal at 1 site in Canada.
Trial summary
The aim of the present study is to answer the question whether deep neuromuscular blockade has a clinically significant impact on intra and postoperative pain, opioid requirement and anesthesia related outcomes and side effects for the early phase of recovery (24hs) after colorectal laparoscopic surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Laparoscopic Colorectal Surgeries
- What is being tested?
- Rocuronium IV bolus 0.1 mg/kg guided by TOF that must remain between 1-3 during surgery and Rocuronium IV bolus 0.1 mg/kg guided by TOF 0/4 and PTC≤ 2
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteCanada
- Study dates
- 30 May 2019to 1 Jul 2022
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA1-3 patients,
- fully consented,
- primary colorectal laparoscopic surgery and no previous laparotomy for the last 5 years
- BMI < 35,
- Age > 18yo,
- no allergy to any of the medications used in this study.
Who cannot join
- history of coronary artery disease
- serious cardiac arrhythmia (including atrial fibrillation)
- history of substance abuse
- chronic use of psychotropic and/or opioid drugs
- use of drugs that act on the autonomic nervous system (including β-blockers)
- history of psychiatric diseases with the need of medication
- allergy to any drug used in the study protocol
- refusal of the patient for participation in the study
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Hopital Maisonneuve Rosemont, CIUSSS de l'Est de l'Ile de Montréal
Montreal East, Quebec, H1T2M4
Nadia NG Godin, RC and RN, 514-252-3400 ext. 3193, ngodin.hmr@ssss.gouv.qc.ca
Philippe PR Richebé, MD PhD, 514-252-3400 ext. 4620, philipperichebe@live.com
About this study
Official title: A Randomized Parallel Design Study to Compare the Impact of Intraoperative Deep Neuromuscular Blockade on Intraoperative NOL-guided Opioid Requirement and Postoperative Early Outcomes in Laparoscopic Colorectal Surgeries
The aim of the present study is to answer the question whether deep neuromuscular blockade has a clinically significant impact on intra and postoperative pain, opioid requirement and anesthesia related outcomes and side effects for the early phase of recovery (24hs) after colorectal laparoscopic surgery.
Read the detailed description
Background: For the last decade many studies have reported that intraoperative surgical and anesthesia conditions might have an impact of postoperative pain.
The most recent surgical literature agrees on the fact the IAP should remain under 15mmhg or even 12mmhg during the whole laparoscopic surgery, and many efforts to do so were developed in the most recent years. On the anesthesia side, deep neuromuscular block was associated with better postoperative recovery when looking at pain parameters such as pain scores and opioid requirements. Nevertheless, all these previous studies, even if recent, did not properly evaluate intraoperative pain and did not well control criteria used to guide the administration of intraoperative opioids, one of the main components of anesthesia. Also, lots of these studies did not properly evaluate or control the depth of hypnosis, another main component of anesthesia. Nowadays, new monitors with extremely better sensitivity and specificity are available for each of the anesthesia component. This might completely revisit the previous findings in the literature and offer much better-quality results. Maisonneuve-Rosemont Hospital in Montreal is a unique center that has invested in new monitors to evaluate each of these anesthesia component: BIS index for depth of hypnosis (BIS device, Covidien, Saint-Laurent, Canada), NOL index (PM-200TM device, Medasense LTD, Ramat Gan, Israel) for nociceptive evaluation (intra-operative pain assessment under general anesthesia), and TOF-scan (NMB monitor, Drager, Mississauga, Canada) for quantitative and 3D evaluation of the depth of muscle relaxation.
This study will answer the question whether deep neuromuscular blockade has a clinically significant impact on intra and postoperative pain, opioid requirement and anesthesia related outcomes and side effects for the early phase of recovery (24hs) after colorectal laparoscopic surgery.
This study will be conducted in a single center, and will be an open label, single blinded, randomized controlled study. Type of surgery: laparoscopic colorectal surgery with anesthesia time expected to last more than 120min in ASA 1-3 patients, fully consented for primary colorectal laparoscopic surgery.
The primary objective of the study: To compare total intra-operative remifentanil consumption during anesthesia for laparoscopic colorectal surgery between two groups: Group "D" for Deep muscle relaxation and group "M" for Moderate muscle relaxation. Secondary objectives are listed below. For an expected decrease of 25% in the remifentanil intraoperative consumption per hour of surgery (in mcg) of surgery, with a type I error α = 0.05 (two-tailed), a 90% power, the total sample size needed is 82 (41 per group). To account for an approximative 20% rate of loss to follow-up or missing data due to technical problems, a total of 100 subjects will be recruited.
Study Duration: 24 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 has been accepted by the company Merck (see letter attached) for the sponsoring of this study.
- Conditions
- Laparoscopic Colorectal Surgeries
- Being tested
- Rocuronium IV bolus 0.1 mg/kg guided by TOF that must remain between 1-3 during surgery, Rocuronium IV bolus 0.1 mg/kg guided by TOF 0/4 and PTC≤ 2
- Keywords
- neuromuscular blockade, NOL monitoring, opioid consumption, intraoperative, anesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rocuronium IV bolus 0.1 mg/kg guided by TOF that must remain between 1-3 during surgeryDrug
Bolus of rocuronium 0.1 mg/kg at the discretion of anesthetist to keep the TOF between 1-3 out of 4 during surgery
Rocuronium IV bolus 0.1 mg/kg guided by TOF 0/4 and PTC≤ 2Drug
Bolus of rocuronium 0.1 mg/kg IV will be given during surgery for a TOF 0/4 and a PTC ≤ 2 (parameters measured every 10 minutes).
| Study group | Role | What they receive |
|---|---|---|
| Group "M" for Moderate muscle relaxation, low doses rocuronium | Active comparator | A bolus of 0.4 mg/kg of IV rocuronium will be given at the induction of the anesthesia.
Rocuronium IV bolus guided by TOF that must remain between 1-3 / 4 during surgery. Receives: Drug: Rocuronium IV bolus 0.1 mg/kg guided by TOF that must remain between 1-3 during surgery |
| Group "D" for Deep muscle relaxation, high doses rocuronium | Experimental | A bolus of 0.4 mg/kg of IV rocuronium will be given at the induction of the anesthesia.
Bolus of rocuronium 0.1 mg/kg IV will be given during surgery to keep the TOF 0/4 and a PTC ≤ 2 (parameters measured every 10 minutes). Receives: Drug: Rocuronium IV bolus 0.1 mg/kg guided by TOF 0/4 and PTC≤ 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total intra-operative remifentanil consumption during surgery in mcg/kg/h
To compare total intra-operative remifentanil consumption (in mcg per hour from T0 incision until Tend = start dressing) during anesthesia for laparoscopic colorectal surgery between two groups: Group "D" for Deep muscle relaxation and group "M" for Moderate muscle relaxation
Measured: Intra-operative (from T0 incision until Tend = start dressing)
Secondary outcomes (22)
Number of IV boluses and increases of remifentanil infusion, number, no unit
To compare the number of IV boluses and increases of remifentanil infusion needed in group D versus M
Measured: Intra-operative (from T0 incision until Tend = start dressing)
Number of times NOL index passes over the threshold of 25, number, no unit
To compare the number of times NOL index passes over the threshold of 25 (considered as painful threshold in an anesthetized patient) during anesthesia in group D versus M
Measured: Intra-operative (from T0 incision until Tend = start dressing)
Area Under the Curve (AUCs) whenever the NOL is above 25, no unit
To compare the Area Under the Curve (AUCs) of all the intraoperative periods for which the NOL index will be above the pain threshold of 25 from T0 until Tend
Measured: Intra-operative (from T0 incision until Tend = start dressing)
Total intraoperative time from T0 until Tend with NOL above 25 in minutes
To compare the total intraoperative time in minutes from T0 until Tend with NOL index above 25, with NOL index between 10 and 25, and with NOL index below 10 in group D versus M
Measured: Intra-operative (from T0 incision until Tend = start dressing)
Intraoperative level of intra-abdominal pressure (IAP) in mmHg
To compare between group D versus M the intraoperative level of intra-abdominal pressure (IAP) to keep a surgeons' satisfaction score (Leiden Surgical Rating Scale L-SRS)
Measured: Intra-operative (from T0 incision until Tend = start dressing)
Abdominal insufflation duration in minutes
To compare the time in minutes spent with abdominal insufflation and laparoscopic surgery between group D and M
Measured: Intra-operative (from T0 incision until Tend = start dressing)
Time for awakening and extubation in seconds
To compare the time for awakening and extubation (performed for all patients in the Operating Room, OR) between group D and M
Measured: Intra-operative (from T0 incision until Tend = start dressing)
Pain score at rest on a scale from 0 to 10
To compare maximal postoperative pain scores (Numeric Rating Scale, NRS) at: arrival in postanesthesia care unit (PACU), and every 15 min until PACU discharge at rest and coughing/mobilization
Measured: every 15 minutes until discharge from PACU, up to 3 hours
Pain score at coughing/mobilization on a scale from 0 to 10
To compare maximal postoperative pain scores (Numeric Rating Scale, NRS) at: arrival in postanesthesia care unit (PACU), and every 15 min until PACU discharge at rest and coughing/mobilization
Measured: every 15 minutes until discharge from PACU, up to 3 hours
Pain score at the shoulder on a scale from 0 to 10
To compare the incidence of shoulder pain and intensity (maximal NRS score at the shoulder) in PACU at arrival then every 15 minutes, between group D versus M
Measured: every 15 minutes until discharge from PACU, up to 3 hours
Postoperative Hydromorphone consumption in mg in Postoperative Care Unit (PACU)
To compare the total amount of hydromorphone (in mg) given IV in PACU as a pain killer titration following a strict PACU protocol to reach a NRS pain score < 4/10 between group D and M
Measured: every 15 minutes until discharge from PACU, up to 3 hours
Pain score at rest at 8hs on a scale from 0 to 10
To compare maximal postoperative pain scores at rest at 8 hours after surgery between group D and M
Measured: 8 hours after surgery in hospital
Pain score at coughing/mobilization at 8hs on a scale from 0 to 10
To compare maximal postoperative pain scores at coughing/movement at 8 hours after surgery between group D and M
Measured: 8 hours after surgery in hospital
Pain score at rest at 16hs on a scale from 0 to 10
To compare maximal postoperative pain scores at rest at 16 hours after surgery between group D and M
Measured: 16 hours after surgery in hospital
Pain score at coughing/mobilization at 16hs on a scale from 0 to 10
To compare maximal postoperative pain scores at coughing/movement at 16 hours after surgery between group D and M
Measured: 16 hours after surgery in hospital
Pain score at rest at 24hs on a scale from 0 to 10
To compare maximal postoperative pain scores at rest at 24 hours after surgery between group D and M
Measured: 24 hours after surgery in hospital
Pain score at coughing/mobilization at 24hs on a scale from 0 to 10
To compare maximal postoperative pain scores at coughing/movement every 24 hours after surgery between group D and M
Measured: 24 hours after surgery in hospital
Amount of opioids received in 24h as Patient Controlled Analgesia in mg
To compare analgesic requirements for 24 hours given as patient controlled analgesia (PCA) in mg over 24hs
Measured: 24 hours after surgery in hospital
Recovery score QOR15 questionnaire (150 points maximum for this questionnaire)
To compare recovery scores (QOR15) from 0 to 150 points at 24 hours after surgery
Measured: 24 hours after surgery in hospital
POSS postoperative Sedation score in PACU on a scale from 1 to 4
Sedation score in PACU
Measured: every 30 minutes from T0 = arrival in PACU until discharge from PACU, up to 3 hours
postoperative nausea and vomiting score in PACU on a scale from 0 to 3
nausea and vomiting score in PACU from 0 to 3
Measured: every 30 minutes from T0 = arrival in PACU until discharge from PACU, up to 3 hours
postoperative Aldrete score in PACU on a scale from 5 to 15
Recovery score in PACU to decide on the possibility of discharge of the patient from PACU
Measured: every 30 minutes from T0 = arrival in PACU until discharge from PACU, up to 3 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2019
- Study start30 May 2019
- Primary completion1 Jul 2022 (estimated)
- Study completion1 Jul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Laparoscopic Colorectal SurgeriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Tow groups of patients. Randomization into group "D" for Deep muscle relaxation vs group "M" for Moderate muscle relaxation according to a randomization list for a total number of 100 patients
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ciusss de L'Est de l'Île de Montréal
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Canada Inc.
- Responsible party
- Principal investigator, Philippe Richebe, Ciusss de L'Est de l'Île de Montréal
- Investigators
- Philippe PR Richebé, MD PhD, Principal investigator, CIUSSS Est de l'île de Montréal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03910998
- Sponsor's protocol ID
- 2019-1610
- Status last verified
- Apr 2022
- First submitted
- 4 Mar 2019
- Last updated
- 5 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Morisson L, Harkouk H, Othenin-Girard A, Oulehri W, Laferriere-Langlois P, Belanger ME, Idrissi M, Godin N, Verdonck O, Fortier LP, Poirier M, Henri M, Latulippe JF, Tremblay JF, Trepanier JS, Bendavid Y, Raft J, Richebe P. Impact of deep neuromuscular blockade on intraoperative NOL-guided remifentanil requirement during desflurane anesthesia in laparoscopic colorectal surgeries: A randomised controlled trial. J Clin Anesth. 2024 Dec;99:111659. doi: 10.1016/j.jclinane.2024.111659. Epub 2024 Oct 23.
PubMed 39447530
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Parallel Design Study to Compare the Impact of Intraoperative Deep Neuromuscular Blockade on Intraoperative NOL-guided Opioid Requirement and Postoperative Early Outcomes in Laparoscopic Colorectal Surgeries
- ClinicalTrials.gov ID
- NCT03910998
- Acronym / sponsor ID
- 2019-1610
- Conditions
- Laparoscopic Colorectal Surgeries
- Keywords
- neuromuscular blockade, NOL monitoring, opioid consumption, intraoperative, anesthesia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Ciusss de L'Est de l'Île de MontréalUniversity, hospital or other
- Collaborators
- Merck Canada Inc.
- Study start
- 30 May 2019 (actual)
- Primary completion
- 1 Jul 2022 (estimated)
- Study completion
- 1 Jul 2022 (estimated)
- First posted
- 10 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of the present study is to answer the question whether deep neuromuscular blockade has a clinically significant impact on intra and postoperative pain, opioid requirement and anesthesia related outcomes and side effects for the early phase of recovery (24hs) after colorectal laparoscopic surgery.
Detailed description
Background: For the last decade many studies have reported that intraoperative surgical and anesthesia conditions might have an impact of postoperative pain.
The most recent surgical literature agrees on the fact the IAP should remain under 15mmhg or even 12mmhg during the whole laparoscopic surgery, and many efforts to do so were developed in the most recent years. On the anesthesia side, deep neuromuscular block was associated with better postoperative recovery when looking at pain parameters such as pain scores and opioid requirements. Nevertheless, all these previous studies, even if recent, did not properly evaluate intraoperative pain and did not well control criteria used to guide the administration of intraoperative opioids, one of the main components of anesthesia. Also, lots of these studies did not properly evaluate or control the depth of hypnosis, another main component of anesthesia. Nowadays, new monitors with extremely better sensitivity and specificity are available for each of the anesthesia component. This might completely revisit the previous findings in the literature and offer much better-quality results. Maisonneuve-Rosemont Hospital in Montreal is a unique center that has invested in new monitors to evaluate each of these anesthesia component: BIS index for depth of hypnosis (BIS device, Covidien, Saint-Laurent, Canada), NOL index (PM-200TM device, Medasense LTD, Ramat Gan, Israel) for nociceptive evaluation (intra-operative pain assessment under general anesthesia), and TOF-scan (NMB monitor, Drager, Mississauga, Canada) for quantitative and 3D evaluation of the depth of muscle relaxation.
This study will answer the question whether deep neuromuscular blockade has a clinically significant impact on intra and postoperative pain, opioid requirement and anesthesia related outcomes and side effects for the early phase of recovery (24hs) after colorectal laparoscopic surgery.
This study will be conducted in a single center, and will be an open label, single blinded, randomized controlled study. Type of surgery: laparoscopic colorectal surgery with anesthesia time expected to last more than 120min in ASA 1-3 patients, fully consented for primary colorectal laparoscopic surgery.
The primary objective of the study: To compare total intra-operative remifentanil consumption during anesthesia for laparoscopic colorectal surgery between two groups: Group "D" for Deep muscle relaxation and group "M" for Moderate muscle relaxation. Secondary objectives are listed below. For an expected decrease of 25% in the remifentanil intraoperative consumption per hour of surgery (in mcg) of surgery, with a type I error α = 0.05 (two-tailed), a 90% power, the total sample size needed is 82 (41 per group). To account for an approximative 20% rate of loss to follow-up or missing data due to technical problems, a total of 100 subjects will be recruited.
Study Duration: 24 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 has been accepted by the company Merck (see letter attached) for the sponsoring of this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Tow groups of patients. Randomization into group "D" for Deep muscle relaxation vs group "M" for Moderate muscle relaxation according to a randomization list for a total number of 100 patients
| Arm | Type | Receives |
|---|---|---|
| Group "M" for Moderate muscle relaxation, low doses rocuronium | Active comparator | Drug: Rocuronium IV bolus 0.1 mg/kg guided by TOF that must remain between 1-3 during surgeryA bolus of 0.4 mg/kg of IV rocuronium will be given at the induction of the anesthesia. Rocuronium IV bolus guided by TOF that must remain between 1-3 / 4 during surgery. |
| Group "D" for Deep muscle relaxation, high doses rocuronium | Experimental | Drug: Rocuronium IV bolus 0.1 mg/kg guided by TOF 0/4 and PTC≤ 2A bolus of 0.4 mg/kg of IV rocuronium will be given at the induction of the anesthesia. Bolus of rocuronium 0.1 mg/kg IV will be given during surgery to keep the TOF 0/4 and a PTC ≤ 2 (parameters measured every 10 minutes). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- ASA1-3 patients,
- fully consented,
- primary colorectal laparoscopic surgery and no previous laparotomy for the last 5 years
- BMI < 35,
- Age > 18yo,
Key exclusion criteria (8 listed)
- history of coronary artery disease
- serious cardiac arrhythmia (including atrial fibrillation)
- history of substance abuse
- chronic use of psychotropic and/or opioid drugs
- use of drugs that act on the autonomic nervous system (including β-blockers)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rocuronium IV bolus 0.1 mg/kg guided by TOF that must remain between 1-3 during surgeryBolus of rocuronium 0.1 mg/kg at the discretion of anesthetist to keep the TOF between 1-3 out of 4 during surgery | Drug | Group "M" for Moderate muscle relaxation, low doses rocuronium |
| Rocuronium IV bolus 0.1 mg/kg guided by TOF 0/4 and PTC≤ 2Bolus of rocuronium 0.1 mg/kg IV will be given during surgery for a TOF 0/4 and a PTC ≤ 2 (parameters measured every 10 minutes). | Drug | Group "D" for Deep muscle relaxation, high doses rocuronium |
Primary outcome
Total intra-operative remifentanil consumption during surgery in mcg/kg/h
Time frame: Intra-operative (from T0 incision until Tend = start dressing)
To compare total intra-operative remifentanil consumption (in mcg per hour from T0 incision until Tend = start dressing) during anesthesia for laparoscopic colorectal surgery between two groups: Group "D" for Deep muscle relaxation and group "M" for Moderate muscle relaxation
22 secondary outcomes
Number of IV boluses and increases of remifentanil infusion, number, no unit
Time frame: Intra-operative (from T0 incision until Tend = start dressing)
Number of times NOL index passes over the threshold of 25, number, no unit
Time frame: Intra-operative (from T0 incision until Tend = start dressing)
Area Under the Curve (AUCs) whenever the NOL is above 25, no unit
Time frame: Intra-operative (from T0 incision until Tend = start dressing)
Total intraoperative time from T0 until Tend with NOL above 25 in minutes
Time frame: Intra-operative (from T0 incision until Tend = start dressing)
Intraoperative level of intra-abdominal pressure (IAP) in mmHg
Time frame: Intra-operative (from T0 incision until Tend = start dressing)
Abdominal insufflation duration in minutes
Time frame: Intra-operative (from T0 incision until Tend = start dressing)
Time for awakening and extubation in seconds
Time frame: Intra-operative (from T0 incision until Tend = start dressing)
Pain score at rest on a scale from 0 to 10
Time frame: every 15 minutes until discharge from PACU, up to 3 hours
Pain score at coughing/mobilization on a scale from 0 to 10
Time frame: every 15 minutes until discharge from PACU, up to 3 hours
Pain score at the shoulder on a scale from 0 to 10
Time frame: every 15 minutes until discharge from PACU, up to 3 hours
Postoperative Hydromorphone consumption in mg in Postoperative Care Unit (PACU)
Time frame: every 15 minutes until discharge from PACU, up to 3 hours
Pain score at rest at 8hs on a scale from 0 to 10
Time frame: 8 hours after surgery in hospital
Pain score at coughing/mobilization at 8hs on a scale from 0 to 10
Time frame: 8 hours after surgery in hospital
Pain score at rest at 16hs on a scale from 0 to 10
Time frame: 16 hours after surgery in hospital
Pain score at coughing/mobilization at 16hs on a scale from 0 to 10
Time frame: 16 hours after surgery in hospital
Pain score at rest at 24hs on a scale from 0 to 10
Time frame: 24 hours after surgery in hospital
Pain score at coughing/mobilization at 24hs on a scale from 0 to 10
Time frame: 24 hours after surgery in hospital
Amount of opioids received in 24h as Patient Controlled Analgesia in mg
Time frame: 24 hours after surgery in hospital
Recovery score QOR15 questionnaire (150 points maximum for this questionnaire)
Time frame: 24 hours after surgery in hospital
POSS postoperative Sedation score in PACU on a scale from 1 to 4
Time frame: every 30 minutes from T0 = arrival in PACU until discharge from PACU, up to 3 hours
postoperative nausea and vomiting score in PACU on a scale from 0 to 3
Time frame: every 30 minutes from T0 = arrival in PACU until discharge from PACU, up to 3 hours
postoperative Aldrete score in PACU on a scale from 5 to 15
Time frame: every 30 minutes from T0 = arrival in PACU until discharge from PACU, up to 3 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2022.
- Derived from this study: PubMed 39447530Morisson L, Harkouk H, Othenin-Girard A, Oulehri W, Laferriere-Langlois P, Belanger ME, Idrissi M, Godin N, Verdonck O, Fortier LP, Poirier M, Henri M, Latulippe JF, Tremblay JF, Trepanier JS, Bendavid Y, Raft J, Richebe P. Impact of deep neuromuscular blockade on intraoperative NOL-guided remifentanil requirement during desflurane anesthesia in laparoscopic colorectal surgeries: A randomised controlled trial. J Clin Anesth. 2024 Dec;99:111659. doi: 10.1016/j.jclinane.2024.111659. Epub 2024 Oct 23.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Philippe PR Richebé, MD PhD principal investigator
CIUSSS Est de l'île de Montréal
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Rocuronium IV bolus 0.1 mg/kg guided by TOF that must remain between 1-3 during surgery and Rocuronium IV bolus 0.1 mg/kg guided by TOF 0/4 and PTC≤ 2 in people with Laparoscopic Colorectal Surgeries, run by Ciusss de L'Est de l'Île de Montréal at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Philippe PR Richebé, MD PhD (514-743-6558, philippe.richebe@umontreal.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total intra-operative remifentanil consumption during surgery in mcg/kg/h (time frame: Intra-operative (from T0 incision until Tend = start dressing)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03910998, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Apr 2022.