Clinical trial NCT05031234: Evaluation of the Benefit of Non-opioid General Anaesthesia on Postoperative Pain in Laparoscopic Colonic Surgery
Official title: Evaluation of the Benefit of Non-opioid General Anaesthesia on Postoperative Pain in Laparoscopic Colonic Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colectomy
Lead sponsor: GCS Ramsay Santé pour l'Enseignement et la Recherche
Sponsor class: OTHER
First posted: 2021-09-01
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Single-centre prospective randomised study carried out in two parallel groups of patients undergoing laparoscopic colectomy.

* Group 1: conventional general anaesthesia with morphine
* Group 2: general anaesthesia without opiates
Primary purpose: TREATMENT

Brief summary: Evaluation of the benefit of non-opioid general anaesthesia on postoperative pain in laparoscopic colonic surgery

Detailed description: Single-centre prospective randomised study carried out in two parallel groups of patients undergoing laparoscopic colectomy.

* Group 1: conventional general anaesthesia with morphine
* Group 2: general anaesthesia without opiates

Eligibility criteria: Inclusion Criteria:

* Patient over 18 years of age who has read and signed the consent form for participation in the study
* Patient candidate for laparoscopic colectomy (planned or emergency) with possible conversion to laparotomy

Exclusion Criteria:

* Severe renal failure with baseline clearance\<30, hepatic failure with baseline PT\<40%, cardiac failure with LVEF\<20%.
* Patient under court protection, guardianship or curatorship
* Pregnant or breastfeeding patient
* Patient not affiliated to the French social security system
* Impossible to give the subject informed information and/or to give written informed consent: dementia, psychosis, disturbed consciousness, non-French speaking patient
* Contraindication to anaesthesia or to the administration of one of the products used in the anaesthesia protocol
* Patient participating in another interventional research or in a period of exclusion from a previous research

Primary outcomes:
measure: Morphine Use
timeFrame: 48 hours
Secondary outcomes:
measure: Postoperative pain H12
timeFrame: Hour 12
measure: Postoperative pain H24
timeFrame: Hour 24
measure: Postoperative pain H36
timeFrame: Hour 36
measure: Postoperative pain H48
timeFrame: Hour 48
measure: Postoperative pain D30
timeFrame: Day 30
measure: Mean arterial pressure
timeFrame: 48 hours
measure: Mean arterial pressure variability
timeFrame: 48 hours
measure: Duration of Mean arterial pressure <65
timeFrame: 48 hours
measure: Duration of Mean arterial pressure <55
timeFrame: 48 hours
measure: Average heart rate
timeFrame: 48 hours
measure: Heart rate variability
timeFrame: 48 hours
measure: Bradycardia duration < 50
timeFrame: 48 hours
measure: Atropine dose administered
timeFrame: 48 hours
measure: Ephedrine dose administered
timeFrame: 48 hours
measure: Noradrenaline dose administered
timeFrame: 48 hours
measure: Neosynephrine dose administered
timeFrame: 48 hours
measure: Urapidil dose
timeFrame: 48 hours
measure: Nicardipine dose
timeFrame: 48 hours
measure: Postoperative hypoxemia
timeFrame: 48 hours
measure: Consumption of non-morphine drug
timeFrame: Day 90
measure: Assessment of tolerance
timeFrame: Day 90
measure: Assessment of disability
timeFrame: Day 30
measure: Assessment of disability
timeFrame: Day 90
measure: Time to extubation, time to resumption of transit, time to onset of first gas, length of stay in ICU and total length of hospital stay
timeFrame: Day 90 at least
measure: Immediate postoperative hypoxemia
timeFrame: Day 1
measure: Oxygen requirement
timeFrame: Day 2
Other outcomes:
Locations:
city: Villeurbanne
country: France
facility: Hôpital Privé Médipôle
Study officials:
References: