Evaluation of the benefit of non-opioid general anaesthesia on postoperative pain in laparoscopic colonic surgery
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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
160
Anaesthesia without opiates for patients undergoing laparoscopic colectomy
anaesthesia with morphine for patients undergoing laparoscopic colectomy
Hôpital Privé Médipôle
Villeurbanne, France
Morphine Use
All intravenous and oral morphine consumed in the first 48 hours after surgery
Time frame: 48 hours
Postoperative pain H12
Postoperative pain will be reported by the nursing staff on a simple numerical scale graduated from 0 to 10 after questioning the patient, according to the usual procedures of the department.
Time frame: Hour 12
Postoperative pain H24
Postoperative pain will be reported by the nursing staff on a simple numerical scale graduated from 0 to 10 after questioning the patient, according to the usual procedures of the department.
Time frame: Hour 24
Postoperative pain H36
Postoperative pain will be reported by the nursing staff on a simple numerical scale graduated from 0 to 10 after questioning the patient, according to the usual procedures of the department.
Time frame: Hour 36
Postoperative pain H48
Postoperative pain will be reported by the nursing staff on a simple numerical scale graduated from 0 to 10 after questioning the patient, according to the usual procedures of the department.
Time frame: Hour 48
Postoperative pain D30
Postoperative pain will be reported by the nursing staff on a simple numerical scale graduated from 0 to 10 after questioning the patient, according to the usual procedures of the department.
Time frame: Day 30
Mean arterial pressure
Mean arterial pressure (MAP) (mmHg)
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Time frame: 48 hours
Mean arterial pressure variability
MAP variability in percentage
Time frame: 48 hours
Duration of Mean arterial pressure <65
Duration of Mean arterial pressure \<65 mmHg (min)
Time frame: 48 hours
Duration of Mean arterial pressure <55
Duration of Mean arterial pressure \<65 mmHg (min)
Time frame: 48 hours
Average heart rate
Average heart rate
Time frame: 48 hours
Heart rate variability
Heart rate variability in percentage
Time frame: 48 hours
Bradycardia duration < 50
Bradycardia duration \< 50 (min)
Time frame: 48 hours
Atropine dose administered
Atropine dose administered (mg)
Time frame: 48 hours
Ephedrine dose administered
Ephedrine dose administered (mg)
Time frame: 48 hours
Noradrenaline dose administered
Noradrenaline dose administered (ug)
Time frame: 48 hours
Neosynephrine dose administered
Neosynephrine dose administered (ug)
Time frame: 48 hours
Urapidil dose
Urapidil dose (mg)
Time frame: 48 hours
Nicardipine dose
Nicardipine dose (mg)
Time frame: 48 hours
Postoperative hypoxemia
Postoperative hypoxemia (Yes/No)
Time frame: 48 hours
Consumption of non-morphine drug
Consumption of NSAIDs, nefopam, tramadol, ondansetron and other antiemetics
Time frame: Day 90
Assessment of tolerance
All adverse events will be collected and compared between the 2 groups
Time frame: Day 90
Assessment of disability
Assessment of disability with the World Health Organization Disability Assessment Schedule (WHODAS2.0)
Time frame: Day 30
Assessment of disability
Assessment of disability with the World Health Organization Disability Assessment Schedule (WHODAS2.0). Evolution between Day 30 and Day 90.
Time frame: Day 90
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
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
Time frame: Day 90 at least
Immediate postoperative hypoxemia
Immediate postoperative hypoxemia
Time frame: Day 1
Oxygen requirement
Oxygen requirement (yes/no at D0, D1, D2)
Time frame: Day 2