Evaluation of the Benefit of Non-opioid General Anaesthesia on Postoperative Pain in Laparoscopic Colonic Surgery (AGORA)

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

Study Overview

• Status: Completed
• Conditions: Colectomy
• Intervention / Treatment: Drug: anaesthesia with morphine; Drug: anaesthesia without opiates

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

• Study Type: Interventional
• Enrollment (Actual): 160
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Villeurbanne, France, 69100
    • Hôpital Privé Médipôle

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group with morphine; conventional general anaesthesia with morphine	Drug: anaesthesia with morphine; anaesthesia with morphine for patients undergoing laparoscopic colectomy
Experimental: Group without opiates; general anaesthesia without opiates	Drug: anaesthesia without opiates; Anaesthesia without opiates for patients undergoing laparoscopic colectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Morphine Use	All intravenous and oral morphine consumed in the first 48 hours after surgery	48 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	Day 30
Mean arterial pressure	Mean arterial pressure (MAP) (mmHg)	48 hours
Mean arterial pressure variability	MAP variability in percentage	48 hours
Duration of Mean arterial pressure <65	Duration of Mean arterial pressure <65 mmHg (min)	48 hours
Duration of Mean arterial pressure <55	Duration of Mean arterial pressure <65 mmHg (min)	48 hours
Average heart rate	Average heart rate	48 hours
Heart rate variability	Heart rate variability in percentage	48 hours
Bradycardia duration < 50	Bradycardia duration < 50 (min)	48 hours
Atropine dose administered	Atropine dose administered (mg)	48 hours
Ephedrine dose administered	Ephedrine dose administered (mg)	48 hours
Noradrenaline dose administered	Noradrenaline dose administered (ug)	48 hours
Neosynephrine dose administered	Neosynephrine dose administered (ug)	48 hours
Urapidil dose	Urapidil dose (mg)	48 hours
Nicardipine dose	Nicardipine dose (mg)	48 hours
Postoperative hypoxemia	Postoperative hypoxemia (Yes/No)	48 hours
Consumption of non-morphine drug	Consumption of NSAIDs, nefopam, tramadol, ondansetron and other antiemetics	Day 90
Assessment of tolerance	All adverse events will be collected and compared between the 2 groups	Day 90
Assessment of disability	Assessment of disability with the World Health Organization Disability Assessment Schedule (WHODAS2.0)	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.	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	Day 90 at least
Immediate postoperative hypoxemia	Immediate postoperative hypoxemia	Day 1
Oxygen requirement	Oxygen requirement (yes/no at D0, D1, D2)	Day 2

Collaborators and Investigators

• Sponsor: GCS Ramsay Santé pour l'Enseignement et la Recherche

Study record dates

Study Major Dates

• Study Start (Actual): December 17, 2020
• Primary Completion (Actual): February 17, 2023
• Study Completion (Actual): February 17, 2023

Study Registration Dates

• First Submitted: August 16, 2021
• First Submitted That Met QC Criteria: August 26, 2021
• First Posted (Actual): September 1, 2021

Study Record Updates

• Last Update Posted (Actual): December 18, 2023
• Last Update Submitted That Met QC Criteria: December 15, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Opioid; Narcotics; Anesthetics; Morphine
• Other Study ID Numbers: 2020-A02585-34

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No