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

Colectomy Clinical Trial

— AGORA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05031234
• Other study ID #: 2020-A02585-34
• Status: Completed
• Phase: N/A
• Start date: December 17, 2020
• Est. completion date: February 17, 2023

Study information

• Verified date: December 2023
• Source: GCS Ramsay Santé pour l'Enseignement et la Recherche
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Est. completion date: February 17, 2023
• Est. primary completion date: February 17, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Colectomy
• Pain, Postoperative

Intervention

Drug:
• anaesthesia without opiates
Anaesthesia without opiates for patients undergoing laparoscopic colectomy
• anaesthesia with morphine
anaesthesia with morphine for patients undergoing laparoscopic colectomy

Locations

Country	Name	City	State
France	Hôpital Privé Médipôle	Villeurbanne

Sponsors (1)

Lead Sponsor	Collaborator
GCS Ramsay Santé pour l'Enseignement et la Recherche

Country where clinical trial is conducted

France, 

Outcome

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