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

GCS Ramsay Santé pour l'Enseignement et la Recherche

Status: Completed

Conditions: Colectomy

Treatments: Drug: anaesthesia without opiates; Drug: anaesthesia with morphine

Study type: Interventional

Funder types: Other

Identifiers

NCT05031234

2020-A02585-34

Details and patient eligibility

About

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

Full 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

Enrollment: 160 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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160 participants in 2 patient groups

Group with morphine

Active Comparator group

Description:

conventional general anaesthesia with morphine

Treatment:

Drug: anaesthesia with morphine

Group without opiates

Experimental group

Description:

general anaesthesia without opiates

Treatment:

Drug: anaesthesia without opiates