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

Primary Purpose

Colectomy

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
anaesthesia without opiates
anaesthesia with morphine
Sponsored by
GCS Ramsay Santé pour l'Enseignement et la Recherche
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colectomy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Hôpital Privé MédipôleRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Group with morphine

Group without opiates

Arm Description

conventional general anaesthesia with morphine

general anaesthesia without opiates

Outcomes

Primary Outcome Measures

Morphine Use
All intravenous and oral morphine consumed in the first 48 hours after surgery

Secondary Outcome Measures

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

Full Information

First Posted
August 16, 2021
Last Updated
August 26, 2021
Sponsor
GCS Ramsay Santé pour l'Enseignement et la Recherche
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1. Study Identification

Unique Protocol Identification Number
NCT05031234
Brief Title
Evaluation of the Benefit of Non-opioid General Anaesthesia on Postoperative Pain in Laparoscopic Colonic Surgery
Acronym
AGORA
Official Title
Evaluation of the Benefit of Non-opioid General Anaesthesia on Postoperative Pain in Laparoscopic Colonic Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Unknown status
Study Start Date
December 17, 2020 (Actual)
Primary Completion Date
January 2022 (Anticipated)
Study Completion Date
January 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GCS Ramsay Santé pour l'Enseignement et la Recherche

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colectomy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Masking
Participant
Masking Description
The patient does not know which treatment is used for the anesthesia
Allocation
Randomized
Enrollment
160 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group with morphine
Arm Type
Active Comparator
Arm Description
conventional general anaesthesia with morphine
Arm Title
Group without opiates
Arm Type
Experimental
Arm Description
general anaesthesia without opiates
Intervention Type
Drug
Intervention Name(s)
anaesthesia without opiates
Intervention Description
Anaesthesia without opiates for patients undergoing laparoscopic colectomy
Intervention Type
Drug
Intervention Name(s)
anaesthesia with morphine
Intervention Description
anaesthesia with morphine for patients undergoing laparoscopic colectomy
Primary Outcome Measure Information:
Title
Morphine Use
Description
All intravenous and oral morphine consumed in the first 48 hours after surgery
Time Frame
48 hours
Secondary Outcome Measure Information:
Title
Postoperative pain H12
Description
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
Title
Postoperative pain H24
Description
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
Title
Postoperative pain H36
Description
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
Title
Postoperative pain H48
Description
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
Title
Postoperative pain D30
Description
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
Title
Mean arterial pressure
Description
Mean arterial pressure (MAP) (mmHg)
Time Frame
48 hours
Title
Mean arterial pressure variability
Description
MAP variability in percentage
Time Frame
48 hours
Title
Duration of Mean arterial pressure <65
Description
Duration of Mean arterial pressure <65 mmHg (min)
Time Frame
48 hours
Title
Duration of Mean arterial pressure <55
Description
Duration of Mean arterial pressure <65 mmHg (min)
Time Frame
48 hours
Title
Average heart rate
Description
Average heart rate
Time Frame
48 hours
Title
Heart rate variability
Description
Heart rate variability in percentage
Time Frame
48 hours
Title
Bradycardia duration < 50
Description
Bradycardia duration < 50 (min)
Time Frame
48 hours
Title
Atropine dose administered
Description
Atropine dose administered (mg)
Time Frame
48 hours
Title
Ephedrine dose administered
Description
Ephedrine dose administered (mg)
Time Frame
48 hours
Title
Noradrenaline dose administered
Description
Noradrenaline dose administered (ug)
Time Frame
48 hours
Title
Neosynephrine dose administered
Description
Neosynephrine dose administered (ug)
Time Frame
48 hours
Title
Urapidil dose
Description
Urapidil dose (mg)
Time Frame
48 hours
Title
Nicardipine dose
Description
Nicardipine dose (mg)
Time Frame
48 hours
Title
Postoperative hypoxemia
Description
Postoperative hypoxemia (Yes/No)
Time Frame
48 hours
Title
Consumption of non-morphine drug
Description
Consumption of NSAIDs, nefopam, tramadol, ondansetron and other antiemetics
Time Frame
Day 90
Title
Assessment of tolerance
Description
All adverse events will be collected and compared between the 2 groups
Time Frame
Day 90
Title
Assessment of disability
Description
Assessment of disability with the World Health Organization Disability Assessment Schedule (WHODAS2.0)
Time Frame
Day 30
Title
Assessment of disability
Description
Assessment of disability with the World Health Organization Disability Assessment Schedule (WHODAS2.0). Evolution between Day 30 and Day 90.
Time Frame
Day 90
Title
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
Description
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
Title
Immediate postoperative hypoxemia
Description
Immediate postoperative hypoxemia
Time Frame
Day 1
Title
Oxygen requirement
Description
Oxygen requirement (yes/no at D0, D1, D2)
Time Frame
Day 2

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Vincent COLLANGE, MD
Phone
06 47 47 97 52
Ext
33
Email
collangev@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Jean-Baptiste BERRUET, MD
Phone
06 66 46 11 90
Ext
33
Email
jeanbaptiste.berruet@gmail.com
Facility Information:
Facility Name
Hôpital Privé Médipôle
City
Villeurbanne
ZIP/Postal Code
69100
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vincent COLLANGE, MD
Phone
06 47 47 97 52
Email
collangev@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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