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

December 15, 2023 updated by: GCS Ramsay Santé pour l'Enseignement et la Recherche
Evaluation of the benefit of non-opioid general anaesthesia on postoperative pain in laparoscopic colonic surgery

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
160

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Morphine Use
Time Frame: 48 hours
All intravenous and oral morphine consumed in the first 48 hours after surgery
48 hours

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Postoperative pain H12
Time Frame: Hour 12
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
Time Frame: Hour 24
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
Time Frame: Hour 36
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
Time Frame: Hour 48
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
Time Frame: Day 30
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
Time Frame: 48 hours
Mean arterial pressure (MAP) (mmHg)
48 hours
Mean arterial pressure variability
Time Frame: 48 hours
MAP variability in percentage
48 hours
Duration of Mean arterial pressure <65
Time Frame: 48 hours
Duration of Mean arterial pressure <65 mmHg (min)
48 hours
Duration of Mean arterial pressure <55
Time Frame: 48 hours
Duration of Mean arterial pressure <65 mmHg (min)
48 hours
Average heart rate
Time Frame: 48 hours
Average heart rate
48 hours
Heart rate variability
Time Frame: 48 hours
Heart rate variability in percentage
48 hours
Bradycardia duration < 50
Time Frame: 48 hours
Bradycardia duration < 50 (min)
48 hours
Atropine dose administered
Time Frame: 48 hours
Atropine dose administered (mg)
48 hours
Ephedrine dose administered
Time Frame: 48 hours
Ephedrine dose administered (mg)
48 hours
Noradrenaline dose administered
Time Frame: 48 hours
Noradrenaline dose administered (ug)
48 hours
Neosynephrine dose administered
Time Frame: 48 hours
Neosynephrine dose administered (ug)
48 hours
Urapidil dose
Time Frame: 48 hours
Urapidil dose (mg)
48 hours
Nicardipine dose
Time Frame: 48 hours
Nicardipine dose (mg)
48 hours
Postoperative hypoxemia
Time Frame: 48 hours
Postoperative hypoxemia (Yes/No)
48 hours
Consumption of non-morphine drug
Time Frame: Day 90
Consumption of NSAIDs, nefopam, tramadol, ondansetron and other antiemetics
Day 90
Assessment of tolerance
Time Frame: Day 90
All adverse events will be collected and compared between the 2 groups
Day 90
Assessment of disability
Time Frame: Day 30
Assessment of disability with the World Health Organization Disability Assessment Schedule (WHODAS2.0)
Day 30
Assessment of disability
Time Frame: Day 90
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 Frame: Day 90 at least
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
Time Frame: Day 1
Immediate postoperative hypoxemia
Day 1
Oxygen requirement
Time Frame: Day 2
Oxygen requirement (yes/no at D0, D1, D2)
Day 2

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
GCS Ramsay Santé pour l'Enseignement et la Recherche

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 17, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 17, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 17, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 16, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 26, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 1, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 18, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 15, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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