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ColectomyAGORANCT05031234

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

A study testing anaesthesia without opiates and anaesthesia with morphine in people with Colectomy, run by GCS Ramsay Santé pour l'Enseignement et la Recherche at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Evaluation of the benefit of non-opioid general anaesthesia on postoperative pain in laparoscopic colonic surgery Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Colectomy
What is being tested?
anaesthesia without opiates and anaesthesia with morphine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
160 participants
Where
1 siteFrance
Study dates
17 Dec 2020to 17 Feb 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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 locations and contacts

1 site in 1 country.

France1 site

  • Hôpital Privé Médipôle

    Villeurbanne, 69100

Other trials in France

About this study

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

Read the 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
Conditions
Colectomy
Being tested
anaesthesia without opiates, anaesthesia with morphine

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • anaesthesia without opiatesDrug

    Anaesthesia without opiates for patients undergoing laparoscopic colectomy

  • anaesthesia with morphineDrug

    anaesthesia with morphine for patients undergoing laparoscopic colectomy

Study groups in NCT05031234
Study groupRoleWhat they receive
Group with morphineActive comparatorconventional general anaesthesia with morphine
Receives: Drug: anaesthesia with morphine
Group without opiatesExperimentalgeneral anaesthesia without opiates
Receives: Drug: anaesthesia without opiates

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Morphine Use

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

    Measured: 48 hours

Secondary outcomes (26)

  1. 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.

    Measured: Hour 12

  2. 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.

    Measured: Hour 24

  3. 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.

    Measured: Hour 36

  4. 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.

    Measured: Hour 48

  5. 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.

    Measured: Day 30

  6. Mean arterial pressure

    Mean arterial pressure (MAP) (mmHg)

    Measured: 48 hours

  7. Mean arterial pressure variability

    MAP variability in percentage

    Measured: 48 hours

  8. Duration of Mean arterial pressure <65

    Duration of Mean arterial pressure <65 mmHg (min)

    Measured: 48 hours

  9. Duration of Mean arterial pressure <55

    Duration of Mean arterial pressure <65 mmHg (min)

    Measured: 48 hours

  10. Average heart rate

    Average heart rate

    Measured: 48 hours

  11. Heart rate variability

    Heart rate variability in percentage

    Measured: 48 hours

  12. Bradycardia duration < 50

    Bradycardia duration < 50 (min)

    Measured: 48 hours

  13. Atropine dose administered

    Atropine dose administered (mg)

    Measured: 48 hours

  14. Ephedrine dose administered

    Ephedrine dose administered (mg)

    Measured: 48 hours

  15. Noradrenaline dose administered

    Noradrenaline dose administered (ug)

    Measured: 48 hours

  16. Neosynephrine dose administered

    Neosynephrine dose administered (ug)

    Measured: 48 hours

  17. Urapidil dose

    Urapidil dose (mg)

    Measured: 48 hours

  18. Nicardipine dose

    Nicardipine dose (mg)

    Measured: 48 hours

  19. Postoperative hypoxemia

    Postoperative hypoxemia (Yes/No)

    Measured: 48 hours

  20. Consumption of non-morphine drug

    Consumption of NSAIDs, nefopam, tramadol, ondansetron and other antiemetics

    Measured: Day 90

  21. Assessment of tolerance

    All adverse events will be collected and compared between the 2 groups

    Measured: Day 90

  22. Assessment of disability

    Assessment of disability with the World Health Organization Disability Assessment Schedule (WHODAS2.0)

    Measured: Day 30

  23. Assessment of disability

    Assessment of disability with the World Health Organization Disability Assessment Schedule (WHODAS2.0). Evolution between Day 30 and Day 90.

    Measured: Day 90

  24. 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

    Measured: Day 90 at least

  25. Immediate postoperative hypoxemia

    Immediate postoperative hypoxemia

    Measured: Day 1

  26. Oxygen requirement

    Oxygen requirement (yes/no at D0, D1, D2)

    Measured: Day 2

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Sep 2021
  2. Study start17 Dec 2020
  3. Primary completion17 Feb 2023
  4. Study completion17 Feb 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
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
Single blind
Who is masked
Participant
Enrolment
160 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05031234
Sponsor's protocol ID
2020-A02585-34
Acronym
AGORA
Status last verified
Dec 2023
First submitted
16 Aug 2021
Last updated
18 Dec 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Collange V, Berruet JB, Aubrun F, Poiblanc M, Olagne E, Golliet Mercier N, Parent S, Noel P, Devillez S, Perrou M, Ramadan J, Coeckelenbergh S, Joosten A. Opioid free versus opioid sparing strategies for multimodal antinociception during laparoscopic colectomy: a randomised controlled trial. Anaesth Crit Care Pain Med. 2024 Dec;43(6):101436. doi: 10.1016/j.accpm.2024.101436. Epub 2024 Oct 9.

    PubMed 39393528

Questions about this trial

What is this clinical trial studying?

A study testing anaesthesia without opiates and anaesthesia with morphine in people with Colectomy, run by GCS Ramsay Santé pour l'Enseignement et la Recherche at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Morphine Use (time frame: 48 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05031234, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2023.

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