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Completed

NCT Number: NCT05031234

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

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

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Key information

Conditions

Colectomy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hôpital Privé Médipôle

Villeurbanne, 69100, France

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

anaesthesia without opiates

Drug

Anaesthesia without opiates for patients undergoing laparoscopic colectomy

anaesthesia with morphine

Drug

anaesthesia with morphine for patients undergoing laparoscopic colectomy

Primary outcomes

  1. Morphine Use

    Time frame: 48 hours

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

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. Mean arterial pressure

    Time frame: 48 hours

    Mean arterial pressure (MAP) (mmHg)

  7. Mean arterial pressure variability

    Time frame: 48 hours

    MAP variability in percentage

  8. Duration of Mean arterial pressure <65

    Time frame: 48 hours

    Duration of Mean arterial pressure <65 mmHg (min)

  9. Duration of Mean arterial pressure <55

    Time frame: 48 hours

    Duration of Mean arterial pressure <65 mmHg (min)

  10. Average heart rate

    Time frame: 48 hours

    Average heart rate

  11. Heart rate variability

    Time frame: 48 hours

    Heart rate variability in percentage

  12. Bradycardia duration < 50

    Time frame: 48 hours

    Bradycardia duration < 50 (min)

  13. Atropine dose administered

    Time frame: 48 hours

    Atropine dose administered (mg)

  14. Ephedrine dose administered

    Time frame: 48 hours

    Ephedrine dose administered (mg)

  15. Noradrenaline dose administered

    Time frame: 48 hours

    Noradrenaline dose administered (ug)

  16. Neosynephrine dose administered

    Time frame: 48 hours

    Neosynephrine dose administered (ug)

  17. Urapidil dose

    Time frame: 48 hours

    Urapidil dose (mg)

  18. Nicardipine dose

    Time frame: 48 hours

    Nicardipine dose (mg)

  19. Postoperative hypoxemia

    Time frame: 48 hours

    Postoperative hypoxemia (Yes/No)

  20. Consumption of non-morphine drug

    Time frame: Day 90

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

  21. Assessment of tolerance

    Time frame: Day 90

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

  22. Assessment of disability

    Time frame: Day 30

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

  23. 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.

  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 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

  25. Immediate postoperative hypoxemia

    Time frame: Day 1

    Immediate postoperative hypoxemia

  26. Oxygen requirement

    Time frame: Day 2

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

Sponsors and collaborators

Lead sponsor

GCS Ramsay Santé pour l'Enseignement et la Recherche

Other

Registry information

Acronym: AGORA

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Sep 1, 2021
Registry last updated
Dec 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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