Colectomy
Conditions
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
Interventions
DRUGanaesthesia without opiates
Anaesthesia without opiates for patients undergoing laparoscopic colectomy
DRUGanaesthesia with morphine
anaesthesia with morphine for patients undergoing laparoscopic colectomy
Sponsors
GCS Ramsay Santé pour l'Enseignement et la Recherche
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
The patient does not know which treatment is used for the anesthesia
Intervention 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
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Morphine Use | 48 hours | All intravenous and oral morphine consumed in the first 48 hours after surgery |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Duration of Mean arterial pressure <65 | 48 hours | Duration of Mean arterial pressure \<65 mmHg (min) |
| Duration of Mean arterial pressure <55 | 48 hours | Duration of Mean arterial pressure \<65 mmHg (min) |
| Average heart rate | 48 hours | Average heart rate |
| Heart rate variability | 48 hours | Heart rate variability in percentage |
| Bradycardia duration < 50 | 48 hours | Bradycardia duration \< 50 (min) |
| Atropine dose administered | 48 hours | Atropine dose administered (mg) |
| Ephedrine dose administered | 48 hours | Ephedrine dose administered (mg) |
| Noradrenaline dose administered | 48 hours | Noradrenaline dose administered (ug) |
| Neosynephrine dose administered | 48 hours | Neosynephrine dose administered (ug) |
| Urapidil dose | 48 hours | Urapidil dose (mg) |
| Nicardipine dose | 48 hours | Nicardipine dose (mg) |
| Postoperative pain H12 | 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. |
| Postoperative hypoxemia | 48 hours | Postoperative hypoxemia (Yes/No) |
| Postoperative pain H36 | 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. |
| Postoperative pain H48 | 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. |
| Postoperative pain D30 | 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. |
| Mean arterial pressure | 48 hours | Mean arterial pressure (MAP) (mmHg) |
| Mean arterial pressure variability | 48 hours | MAP variability in percentage |
| Consumption of non-morphine drug | Day 90 | Consumption of NSAIDs, nefopam, tramadol, ondansetron and other antiemetics |
| Assessment of tolerance | Day 90 | All adverse events will be collected and compared between the 2 groups |
| Assessment of disability | Day 30 | Assessment of disability with the World Health Organization Disability Assessment Schedule (WHODAS2.0) |
| 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 | 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 | Day 1 | Immediate postoperative hypoxemia |
| Oxygen requirement | Day 2 | Oxygen requirement (yes/no at D0, D1, D2) |
| Postoperative pain H24 | 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. |
Countries
France
Outcome results
None listed