Plasmatic Concentrations of Propofol and Remifentanil in Obese and Non Obese Patients.

NCT04492813 | Completed

• 1 other identifier: COCOPOPONO
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

This prospective monocentric phamacokinetics study aims to compare plasmatic concentrations of Propofol and Remifentanil required to target a specific range of monitored anesthesia and analgesia during sus-mesocolic surgery in obese and non obese patients.

Conditions

General Anesthesia; Obesity

Keywords

General anesthesia; Obesity; Propofol pharmacokinetic; Remifentanyl pharmacokinetic

Outcome Measures

Primary Outcomes (8)

• Plasma concentration of Propofol

  Plasma concentration of Propofol at different times during the maintenance phase of general anesthesia

  5 minutes after the insufflation of the pneumoperitoneum

• Plasma concentration of Propofol

  Plasma concentration of Propofol at different times during the maintenance phase of general anesthesia

  5 minutes after completion of the gastric slice or ligation of the bile ducts

• Plasma concentration of Propofol

  Plasma concentration of Propofol at different times during the maintenance phase of general anesthesia

  At time of removing surgical specimen from the abdomen

• Plasma concentration of Propofol

  Plasma concentration of Propofol at different times during the maintenance phase of general anesthesia

  At the exsufflation of the pneumoperitoneum

• Plasma concentration of Remifentanil

  Plasma concentration of Remifentanil at different times during the maintenance phase of general anesthesia

  5 minutes after the insufflation of the pneumoperitoneum

• Plasma concentration of Remifentanil

  Plasma concentration of Remifentanil at different times during the maintenance phase of general anesthesia

  5 minutes after completion of the gastric slice or ligation of the bile ducts

• Plasma concentration of Remifentanil

  Plasma concentration of Remifentanil at different times during the maintenance phase of general anesthesia

  At time of removing surgical specimen from the abdomen

• Plasma concentration of Remifentanil

  Plasma concentration of Remifentanil at different times during the maintenance phase of general anesthesia

  At the exsufflation of the pneumoperitoneum

Study Arms (2)

Obese patients

EXPERIMENTAL

Severe and morbidly obese patients (35²≤BMI \<55)

Drug: Pharmacokinetic of propofol and remifentanil

Non Obese patients

ACTIVE COMPARATOR

Patients with normal weight or slightly overweight (19 \<BMI \<30).

Drug: Pharmacokinetic of propofol and remifentanil

Interventions

Pharmacokinetic of propofol and remifentanil DRUG

Pharmacokinetic of propofol and remifentanil in both population: Obese and non Obese patients

Non Obese patients; Obese patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Obese patients group:
• Age ≥ 18 years old
• Severe and morbidly obese patients (35kg / m2≤IMC \<55kg / m2).
• Patients undergoing general anesthesia for laparoscopic susmesocolic surgery (bariatric surgery or cholecystectomy).
• Patients who have given their consent in the manner described by the public health law of August 9, 2004.
• Patients benefiting from a Social Security scheme.
• Group of non-obese patients:
• Age ≥ 18 years old
• Patients with normal weight or slightly overweight (19 \<BMI \<30).
• Patients receiving general anesthesia for laparoscopic susmesocolic surgery (cholecystectomy).
• Patients who have given their consent in the manner described by the public health law of August 9, 2004.
• Patients benefiting from a Social Security scheme.

You may not qualify if:

• Patient refusal
• Age \<18 years old
• Protected adults and vulnerable persons
• Pace maker
• General anesthesia in the 24 hours preceding this surgery
• Proven or suspected dysautonomia
• Premedication by gabapentin Neurontin °
• Locoregional peri-medullary analgesia technique used concomitantly during the pre- and intraoperative period.
• Unbalanced dysrhythmic heart disease (AC / FA; extrasystoles; non-sinus rhythm)
• Pregnant or breastfeeding woman
• Intubation impossible planned
• Hypersensitivity to the products used
• Allergy to peanut or soy

Sponsors & Collaborators

• University Hospital, Clermont-Ferrand: lead

Study Sites (1)

Service d'Anesthésie-Réanimation, Pôle Médecine Périopératoire - Hôpital Estaing, CHU de Clermont-Ferrand

Clermont-Ferrand, Puy De Dôme, 63000, France

Location

MeSH Terms

Conditions

Obesity

Interventions

Remifentanil

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Propionates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Jean-Etienne Bazin, Pr

  Service d'Anesthésie-Réanimation, Pôle Médecine Périopératoire - Hôpital Estaing, CHU de Clermont-Ferrand

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Each obese patient is matched with a non-obese patient by considering a pairing according to age (more or less 5 years), gender and renal function (more or less 10ml / min / 1.73m² creatinine clearance).

Study Record Dates

• First Submitted: July 27, 2020
• First Posted: July 30, 2020
• Study Start: December 20, 2018
• Primary Completion: January 25, 2021
• Study Completion: May 25, 2021
• Last Updated: August 25, 2021

Record last verified: 2021-08

Locations

FR (1)