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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-12-20

Study Completion Date

2021-05-25

Brief Summary

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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.

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Detailed Description

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Remifentanil and Propofol are administered intravenously as an opioid pain reliever and hypnotic pain reliever during anesthesia. Their advantages are numerous: short half-life allowing anesthesia and rapid awakening, little accumulation, allowing to adapt the level of anesthesia or sedation to each patient, few side effects.

Entropy° is an index derived from the electroencephalographic signal of patients, validated for the evaluation of the level of narcosis during general anesthesia.

ANI ° (nociception index analgesia) is an index using the ventilatory physiological variability of the sinus rhythm validated to monitor patient's analgesia during general anesthesia.

These non-invasive means of analgesia and sedation monitoring allows the clinician to ensure satisfactory levels of anesthesia by administering products at minimum effective doses.

The authors propose to determine whether, for a comparable target effect (analgesia and monitored sedation), plasmatic concentrations and administration rates of propofol and remifentanil necessary during general anesthesia for a comparable surgical stimulus are the same in populations of obese and non obese patients.

Conditions

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General Anesthesia Obesity

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

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).

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Obese patients

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

Group Type EXPERIMENTAL

Pharmacokinetic of propofol and remifentanil

Intervention Type DRUG

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

Non Obese patients

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

Group Type ACTIVE_COMPARATOR

Pharmacokinetic of propofol and remifentanil

Intervention Type DRUG

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

Interventions

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Pharmacokinetic of propofol and remifentanil

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

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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.

Exclusion Criteria

* 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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No