Clinical trial NCT04492813: Plasmatic Concentrations of Propofol and Remifentanil in Obese and Non Obese Patients.
Official title: Comparison of Plasmatic Concentrations of Propofol and Remifentanil During Monitored Anesthesia in Obese and Non Obese Patients.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: General Anesthesia
Obesity
Keywords: General anesthesia
Obesity
Propofol pharmacokinetic
Remifentanyl pharmacokinetic
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
First posted: 2020-07-30
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 purpose: BASIC_SCIENCE

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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Plasma concentration of Propofol
timeFrame: 5 minutes after the insufflation of the pneumoperitoneum
measure: Plasma concentration of Propofol
timeFrame: 5 minutes after completion of the gastric slice or ligation of the bile ducts
measure: Plasma concentration of Propofol
timeFrame: At time of removing surgical specimen from the abdomen
measure: Plasma concentration of Propofol
timeFrame: At the exsufflation of the pneumoperitoneum
measure: Plasma concentration of Remifentanil
timeFrame: 5 minutes after the insufflation of the pneumoperitoneum
measure: Plasma concentration of Remifentanil
timeFrame: 5 minutes after completion of the gastric slice or ligation of the bile ducts
measure: Plasma concentration of Remifentanil
timeFrame: At time of removing surgical specimen from the abdomen
measure: Plasma concentration of Remifentanil
timeFrame: At the exsufflation of the pneumoperitoneum
Secondary outcomes:
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: Service d'Anesthésie-Réanimation, Pôle Médecine Périopératoire - Hôpital Estaing, CHU de Clermont-Ferrand
state: Puy De Dôme
Study officials:
affiliation: Service d'Anesthésie-Réanimation, Pôle Médecine Périopératoire - Hôpital Estaing, CHU de Clermont-Ferrand
name: Jean-Etienne Bazin, Pr
role: PRINCIPAL_INVESTIGATOR
References: