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

Obesity Clinical Trial

— COCOPOPONO  

Official title:

Comparison of Plasmatic Concentrations of Propofol and Remifentanil During Monitored Anesthesia in Obese and Non Obese Patients.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04492813
• Other study ID #: COCOPOPONO
• Status: Completed
• Phase: N/A
• Start date: December 20, 2018
• Est. completion date: May 25, 2021

Study information

• Verified date: August 2021
• Source: University Hospital, Clermont-Ferrand
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: May 25, 2021
• Est. primary completion date: January 25, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• General Anesthesia
• Obesity

Intervention

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

Locations

Country	Name	City	State
France	Service d'Anesthésie-Réanimation, Pôle Médecine Périopératoire - Hôpital Estaing, CHU de Clermont-Ferrand	Clermont-Ferrand	Puy De Dôme

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Clermont-Ferrand

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	Plasma concentration of Propofol	Plasma concentration of Propofol at different times during the maintenance phase of general anesthesia	At the exsufflation of the pneumoperitoneum
Primary	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
Primary	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
Primary	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
Primary	Plasma concentration of Remifentanil	Plasma concentration of Remifentanil at different times during the maintenance phase of general anesthesia	At the exsufflation of the pneumoperitoneum