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NCT Number: NCT04492813

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

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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Key information

Conditions

General Anesthesia Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Clermont-Ferrand, Puy De Dôme, 63000, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pharmacokinetic of propofol and remifentanil

Drug

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

Primary outcomes

  1. Plasma concentration of Propofol

    Time frame: 5 minutes after the insufflation of the pneumoperitoneum

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

  2. Plasma concentration of Propofol

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

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

  3. Plasma concentration of Propofol

    Time frame: At time of removing surgical specimen from the abdomen

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

  4. Plasma concentration of Propofol

    Time frame: At the exsufflation of the pneumoperitoneum

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

  5. Plasma concentration of Remifentanil

    Time frame: 5 minutes after the insufflation of the pneumoperitoneum

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

  6. Plasma concentration of Remifentanil

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

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

  7. Plasma concentration of Remifentanil

    Time frame: At time of removing surgical specimen from the abdomen

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

  8. Plasma concentration of Remifentanil

    Time frame: At the exsufflation of the pneumoperitoneum

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

Sponsors and collaborators

Lead sponsor

University Hospital, Clermont-Ferrand

Other

Registry information

Official study title

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

Acronym: COCOPOPONO

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Jul 30, 2020
Registry last updated
Aug 25, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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