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NCT Number: NCT02272166

Effects of Propofol on Early Recovery of Hunger After Surgery

Recovery of hunger is a source of comfort for patients after general anesthesia. Moreover, this aspect of post-operative period is often required for discharging patients from hospital after ambulatory surgery. Indeed, this item is part of a multi-parameter score (Chung score) whose validation evaluates patient's ability to return home.

The impact of anesthetics on hunger is largely unknown but few studies suggest an orexigenic effect of propofol compared to halogenated gases. These studies had neither the power nor the methodology to answer the question. The aim of our study is to evaluate the impact of propofol versus sevoflurane on early recovery of hunger after ambulatory surgery.

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Key information

Conditions

Ambulatory Surgery Anesthesia Energy Expenditure Food Intake

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Rouen University Hospital

Rouen, 76031, France

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 18-45 years old women
  • American Society of Anesthesiologists (ASA) score 1-2
  • Affiliated to a social security system
  • Undergoing an ambulatory surgery during more than 15 minutes with general anesthesia and control of upper airways (tracheal intubation or supraglottic mask or facial mask ventilation) for oocytes punction before in vitro fertilization
  • General anesthesia occuring between 8 and 10 am with respect of pre-operative fasting rules
  • APFEL risk score for nausea and vomiting ≤ 2/4
  • Ability to understand and read french
  • Signature of understood consent

Exclusion criteria

  • Other surgery than oocytes punction
  • Cognitive dysfunction
  • Undernutrition or risk factor of undernutrition (evolutive neoplasia, chronic alcoholism …)
  • BMI ≥ 35 kg/m²
  • Eating disorders
  • Diabetes mellitus
  • Chronic treatment with drugs modifying feeding behavior :
  • Benzodiazepines
  • Inhibitors of serotonin reuptake
  • Others
  • Non respect of pre-operative fasting rules
  • Indication for rapid sequence induction (gastro-oesophageal reflux, absence of gastric emptying …)
  • Contraindication to propofol (allergia to propofol, soybean or peanuts, past history of propofol infusion syndrome, unstable cardiovascular disease) or to sevoflurane (past history of malignant hyperthermia, epilepsy or liver disorders after administration of a halogenated anesthetic)
  • Pregnant or breastfeeding woman
  • Involvement in another clinical trial under 4 previous weeks

Treatment and study plan

Propofol

Drug

Other names: diprivan, 2,6-bis(propan-2-yl)phénol

Sevoflurane

Drug

Other names: Sevorane, 1,1,1,3,3,3-hexafluoro-2-(fluorométhoxy)propane

Primary outcomes

  1. Time before recovery of hunger after general anesthesia

    Time frame: 1-4 hours

    Time before appearance of of hunger (evaluated by a score above 50/100 mm on analogic visual scale) after the end of hypnotic administration (propofol or sevoflurane).

Secondary outcomes

  1. Feeding comfort

    Time frame: 1-4 hours

    Amount of food intake evaluated by a specific scale

  2. Post operative nausea and vomiting

    Time frame: 1-4 hours

  3. Validation of Chung score

    Time frame: 1-4 hours

    Time needed to obtain a Chung score superior or equal to 9/10, permitting the patient to return home

  4. Change in plasmatic leptin level

    Time frame: 0-3 hours

    Change in plasmatic leptin level (expressed in ng/ml) at the end of anesthesia, one and two hours later, compared with pre-operative value for each patient. Dosage is realized by ELISA method.

  5. Change in plasmatic insulin level

    Time frame: 0-3 hours

    Change in plasmatic insulin level (expressed in microU/ml) at the end of anesthesia, one and two hours later, compared with pre-operative value for each patient. Dosage is realized by ELISA method.

  6. Change in plasmatic ghrelin level

    Time frame: 0-3 hours

    Change in plasmatic ghrelin level (expressed in pg/ml) at the end of anesthesia, one and two hours later, compared with pre-operative value for each patient. Dosage is realized by ELISA method.

Sponsors and collaborators

Lead sponsor

University Hospital, Rouen

Other

Collaborators

  • Centre Henri Becquerel

Registry information

Official study title

Effects of Propofol on Early Recovery of Hunger After Ambulatory Surgery Compared With Sevoflurane

Acronym: Propo-Faim

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Oct 22, 2014
Registry last updated
Dec 21, 2017

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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