Clinical trial NCT02272166: Effects of Propofol on Early Recovery of Hunger After Surgery
Official title: Effects of Propofol on Early Recovery of Hunger After Ambulatory Surgery Compared With Sevoflurane
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Ambulatory Surgery
Anesthesia
Energy Expenditure
Food Intake
Lead sponsor: University Hospital, Rouen
Sponsor class: OTHER
Collaborators: name: Centre Henri Becquerel
First posted: 2014-10-22
Enrollment: 116
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Time before recovery of hunger after general anesthesia
timeFrame: 1-4 hours
Secondary outcomes:
measure: Feeding comfort
timeFrame: 1-4 hours
measure: Post operative nausea and vomiting
timeFrame: 1-4 hours
measure: Validation of Chung score
timeFrame: 1-4 hours
measure: Change in plasmatic leptin level
timeFrame: 0-3 hours
measure: Change in plasmatic insulin level
timeFrame: 0-3 hours
measure: Change in plasmatic ghrelin level
timeFrame: 0-3 hours
Other outcomes:
Locations:
city: Rouen
country: France
facility: Rouen University Hospital
Study officials:
affiliation: Departement of Anesthesia, University Hospital, Rouen
name: Bertrand Dureuil, MD-PHD
role: STUDY_CHAIR
affiliation: Departement of Anesthesia, University Hospital, Rouen
name: Emmanuel BESNIER, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Besnier E, Perdrix A, Gillibert A, Selim J, Froemer B, Ghemired A, Berby B, Rives N, Dureuil B, Clavier T, Compere V. Postoperative hunger after outpatient surgery in patients anesthetized with propofol vs sevoflurane: a randomized-controlled trial. Can J Anaesth. 2020 May;67(5):550-559. doi: 10.1007/s12630-020-01584-w. Epub 2020 Jan 29.