Effects of Propofol on Early Recovery of Hunger After Surgery (Propo-Faim)

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

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.

Study Overview

• Status: Completed
• Conditions: Anesthesia; Food Intake; Energy Expenditure; Ambulatory Surgery
• Intervention / Treatment: Drug: Sevoflurane; Drug: propofol

• Study Type: Interventional
• Enrollment (Actual): 116
• Phase: Phase 4

Contacts and Locations

Study Locations

• France
  • Rouen, France, 76031
    • Rouen University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: propofol; Hypnotic used in this arm is exclusively intra-venous propofol.	Drug: propofol; Other Names: diprivan, 2,6-bis(propan-2-yl)phénol
Active Comparator: sevoflurane; Hypnotic used in this arm is exclusively inhaled sevoflurane.	Drug: Sevoflurane; Other Names: Sevorane, 1,1,1,3,3,3-hexafluoro-2-(fluorométhoxy)propane

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time before recovery of hunger after general anesthesia	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).	1-4 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feeding comfort	Amount of food intake evaluated by a specific scale	1-4 hours
Post operative nausea and vomiting		1-4 hours
Validation of Chung score	Time needed to obtain a Chung score superior or equal to 9/10, permitting the patient to return home	1-4 hours
Change in plasmatic leptin level	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.	0-3 hours
Change in plasmatic insulin level	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.	0-3 hours
Change in plasmatic ghrelin level	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.	0-3 hours

Collaborators and Investigators

• Sponsor: University Hospital, Rouen
• Collaborators: Centre Henri Becquerel
• Investigators: Study Chair: Bertrand Dureuil, MD-PHD, Departement of Anesthesia, University Hospital, Rouen; Principal Investigator: Emmanuel BESNIER, MD, Departement of Anesthesia, University Hospital, Rouen

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: November 1, 2014
• Primary Completion (Actual): July 1, 2016
• Study Completion (Actual): July 1, 2016

Study Registration Dates

• First Submitted: October 15, 2014
• First Submitted That Met QC Criteria: October 20, 2014
• First Posted (Estimate): October 22, 2014

Study Record Updates

• Last Update Posted (Actual): December 21, 2017
• Last Update Submitted That Met QC Criteria: December 20, 2017
• Last Verified: December 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Platelet Aggregation Inhibitors; Hypnotics and Sedatives; Anesthetics, Inhalation; Propofol; Sevoflurane
• Other Study ID Numbers: 2014/088/HP