Effects of Propofol on Early Recovery of Hunger After Surgery

NCT02272166 | Completed Phase 4 DMC

• 1 other identifier: 2014/088/HP
• Study Type: interventional
• Target: 116
• Locations: 1 country
• Sites: 1

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.

Conditions

Ambulatory Surgery; Anesthesia; Energy Expenditure; Food Intake

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Feeding comfort

  1-4 hours

• Post operative nausea and vomiting

  1-4 hours

• Validation of Chung score

  1-4 hours

• Change in plasmatic leptin level

  0-3 hours

• Change in plasmatic insulin level

  0-3 hours

Study Arms (2)

propofol

ACTIVE COMPARATOR

Hypnotic used in this arm is exclusively intra-venous propofol.

Drug: propofol

sevoflurane

ACTIVE COMPARATOR

Hypnotic used in this arm is exclusively inhaled sevoflurane.

Drug: Sevoflurane

Interventions

propofol DRUG

Also known as: diprivan, 2,6-bis(propan-2-yl)phénol

propofol

Sevoflurane DRUG

Also known as: Sevorane, 1,1,1,3,3,3-hexafluoro-2-(fluorométhoxy)propane

sevoflurane

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Rouen: lead
• Centre Henri Becquerel: collaborator

Study Sites (1)

Rouen University Hospital

Rouen, 76031, France

Location

Related Publications (1)

• 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.

  PMID: 31997087 DERIVED

MeSH Terms

Interventions

Propofol; Sevoflurane

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Methyl Ethers; Ethers; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated

Study Officials

• Bertrand Dureuil, MD-PHD

  Departement of Anesthesia, University Hospital, Rouen

  STUDY CHAIR

• Emmanuel BESNIER, MD

  Departement of Anesthesia, University Hospital, Rouen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 15, 2014
• First Posted: October 22, 2014
• Study Start: November 1, 2014
• Primary Completion: July 1, 2016
• Study Completion: July 1, 2016
• Last Updated: December 21, 2017

Record last verified: 2017-12

Locations

FR (1)