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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02272166
Recruitment Status : Completed
First Posted : October 22, 2014
Last Update Posted : December 21, 2017
Sponsor:
Collaborator:
Centre Henri Becquerel
Information provided by (Responsible Party):
University Hospital, Rouen

Tracking Information
First Submitted Date  ICMJE October 15, 2014
First Posted Date  ICMJE October 22, 2014
Last Update Posted Date December 21, 2017
Study Start Date  ICMJE November 2014
Actual Primary Completion Date July 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 20, 2014)
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).
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 20, 2014)
  • Feeding comfort [ Time Frame: 1-4 hours ]
    Amount of food intake evaluated by a specific scale
  • Post operative nausea and vomiting [ Time Frame: 1-4 hours ]
  • 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
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effects of Propofol on Early Recovery of Hunger After Surgery
Official Title  ICMJE Effects of Propofol on Early Recovery of Hunger After Ambulatory Surgery Compared With Sevoflurane
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Condition  ICMJE
  • Ambulatory Surgery
  • Anesthesia
  • Energy Expenditure
  • Food Intake
Intervention  ICMJE
  • Drug: propofol
    Other Name: diprivan, 2,6-bis(propan-2-yl)phénol
  • Drug: Sevoflurane
    Other Name: Sevorane, 1,1,1,3,3,3-hexafluoro-2-(fluorométhoxy)propane
Study Arms  ICMJE
  • Active Comparator: propofol
    Hypnotic used in this arm is exclusively intra-venous propofol.
    Intervention: Drug: propofol
  • Active Comparator: sevoflurane
    Hypnotic used in this arm is exclusively inhaled sevoflurane.
    Intervention: Drug: Sevoflurane
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 20, 2014)
116
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 2016
Actual Primary Completion Date July 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02272166
Other Study ID Numbers  ICMJE 2014/088/HP
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University Hospital, Rouen
Study Sponsor  ICMJE University Hospital, Rouen
Collaborators  ICMJE Centre Henri Becquerel
Investigators  ICMJE
Study Chair: Bertrand Dureuil, MD-PHD Departement of Anesthesia, University Hospital, Rouen
Principal Investigator: Emmanuel BESNIER, MD Departement of Anesthesia, University Hospital, Rouen
PRS Account University Hospital, Rouen
Verification Date December 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP