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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

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.


Condition or disease Intervention/treatment Phase
Ambulatory Surgery Anesthesia Energy Expenditure Food Intake Drug: propofol Drug: Sevoflurane Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 116 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: Effects of Propofol on Early Recovery of Hunger After Ambulatory Surgery Compared With Sevoflurane
Study Start Date : November 2014
Actual Primary Completion Date : July 2016
Actual Study Completion Date : July 2016

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Arm Intervention/treatment
Active Comparator: propofol
Hypnotic used in this arm is exclusively intra-venous propofol.
Drug: propofol
Other Name: diprivan, 2,6-bis(propan-2-yl)phénol

Active Comparator: sevoflurane
Hypnotic used in this arm is exclusively inhaled sevoflurane.
Drug: Sevoflurane
Other Name: Sevorane, 1,1,1,3,3,3-hexafluoro-2-(fluorométhoxy)propane




Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02272166


Locations
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France
Rouen University Hospital
Rouen, France, 76031
Sponsors and Collaborators
University Hospital, Rouen
Centre Henri Becquerel
Investigators
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Study Chair: Bertrand Dureuil, MD-PHD Departement of Anesthesia, University Hospital, Rouen
Principal Investigator: Emmanuel BESNIER, MD Departement of Anesthesia, University Hospital, Rouen

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University Hospital, Rouen
ClinicalTrials.gov Identifier: NCT02272166    
Other Study ID Numbers: 2014/088/HP
First Posted: October 22, 2014    Key Record Dates
Last Update Posted: December 21, 2017
Last Verified: December 2017
Additional relevant MeSH terms:
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Propofol
Sevoflurane
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Platelet Aggregation Inhibitors
Anesthetics, Inhalation