Effects of Propofol on Early Recovery of Hunger After Surgery (Propo-Faim)
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|ClinicalTrials.gov Identifier: NCT02272166|
Recruitment Status : Completed
First Posted : October 22, 2014
Last Update Posted : December 21, 2017
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|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||116 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Care Provider)|
|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|
Active Comparator: propofol
Hypnotic used in this arm is exclusively intra-venous propofol.
Other Name: diprivan, 2,6-bis(propan-2-yl)phénol
Active Comparator: sevoflurane
Hypnotic used in this arm is exclusively inhaled sevoflurane.
Other Name: Sevorane, 1,1,1,3,3,3-hexafluoro-2-(fluorométhoxy)propane
- 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).
- 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.
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
|Rouen University Hospital|
|Rouen, France, 76031|
|Study Chair:||Bertrand Dureuil, MD-PHD||Departement of Anesthesia, University Hospital, Rouen|
|Principal Investigator:||Emmanuel BESNIER, MD||Departement of Anesthesia, University Hospital, Rouen|