Effects of Propofol on Early Recovery of Hunger After Surgery

Study Overview
=================
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.

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

Conditions
-----------------
Ambulatory Surgery, Anesthesia, Energy Expenditure, Food Intake

Intervention / Treatment
-----------------
* Drug: propofol
* Drug: Sevoflurane


Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: propofol<br>Hypnotic used in this arm is exclusively intra-venous propofol. | Drug: propofol<br> <br> * Other names: diprivan, 2,6-bis(propan-2-yl)phénol;|
| Active Comparator: sevoflurane<br>Hypnotic used in this arm is exclusively inhaled sevoflurane. | Drug: Sevoflurane<br> <br> * 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 |