Effects of Propofol on Early Recovery of Hunger After Surgery

Anesthesia Clinical Trial

— Propo-Faim  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02272166
• Other study ID #: 2014/088/HP
• Status: Completed
• Phase: Phase 4
• First received: October 15, 2014
• Last updated: December 20, 2017
• Start date: November 2014
• Est. completion date: July 2016

Study information

• Verified date: December 2017
• Source: University Hospital, Rouen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 116
• Est. completion date: July 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Ambulatory Surgery
• Anesthesia
• Energy Expenditure
• Food Intake

Intervention

Drug:
• propofol

• Sevoflurane

Locations

Country	Name	City	State
France	Rouen University Hospital	Rouen

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Rouen	Centre Henri Becquerel

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Feeding comfort	Amount of food intake evaluated by a specific scale	1-4 hours
Secondary	Post operative nausea and vomiting		1-4 hours
Secondary	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
Secondary	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
Secondary	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
Secondary	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