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

University Hospital, Rouen

Status and phase: Completed; Phase 4

Conditions: Ambulatory Surgery; Energy Expenditure; Food Intake; Anesthesia

Treatments: Drug: Sevoflurane; Drug: propofol

Study type: Interventional

Funder types: Other

Identifiers

NCT02272166

2014/088/HP

Details and patient eligibility

About

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.

Enrollment: 116 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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116 participants in 2 patient groups

propofol

Active Comparator group

Description:

Hypnotic used in this arm is exclusively intra-venous propofol.

Treatment:

Drug: propofol

sevoflurane

Active Comparator group

Description:

Hypnotic used in this arm is exclusively inhaled sevoflurane.

Treatment:

Drug: Sevoflurane