Ketamine in Bariatric Surgery

Phase 3

• Conditions: Morbid Obesity
• Interventions: Drug: ketamine; Drug: fentanyl

• Registration Number: NCT01724983
• Lead Sponsor: University of Padova

Brief Summary

Ketamine may improve recovery from bariatric surgery.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-06
• Study First Submitted: 2012-09-14
• Status Verified: 2012-11
• Study First Submitted QC: 2012-11-07
• Last Update Submitted: 2012-11-07
• Study First Posted: 2012-11-12
• Last Update Posted: 2012-11-12
• Primary Completion: 2014-06
• Study Completion: 2014-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

• age > 18
• obesity (Body Mass Index > 30)
• ASA classificazion < 4
• candidate to bariatric surgery

Exclusion Criteria

• known or presumed pregnancy
• previous surgery on the airway, esophagus or stomach
• uncontrolled psychiatric symptomatology

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ketamine	ketamine	patients will receive ketamine at induction
fentanyl	fentanyl	patients will receive fentanyl at induction

Primary Outcome Measures

Name	Time	Method
pain level	postoperatively, up to 3 months
mood level	postoperatively, up to 3 months

Secondary Outcome Measures

Name	Time	Method
total dosages of analgesic and muscle relaxant drugs	postoperatively, up to 3 months
postanesthetic recovery	postoperatively, up to 24 hours
satisfaction of the patient and of the surgeon	day 1
pulse oximetry saturation	postoperatively, up to 24 hours
lung volumes	postoperatively, up to 48 hours from end of surgery
antihemetic drug dosage	postoperatively, up to 24 hours
vasoactive drugs	intraoperatively and up to 24 hours from surgery end

Trial Locations

Locations (1)

Azienda Ospedaliera; 🇮🇹 Padova, PD, Italy