Ketamine in Bariatric Surgery

Morbid Obesity Clinical Trial

Official title:

Effects of Ketamine on Recovery From Bariatric Surgery

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01724983
• Other study ID #: KET2271
• Status: Active, not recruiting
• Phase: Phase 3
• First received: September 14, 2012
• Last updated: November 7, 2012
• Start date: June 2012
• Est. completion date: June 2014

Study information

• Verified date: November 2012
• Source: University of Padova
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

Ketamine may improve recovery from bariatric surgery.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 90
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Morbid Obesity
• Obesity, Morbid

Intervention

Drug:
• ketamine

• fentanyl

Locations

Country	Name	City	State
Italy	Azienda Ospedaliera	Padova	PD

Sponsors (1)

Lead Sponsor	Collaborator
University of Padova

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pain level		postoperatively, up to 3 months	Yes
Primary	mood level		postoperatively, up to 3 months	Yes
Secondary	total dosages of analgesic and muscle relaxant drugs		postoperatively, up to 3 months	Yes
Secondary	postanesthetic recovery		postoperatively, up to 24 hours	Yes
Secondary	satisfaction of the patient and of the surgeon		day 1	No
Secondary	pulse oximetry saturation		postoperatively, up to 24 hours	Yes
Secondary	lung volumes		postoperatively, up to 48 hours from end of surgery	Yes
Secondary	antihemetic drug dosage		postoperatively, up to 24 hours	Yes
Secondary	vasoactive drugs		intraoperatively and up to 24 hours from surgery end	Yes