Ketamine in Bariatric Surgery

November 7, 2012 updated by: University of Padova

Effects of Ketamine on Recovery From Bariatric Surgery

Ketamine may improve recovery from bariatric surgery.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

90

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • PD
      • Padova, PD, Italy, 35121
        • Azienda Ospedaliera

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ketamine
patients will receive ketamine at induction
Drug: ketamine
Active Comparator: fentanyl
patients will receive fentanyl at induction
Drug: fentanyl

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
pain level
Time Frame: postoperatively, up to 3 months
postoperatively, up to 3 months
mood level
Time Frame: postoperatively, up to 3 months
postoperatively, up to 3 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Padova

Investigators

  • Principal Investigator: Ulderico Freo, MD, University of Padova

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2012

Primary Completion (Anticipated)

June 1, 2014

Study Completion (Anticipated)

June 1, 2014

Study Registration Dates

First Submitted

September 14, 2012

First Submitted That Met QC Criteria

November 7, 2012

First Posted (Estimate)

November 12, 2012

Study Record Updates

Last Update Posted (Estimate)

November 12, 2012

Last Update Submitted That Met QC Criteria

November 7, 2012

Last Verified

November 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KET2271

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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