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Ketamine in Bariatric Surgery

Primary Purpose

Morbid Obesity

Status
Unknown status
Phase
Phase 3
Locations
Italy
Study Type
Interventional
Intervention
ketamine
fentanyl
Sponsored by
University of Padova
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Morbid Obesity focused on measuring pain, mood, depression, respiration

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Azienda Ospedaliera

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

ketamine

fentanyl

Arm Description

patients will receive ketamine at induction

patients will receive fentanyl at induction

Outcomes

Primary Outcome Measures

pain level
mood level

Secondary Outcome Measures

total dosages of analgesic and muscle relaxant drugs
postanesthetic recovery
satisfaction of the patient and of the surgeon
pulse oximetry saturation
lung volumes
antihemetic drug dosage
vasoactive drugs

Full Information

First Posted
September 14, 2012
Last Updated
November 7, 2012
Sponsor
University of Padova
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1. Study Identification

Unique Protocol Identification Number
NCT01724983
Brief Title
Ketamine in Bariatric Surgery
Official Title
Effects of Ketamine on Recovery From Bariatric Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
November 2012
Overall Recruitment Status
Unknown status
Study Start Date
June 2012 (undefined)
Primary Completion Date
June 2014 (Anticipated)
Study Completion Date
June 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Padova

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Ketamine may improve recovery from bariatric surgery.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Morbid Obesity
Keywords
pain, mood, depression, respiration

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
ketamine
Arm Type
Experimental
Arm Description
patients will receive ketamine at induction
Arm Title
fentanyl
Arm Type
Active Comparator
Arm Description
patients will receive fentanyl at induction
Intervention Type
Drug
Intervention Name(s)
ketamine
Intervention Type
Drug
Intervention Name(s)
fentanyl
Primary Outcome Measure Information:
Title
pain level
Time Frame
postoperatively, up to 3 months
Title
mood level
Time Frame
postoperatively, up to 3 months
Secondary Outcome Measure Information:
Title
total dosages of analgesic and muscle relaxant drugs
Time Frame
postoperatively, up to 3 months
Title
postanesthetic recovery
Time Frame
postoperatively, up to 24 hours
Title
satisfaction of the patient and of the surgeon
Time Frame
day 1
Title
pulse oximetry saturation
Time Frame
postoperatively, up to 24 hours
Title
lung volumes
Time Frame
postoperatively, up to 48 hours from end of surgery
Title
antihemetic drug dosage
Time Frame
postoperatively, up to 24 hours
Title
vasoactive drugs
Time Frame
intraoperatively and up to 24 hours from surgery end

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ulderico Freo, MD
Organizational Affiliation
University of Padova
Official's Role
Principal Investigator
Facility Information:
Facility Name
Azienda Ospedaliera
City
Padova
State/Province
PD
ZIP/Postal Code
35121
Country
Italy

12. IPD Sharing Statement

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Ketamine in Bariatric Surgery

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