Ketamine in Bariatric Surgery

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
University of Padova
ClinicalTrials.gov Identifier:
NCT01724983
First received: September 14, 2012
Last updated: November 7, 2012
Last verified: November 2012
  Purpose

Ketamine may improve recovery from bariatric surgery.


Condition Intervention Phase
Morbid Obesity
Drug: ketamine
Drug: fentanyl
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Ketamine on Recovery From Bariatric Surgery

Resource links provided by NLM:


Further study details as provided by University of Padova:

Primary Outcome Measures:
  • pain level [ Time Frame: postoperatively, up to 3 months ] [ Designated as safety issue: Yes ]
  • mood level [ Time Frame: postoperatively, up to 3 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • total dosages of analgesic and muscle relaxant drugs [ Time Frame: postoperatively, up to 3 months ] [ Designated as safety issue: Yes ]
  • postanesthetic recovery [ Time Frame: postoperatively, up to 24 hours ] [ Designated as safety issue: Yes ]
  • satisfaction of the patient and of the surgeon [ Time Frame: day 1 ] [ Designated as safety issue: No ]
  • pulse oximetry saturation [ Time Frame: postoperatively, up to 24 hours ] [ Designated as safety issue: Yes ]
  • lung volumes [ Time Frame: postoperatively, up to 48 hours from end of surgery ] [ Designated as safety issue: Yes ]
  • antihemetic drug dosage [ Time Frame: postoperatively, up to 24 hours ] [ Designated as safety issue: Yes ]
  • vasoactive drugs [ Time Frame: intraoperatively and up to 24 hours from surgery end ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 90
Study Start Date: June 2012
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ketamine
patients will receive ketamine at induction
Drug: ketamine
Active Comparator: fentanyl
patients will receive fentanyl at induction
Drug: fentanyl

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01724983

Locations
Italy
Azienda Ospedaliera
Padova, PD, Italy, 35121
Sponsors and Collaborators
University of Padova
Investigators
Principal Investigator: Ulderico Freo, MD Università di Padova
  More Information

No publications provided

Responsible Party: University of Padova
ClinicalTrials.gov Identifier: NCT01724983     History of Changes
Other Study ID Numbers: KET2271
Study First Received: September 14, 2012
Last Updated: November 7, 2012
Health Authority: Italy: Ministry of Health

Keywords provided by University of Padova:
pain
mood
depression
respiration

Additional relevant MeSH terms:
Obesity, Morbid
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Ketamine
Fentanyl
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Analgesics, Opioid
Narcotics
Adjuvants, Anesthesia

ClinicalTrials.gov processed this record on October 19, 2014