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Bariatric Dose-Ranging Study With Dexmedetomidine

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00363935
Recruitment Status : Completed
First Posted : August 15, 2006
Last Update Posted : April 18, 2007
Information provided by:
University of Texas Southwestern Medical Center

Brief Summary:
After obtaining informed consent,80 morbidly obese ASA II-III patients undergoing laparoscopic bariatric surgery procedures would be randomly assigned to one of four study groups at UTSWMC at Dallas.Hemodynamic paarameters, recovery times, postoperative pain scores, the need for rescue analgesics and side effects will be recorded.The purpose of this study is to determine the optimal linfusion rate of dexmedetomidine for maintaining cardiovscular stability during general anesthesia.

Condition or disease Intervention/treatment Phase
Abdominal Surgery Patients Drug: Dexmedetomidine Phase 4

Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Official Title: A Randomized, Double-Blind, Controlled Study of Dexmedetomidine (Precedex) Infusion for Improving Control of Acute Autonomic Response During Laparoscopic Bariatric Surgery

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All

Inclusion Criteria:

Subjects may be included in the study only if they meet all of the following criteria:

  1. Age 18 to 70 years
  2. Undergo laparoscopic bariatric surgery requiring general anesthesia
  3. Be capable of giving informed consent
  4. ASA physical status I-III ( Appendix 1)

Exclusion Criteria:

  1. Subjects will be excluded from the study for any of the following reasons:
  2. With history of hypertension and allergy to dexmedetomidine
  3. Patients who have greater than first degree heart block.
  4. Performing major intracavitary surgery procedures
  5. Patients who are pregnant or breast-feeding
  6. History of alcohol or drug abuse

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00363935

United States, Texas
The University of Texas Southwestern MedicalCenter at Dallas
Dallas, Texas, United States, 75390-9068
Sponsors and Collaborators
University of Texas Southwestern Medical Center
Principal Investigator: Paul White, MD, PhD UT Southwestern Medical Center at Dallas Identifier: NCT00363935     History of Changes
Other Study ID Numbers: 072005-020
First Posted: August 15, 2006    Key Record Dates
Last Update Posted: April 18, 2007
Last Verified: April 2007

Additional relevant MeSH terms:
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action