We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Bariatric Dose-Ranging Study With Dexmedetomidine

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00363935
First Posted: August 15, 2006
Last Update Posted: April 18, 2007
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.
Information provided by:
University of Texas Southwestern Medical Center
  Purpose
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 Intervention Phase
Abdominal Surgery Patients Drug: Dexmedetomidine Phase 4

Study Type: Interventional
Study Design: 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 NLM:


Further study details as provided by University of Texas Southwestern Medical Center:

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


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

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
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00363935


Locations
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
Investigators
Principal Investigator: Paul White, MD, PhD UT Southwestern Medical Center at Dallas
  More Information

ClinicalTrials.gov Identifier: NCT00363935     History of Changes
Other Study ID Numbers: 072005-020
First Submitted: August 10, 2006
First Posted: August 15, 2006
Last Update Posted: April 18, 2007
Last Verified: April 2007

Additional relevant MeSH terms:
Dexmedetomidine
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics, Non-Narcotic
Analgesics
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