Bariatric Dose-Ranging Study With Dexmedetomidine

This study has been completed.
Sponsor:
Information provided by:
University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier:
NCT00363935
First received: August 10, 2006
Last updated: April 17, 2007
Last verified: April 2007
  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-Blind
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

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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
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: 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

No publications provided

ClinicalTrials.gov Identifier: NCT00363935     History of Changes
Other Study ID Numbers: 072005-020
Study First Received: August 10, 2006
Last Updated: April 17, 2007
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Dexmedetomidine
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
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

ClinicalTrials.gov processed this record on October 19, 2014