Bariatric Dose-Ranging Study With Dexmedetomidine - Full Text View

Bariatric Dose-Ranging Study With Dexmedetomidine

This study has been completed.

Sponsored by:	University of Texas Southwestern Medical Center
Information provided by:	University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier:	NCT00363935

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 IV

MedlinePlus related topics:

Weight Loss Surgery

ChemIDplus related topics:

Dexmedetomidine Dexmedetomidine hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Randomized, Double-Blind, Placebo Control, Parallel Assignment

Official Title:	A Randomized, Double-Blind, Controlled Study of Dexmedetomidine (Precedex) Infusion for Improving Control of Acute Autonomic Response During Laparoscopic Bariatric Surgery

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:

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

Exclusion Criteria:

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

Contacts and Locations

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

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

Study placed in the following topic categories:

Dexmedetomidine

Additional relevant MeSH terms:

Neurotransmitter Agents

Adrenergic alpha-Agonists

Molecular Mechanisms of Pharmacological Action

Adrenergic Agents

Physiological Effects of Drugs

Central Nervous System Depressants

Pharmacologic Actions

Adrenergic Agonists

Analgesics, Non-Narcotic

Sensory System Agents

Therapeutic Uses

Hypnotics and Sedatives

Analgesics

Peripheral Nervous System Agents

Central Nervous System Agents

ClinicalTrials.gov processed this record on October 10, 2008