Bariatric Dose-ranging Study With Dexmedetomidine

Abdominal Surgery Patients Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00363935
• Other study ID #: 072005-020
• Status: Withdrawn
• Phase: Phase 4
• Start date: January 1, 2007
• Est. completion date: January 1, 2007

Study information

• Verified date: January 2019
• Source: University of Texas Southwestern Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: January 1, 2007
• Est. primary completion date: January 1, 2007
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Abdominal Surgery Patients

Intervention

Drug:
• Dexmedetomidine

Locations

Country	Name	City	State
United States	The University of Texas Southwestern MedicalCenter at Dallas	Dallas	Texas

Sponsors (1)

Lead Sponsor	Collaborator
University of Texas Southwestern Medical Center

Country where clinical trial is conducted

United States,