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Bariatric Dose-ranging Study With Dexmedetomidine

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

Status
Withdrawn
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00363935
Enrollment
0
Registered
2006-08-15
Start date
2007-01-01
Completion date
2007-01-01
Last updated
2019-01-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Abdominal Surgery Patients

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.

Interventions

DRUGDexmedetomidine

Sponsors

University of Texas Southwestern Medical Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
DOUBLE

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026