Bariatric Dose-ranging Study With Dexmedetomidine

NCT ID: NCT00363935

Last Updated: 2019-01-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE4

Study Classification

INTERVENTIONAL

Study Start Date

2007-01-01

Study Completion Date

2007-01-01

Brief Summary

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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.

Detailed Description

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Conditions

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Abdominal Surgery Patients

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

DOUBLE

Interventions

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Dexmedetomidine

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Texas Southwestern Medical Center

OTHER

Sponsor Role lead

Principal Investigators

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Paul White, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

UT Southwestern Medical Center at Dallas

Locations

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The University of Texas Southwestern MedicalCenter at Dallas

Dallas, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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072005-020

Identifier Type: -

Identifier Source: org_study_id

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