NCT00363935

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jan 2007

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 10, 2006

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 15, 2006

Completed
5 months until next milestone

Study Start

First participant enrolled

January 1, 2007

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2007

Completed
Last Updated

January 16, 2019

Status Verified

January 1, 2019

Enrollment Period

Same day

First QC Date

August 10, 2006

Last Update Submit

January 15, 2019

Conditions

Abdominal Surgery Patients

Interventions

DexmedetomidineDRUG

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The University of Texas Southwestern MedicalCenter at Dallas

Dallas, Texas, 75390-9068, United States

Location

MeSH Terms

Interventions

Dexmedetomidine

Intervention Hierarchy (Ancestors)

ImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Paul White, MD, PhD

    UT Southwestern Medical Center at Dallas

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 10, 2006

First Posted

August 15, 2006

Study Start

January 1, 2007

Primary Completion

January 1, 2007

Study Completion

January 1, 2007

Last Updated

January 16, 2019

Record last verified: 2019-01

Locations

US(1)