Bariatric Dose-ranging Study With Dexmedetomidine | NCT00363935

Studies
Bariatric Dose-ranging Study With Dexmedetomidine

NCT00363935

Sponsor

University of Texas Southwestern Medical Center

Status

Withdrawn

Last Update Posted

Jan 16, 2019Actual

Enrollment

0Actual

Phase

Phase 4

Conditions

Abdominal Surgery Patients

Interventions

Dexmedetomidine

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2019

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Not provided

Start Date

Jan 1, 2007Estimated

Primary Completion Date

Jan 1, 2007Estimated

Completion Date

Jan 1, 2007Estimated

First Submitted Date

Aug 10, 2006

First Submission Date that Met QC Criteria

Aug 10, 2006

First Posted Date

Aug 15, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 15, 2019

Last Update Posted Date

Jan 16, 2019Actual

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Name	Type	Description	Arm Group Labels	Other Names
Dexmedetomidine	Drug

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Paul White, MD, PhD	UT Southwestern Medical Center at Dallas	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The University of Texas Southwestern MedicalCenter at Dallas		Dallas	Texas	75390-9068	United States

Intervention Browse Module

MeSH Terms

ID	Term
D020927	Dexmedetomidine

Ancestor Terms

ID	Term
D007093	Imidazoles
D001393	Azoles
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds

Browse Leaves

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Browse Branches

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