Abdominal Surgery PatientsPhase 4NCT00363935
Bariatric Dose-ranging Study With Dexmedetomidine
A Phase 4 study testing Dexmedetomidine in people with Abdominal Surgery Patients, run by University of Texas Southwestern Medical Center at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Abdominal Surgery Patients
- What is being tested?
- Dexmedetomidine
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2007to 1 Jan 2007
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Texas Southwestern MedicalCenter at Dallas
Dallas, Texas, 75390-9068
About this study
Official title: A Randomized, Double-blind, Controlled Study of Dexmedetomidine (Precedex) Infusion for Improving Control of Acute Autonomic Response During Laparoscopic Bariatric Surgery
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.
- Conditions
- Abdominal Surgery Patients
- Being tested
- Dexmedetomidine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2006 (estimated)
- Study start1 Jan 2007 (estimated)
- Primary completion1 Jan 2007 (estimated)
- Study completion1 Jan 2007 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Abdominal Surgery PatientsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Investigators
- Paul White, MD, PhD, Principal investigator, UT Southwestern Medical Center at Dallas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00363935
- Sponsor's protocol ID
- 072005-020
- Status last verified
- Jan 2019
- First submitted
- 10 Aug 2006
- Last updated
- 16 Jan 2019
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Controlled Study of Dexmedetomidine (Precedex) Infusion for Improving Control of Acute Autonomic Response During Laparoscopic Bariatric Surgery
- ClinicalTrials.gov ID
- NCT00363935
- Acronym / sponsor ID
- 072005-020
- Conditions
- Abdominal Surgery Patients
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Study start
- 1 Jan 2007 (estimated)
- Primary completion
- 1 Jan 2007 (estimated)
- Study completion
- 1 Jan 2007 (estimated)
- First posted
- 15 Aug 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dexmedetomidine | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paul White, MD, PhD principal investigator
UT Southwestern Medical Center at Dallas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dexmedetomidine in people with Abdominal Surgery Patients, run by University of Texas Southwestern Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 16 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2019.