- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02319161
Comparison of Calcium Channel Blockers and Beta Blockers on Tourniquet-induced Hypertension During Intravenous Regional Anesthesia
December 13, 2014 updated by: Sanem Cakar Turhan, Ankara University
Comparison of Calcium-channel Blockers and Beta Blockers in Tourniquet-induced Hypertension During Intravenous Regional Anesthesia
The investigators aimed to investigate the efficacy of calcium channel blockers and beta blockers for controlling tourniquet induced blood pressure increase in patients undergoing carpal tunnel operations with IVRA.
For this purpose files of patients undergoing operation under IVRA were retrospectively examined in terms of demographical and hemodynamic variables.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
After approval of the University Research Ethics Committee, the files of patients who have been operated under intravenous regional anesthesia (IVRA) in orthopedics clinics between January 2009 and January 2010 were retrospectively investigated.
A total of 312 patients, 164 patients with carpal tunnel syndrome and 148 patients with trigger finger have been operated under IVRA.
Out of 164 patients who have been operated due to carpal tunnel syndrome, 50 patients in which either calcium channel blockers or beta blockers were used for treatment of critical blood pressure increase after tourniquet inflation and in which whole data were obtained, were included to the study.The patients with systolic blood pressure above to 150 mmHg following tourniquet inflation and in which bolus dose of diltiazem 10 mg (Group I) or calcium channel blocker 0.5mg/kg (Group II) have been administered by intravenous route constituted the study groups.
Demographical characteristics and hemodynamic parameters were recorded from the patient files.
Study Type
Observational
Enrollment (Actual)
50
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
45 years to 55 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
The files of patients who were operated on under intravenous regional anesthesia (IVRA) in orthopedics clinics between January 2009 and January 2010 were retrospectively investigated.
A total of 312 patients, 164 patients with carpal tunnel syndrome and 148 patients with trigger finger were operated on under IVRA.
Out of 164 patients who were operated on due to carpal tunnel syndrome, 50 patients in which either calcium channel blockers or beta blockers were used for treatment of critical blood pressure increase after tourniquet inflation and in which whole data were obtained, were included in the study.
Description
Inclusion Criteria:
Patients operated due to carpal tunnel syndrome under intravenous regional anesthesia betweem January 2009 and January 2010.
Exclusion Criteria:
The patients that the files could not be reached
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Retrospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Group I
Group I: the patients with systolic blood pressure above to 150 mmHg following tourniquet inflation and in which bolus dose of calcium channel blocker 10 mg was administered by intravenous route.
|
The patients in which systolic blood pressure increased to 150 mmHg and above following tourniquet inflation and in which a bolus dose of calcium channel blocker 10 mg (Diltizem, Mustafa Nevzat İlaç Sanayi Aş) (Group I) or beta blocker 0.5mg/kg (Brevibloc, Eczacıbaşı İlaç Sanayi Aş) (Group II) were administered intravenously constituted the study groups.
Other Names:
|
|
Group II
Group II: the patients with systolic blood pressure above to 150 mmHg following tourniquet inflation and in which bolus dose of beta blocker 0.5mg/kg was administered by intravenous route
|
The patients in which systolic blood pressure increased to 150 mmHg and above following tourniquet inflation and in which a bolus dose of calcium channel blocker 10 mg (Diltizem, Mustafa Nevzat İlaç Sanayi Aş) (Group I) or beta blocker 0.5mg/kg (Brevibloc, Eczacıbaşı İlaç Sanayi Aş) (Group II) were administered intravenously constituted the study groups.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Decrease in blood pressure
Time Frame: 2 hours
|
2 hours
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Decrease in pain
Time Frame: 2 hours
|
2 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: K. Sanem Çakar Turhan, Specialist, Ankara University Medical Faculty
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2014
Primary Completion (Actual)
September 1, 2014
Study Completion (Actual)
October 1, 2014
Study Registration Dates
First Submitted
December 13, 2014
First Submitted That Met QC Criteria
December 13, 2014
First Posted (Estimate)
December 18, 2014
Study Record Updates
Last Update Posted (Estimate)
December 18, 2014
Last Update Submitted That Met QC Criteria
December 13, 2014
Last Verified
December 1, 2014
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Hypertension
- Physiological Effects of Drugs
- Adrenergic Antagonists
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Membrane Transport Modulators
- Calcium-Regulating Hormones and Agents
- Adrenergic beta-1 Receptor Antagonists
- Calcium
- Esmolol
- Calcium Channel Blockers
- Adrenergic beta-Antagonists
Other Study ID Numbers
- 04-130-14
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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