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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Drug: Calcium channel blocker and beta blocker
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:
  • Diltizem , Brevibloc
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
Drug: Calcium channel blocker and beta blocker
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:
  • Diltizem , Brevibloc

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Decrease in blood pressure
Time Frame: 2 hours
2 hours

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ankara University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2014

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 13, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 13, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 18, 2014

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 18, 2014

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 13, 2014

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 04-130-14

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