HypertensionNCT02319161
Comparison of Calcium Channel Blockers and Beta Blockers on Tourniquet-induced Hypertension During Intravenous Regional Anesthesia
An observational study of Hypertension, run by Ankara University.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 45 to 55 years
- Conditions the study is for
- Hypertension
- What is being tested?
- Calcium channel blocker and beta blocker
- Type of treatment
- Injection or infusion
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Jun 2014to Oct 2014
- Phase
- Observational
- 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 45 to 55 years
- All sexes
- No healthy volunteers
- Adult
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.
Who may be able to join
- Patients operated due to carpal tunnel syndrome under intravenous regional anesthesia betweem January 2009 and January 2010.
Who cannot join
- The patients that the files could not be reached
About this study
Official title: 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.
Read the 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.
- Conditions
- Hypertension
- Being tested
- Calcium channel blocker and beta blocker
- Keywords
- intravenous regional anesthesia
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Calcium channel blocker and beta blockerDrug
Also called Diltizem , Brevibloc
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Calcium channel blocker and beta blocker | |
| 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 Receives: Drug: Calcium channel blocker and beta blocker |
What is being measured
The primary outcome is the main question the study is designed to answer.
Decrease in blood pressure
Measured: 2 hours
Secondary outcomes (1)
Decrease in pain
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2014 (estimated)
- Study startJun 2014
- Primary completionSep 2014
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by Ankara UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sanem Cakar Turhan, Ankara University
- Investigators
- K. Sanem Çakar Turhan, Specialist, Principal investigator, Ankara University Medical Faculty
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02319161
- Sponsor's protocol ID
- 04-130-14
- Status last verified
- Dec 2014
- First submitted
- 13 Dec 2014
- Last updated
- 18 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Calcium-channel Blockers and Beta Blockers in Tourniquet-induced Hypertension During Intravenous Regional Anesthesia
- ClinicalTrials.gov ID
- NCT02319161
- Acronym / sponsor ID
- 04-130-14
- Conditions
- Hypertension
- Keywords
- intravenous regional anesthesia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Ankara UniversityUniversity, hospital or other
- Study start
- Jun 2014
- Primary completion
- Sep 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 18 Dec 2014 (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.
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.
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 design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group I | – | Drug: Calcium channel blocker and beta blockerGroup 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. |
| Group II | – | Drug: Calcium channel blocker and beta blockerGroup 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 |
Who may qualify
- Ages
- 45 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (1 listed)
- Patients operated due to carpal tunnel syndrome under intravenous regional anesthesia betweem January 2009 and January 2010.
Key exclusion criteria (1 listed)
- The patients that the files could not be reached
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 |
|---|---|---|
| Calcium channel blocker and beta blockerAlso: Diltizem , BreviblocThe 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. | Drug | Group I, Group II |
Primary outcome
Decrease in blood pressure
Time frame: 2 hours
1 secondary outcome
Decrease in pain
Time frame: 2 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2014.
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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.
K. Sanem Çakar Turhan, Specialist principal investigator
Ankara University Medical Faculty
Questions about this trial
What is this clinical trial studying?
An observational study of Hypertension, run by Ankara University.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 18 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
What does the primary outcome measure?
Decrease in blood pressure (time frame: 2 hours). It is what the study was designed to measure, not a finding.
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 18 Dec 2014.