Qt Interval, Variation inNCT02063620
The Effect of Anesthetic Agents Management on ECG Changes of Patients Who Were Operated Under RIVA
A study testing Ketamine HCL in people with Qt Interval, Variation in, run by Duzce University at 1 site in Turkey (Türkiye).
Trial summary
IVRA can be performed with many local anesthetics and adjuvant agents. Investigators planned to compare cardiac effects and ECG changes by IVRA with lidocaine and lidocaine plus ketamine. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Qt Interval, Variation in
- What is being tested?
- Ketamine HCL
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Oct 2013to Jan 2014
- Phase
- Interventional
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients between 18-60 years
- ASA 1-2 physical status
- Undergoing IVRA for short operations on arm and forearm
Who cannot join
- Allergy to study drugs,
- Serious cardiac diseases,
- Respiratory diseases,
- Renal failure,
- Drug addiction,
- Pregnancy,
Show all 10Show fewer
- Liver failure,
- Hypertension,
- Genetic diseases of musculoskeletal system,
- Use of antiepileptic drugs, abnormal thyroid functions and operation period over 1 hour.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Duzce Univercity Medical Fauculty
Düzce, 81600
About this study
Official title: The Effect of Different Anesthetic Agents Management on Electrocardiographic Changes of Patients Who Were Operated Under Regional Intravenous Anesthesia
IVRA can be performed with many local anesthetics and adjuvant agents. Investigators planned to compare cardiac effects and ECG changes by IVRA with lidocaine and lidocaine plus ketamine.
Read the detailed description
Methods: Patients between 18-60 years, with score of ASA 1-2 and who were undergoing IVRA for short operations on arm and forearm were included. Systolic, diastolic and mean blood pressures, heart rate, SpO2, ECG, adverse effects during the operation were recorded. Double cuffed tourniquet were placed on the extremity to be operated to hinder nerve injuries. Venous blood in the extremity was purged with Esmarch bandage. Proximal cuff was inflated with a pressure 50-100 mmHg higher than systolic blood pressure and the bandage was displaced. Randomly patients were divided into 2 groups. Group 1: %0.5 Lidocaine+Ketamine 0.8 mg/kg; 40 ml. Group 2: %0.5 Lidocaine 40 ml. Anesthetic agent was injected with a rate of 20 ml/min. 20 minutes after injection the distal cuff was inflated and the proximal cuff deflated with a rate of 50 mmHg in every 3 minutes. 0,5,10,15,30,45,60 minutes after the beginning of deflation and 10 minutes after the deflation was completed ECG were recorded. PR,QT,QTc, RR were recorded.
- Conditions
- Qt Interval, Variation in
- Being tested
- Ketamine HCL
- Keywords
- IVRA, ketamine, lidocaine, ECG
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ketamine HCLDrug
Also called Include brande name: ketalar injectable
ketamine HCL is using as adjuvant agent with local anesthetic agent in regional intravenous anesthesia procedure routinely
| Study group | Role | What they receive |
|---|---|---|
| ketamine HCL | Active comparator | %0.5 Lidocaine+Ketamine HCL 0.8 mg/kg, total 40ml, single dose administration, 30 minute duration, total 200mg lidocaine Receives: Drug: Ketamine HCL |
| lidocaine+ serum physiologic | No intervention | % 0.5 lidocaine+ serum physiologic, total 40ml, total 200 mg lidocaine, 30 minute duration, single dose administration, |
What is being measured
The primary outcome is the main question the study is designed to answer.
QT and QTc intervals
0,5,10,15,30,45,60 minutes after the beginning of deflation and 10 minutes after the deflation was completed ECG were recorded. PR,QT,QTc, RR were recorded.
Measured: Change QT and QTc intervals from baseline to 60 minutes
Secondary outcomes (1)
mean arteryel pressure
0,5,10,15,30,45,60 minutes after the beginning of deflation and 10 minutes after the deflation was completed
Measured: Change of mean arteryel pressure from baseline to 60 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2014 (estimated)
- Study startOct 2013
- Primary completionJan 2014
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Qt Interval, Variation inStudies 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duzce University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ilknur Suidiye, Duzce University
- Investigators
- Gokce Akman Kose, Principal investigator, Duzce University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02063620
- Sponsor's protocol ID
- gokceakman
- Other IDs
- ilknurseker
- Status last verified
- Apr 2019
- First submitted
- 29 Jan 2014
- Last updated
- 22 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Different Anesthetic Agents Management on Electrocardiographic Changes of Patients Who Were Operated Under Regional Intravenous Anesthesia
- ClinicalTrials.gov ID
- NCT02063620
- Acronym / sponsor ID
- gokceakman
- Conditions
- Qt Interval, Variation in
- Keywords
- IVRA, ketamine, lidocaine, ECG
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Duzce UniversityUniversity, hospital or other
- Study start
- Oct 2013
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 14 Feb 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.
IVRA can be performed with many local anesthetics and adjuvant agents. Investigators planned to compare cardiac effects and ECG changes by IVRA with lidocaine and lidocaine plus ketamine.
Detailed description
Methods: Patients between 18-60 years, with score of ASA 1-2 and who were undergoing IVRA for short operations on arm and forearm were included. Systolic, diastolic and mean blood pressures, heart rate, SpO2, ECG, adverse effects during the operation were recorded. Double cuffed tourniquet were placed on the extremity to be operated to hinder nerve injuries. Venous blood in the extremity was purged with Esmarch bandage. Proximal cuff was inflated with a pressure 50-100 mmHg higher than systolic blood pressure and the bandage was displaced. Randomly patients were divided into 2 groups. Group 1: %0.5 Lidocaine+Ketamine 0.8 mg/kg; 40 ml. Group 2: %0.5 Lidocaine 40 ml. Anesthetic agent was injected with a rate of 20 ml/min. 20 minutes after injection the distal cuff was inflated and the proximal cuff deflated with a rate of 50 mmHg in every 3 minutes. 0,5,10,15,30,45,60 minutes after the beginning of deflation and 10 minutes after the deflation was completed ECG were recorded. PR,QT,QTc, RR were recorded.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ketamine HCL | Active comparator | Drug: Ketamine HCL%0.5 Lidocaine+Ketamine HCL 0.8 mg/kg, total 40ml, single dose administration, 30 minute duration, total 200mg lidocaine |
| lidocaine+ serum physiologic | No intervention | –% 0.5 lidocaine+ serum physiologic, total 40ml, total 200 mg lidocaine, 30 minute duration, single dose administration, |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Patients between 18-60 years
- ASA 1-2 physical status
- Undergoing IVRA for short operations on arm and forearm
Key exclusion criteria (10 listed)
- Allergy to study drugs,
- Serious cardiac diseases,
- Respiratory diseases,
- Renal failure,
- Drug addiction,
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 |
|---|---|---|
| Ketamine HCLAlso: Include brande name: ketalar injectableketamine HCL is using as adjuvant agent with local anesthetic agent in regional intravenous anesthesia procedure routinely | Drug | ketamine HCL |
Primary outcome
QT and QTc intervals
Time frame: Change QT and QTc intervals from baseline to 60 minutes
0,5,10,15,30,45,60 minutes after the beginning of deflation and 10 minutes after the deflation was completed ECG were recorded. PR,QT,QTc, RR were recorded.
1 secondary outcome
mean arteryel pressure
Time frame: Change of mean arteryel pressure from baseline to 60 minutes
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 22 Apr 2019.
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.
Gokce Akman Kose principal investigator
Duzce University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ketamine HCL in people with Qt Interval, Variation in, run by Duzce University at 1 site in Turkey (Türkiye).
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 3 inclusion and 10 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 22 Apr 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 Turkey (Türkiye). 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.
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?
QT and QTc intervals (time frame: Change QT and QTc intervals from baseline to 60 minutes). 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 22 Apr 2019.