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The Effect of Anesthetic Agents Management on ECG Changes of Patients Who Were Operated Under RIVA

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ClinicalTrials.gov Identifier: NCT02063620
Recruitment Status : Completed
First Posted : February 14, 2014
Last Update Posted : April 22, 2019
Sponsor:
Information provided by (Responsible Party):
Ilknur Suidiye, Duzce University

Tracking Information
First Submitted Date  ICMJE January 29, 2014
First Posted Date  ICMJE February 14, 2014
Last Update Posted Date April 22, 2019
Study Start Date  ICMJE October 2013
Actual Primary Completion Date January 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 13, 2014)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 13, 2014)
mean arteryel pressure [ Time Frame: Change of mean arteryel pressure 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Effect of Anesthetic Agents Management on ECG Changes of Patients Who Were Operated Under RIVA
Official Title  ICMJE The Effect of Different Anesthetic Agents Management on Electrocardiographic Changes of Patients Who Were Operated Under Regional Intravenous Anesthesia
Brief 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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Condition  ICMJE Qt Interval, Variation in
Intervention  ICMJE Drug: Ketamine HCL
ketamine HCL is using as adjuvant agent with local anesthetic agent in regional intravenous anesthesia procedure routinely
Other Name: Include brande name: ketalar injectable
Study Arms  ICMJE
  • Active Comparator: ketamine HCL
    %0.5 Lidocaine+Ketamine HCL 0.8 mg/kg, total 40ml, single dose administration, 30 minute duration, total 200mg lidocaine
    Intervention: Drug: Ketamine HCL
  • No Intervention: lidocaine+ serum physiologic
    % 0.5 lidocaine+ serum physiologic, total 40ml, total 200 mg lidocaine, 30 minute duration, single dose administration,
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 13, 2014)
60
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE January 2014
Actual Primary Completion Date January 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Patients between 18-60 years
  2. ASA 1-2 physical status
  3. Undergoing IVRA for short operations on arm and forearm

Exclusion Criteria:

  1. Allergy to study drugs,
  2. Serious cardiac diseases,
  3. Respiratory diseases,
  4. Renal failure,
  5. Drug addiction,
  6. Pregnancy,
  7. Liver failure,
  8. Hypertension,
  9. Genetic diseases of musculoskeletal system,
  10. Use of antiepileptic drugs, abnormal thyroid functions and operation period over 1 hour.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Turkey
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02063620
Other Study ID Numbers  ICMJE gokceakman
ilknurseker ( Other Identifier: Duzce University )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Ilknur Suidiye, Duzce University
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Duzce University
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Gokce Akman Kose Duzce University School of Medicine
PRS Account Duzce University
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP