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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

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.

Condition or disease Intervention/treatment Phase
Qt Interval, Variation in Drug: Ketamine HCL Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: The Effect of Different Anesthetic Agents Management on Electrocardiographic Changes of Patients Who Were Operated Under Regional Intravenous Anesthesia
Study Start Date : October 2013
Actual Primary Completion Date : January 2014
Actual Study Completion Date : January 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: ketamine HCL
%0.5 Lidocaine+Ketamine HCL 0.8 mg/kg, total 40ml, single dose administration, 30 minute duration, total 200mg lidocaine
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

No Intervention: lidocaine+ serum physiologic
% 0.5 lidocaine+ serum physiologic, total 40ml, total 200 mg lidocaine, 30 minute duration, single dose administration,



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02063620


Locations
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Turkey
Duzce Univercity Medical Fauculty
Duzce, Turkey, 81600
Sponsors and Collaborators
Duzce University
Investigators
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Principal Investigator: Gokce Akman Kose Duzce University School of Medicine

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Responsible Party: Ilknur Suidiye, assistant professor, Duzce University
ClinicalTrials.gov Identifier: NCT02063620     History of Changes
Other Study ID Numbers: gokceakman
ilknurseker ( Other Identifier: Duzce University )
First Posted: February 14, 2014    Key Record Dates
Last Update Posted: April 22, 2019
Last Verified: April 2019
Keywords provided by Ilknur Suidiye, Duzce University:
IVRA, ketamine, lidocaine, ECG
Additional relevant MeSH terms:
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Excitatory Amino Acid Antagonists
Lidocaine
Ketamine
Anesthetics
Anesthetics, Local
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Analgesics
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Excitatory Amino Acid Agents
Neurotransmitter Agents