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

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.

Intervention / Treatment

  • Ketamine HCL (DRUG)
    ketamine HCL is using as adjuvant agent with local anesthetic agent in regional intravenous anesthesia procedure routinely

Condition or Disease

  • Qt Interval, Variation in

Phase

  • Not Applicable
  • Study Design

    Study type: INTERVENTIONAL
    Status: Completed
    Study results: No Results Available
    Age: 18 Years to 60 Years
    Enrollment: 60 (ACTUAL)
    Funded by: Other
    Allocation: Randomized
    Primary Purpose: Prevention

    Masking

    DOUBLE:
    • Participant
    • Investigator

    Clinical Trial Dates

    Start date: Oct 01, 2013
    Primary Completion: Jan 01, 2014 ACTUAL
    Completion Date: Jan 01, 2014 ACTUAL
    Study First Posted: Feb 14, 2014 ESTIMATED
    Results First Posted: Aug 31, 2020
    Last Updated: Apr 19, 2019

    Sponsors / Collaborators

    Lead Sponsor: Duzce University
    Responsible Party: N/A

    Location

    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.

    Participant Groups

    • %0.5 Lidocaine+Ketamine HCL 0.8 mg/kg, total 40ml, single dose administration, 30 minute duration, total 200mg lidocaine

    • % 0.5 lidocaine+ serum physiologic, total 40ml, total 200 mg lidocaine, 30 minute duration, single dose administration,

    Eligibility Criteria

    Sex: All
    Minimum Age: 18
    Maximum Age: 60
    Age Groups: Adult
    Healthy Volunteers: Yes

    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.

    Primary Outcomes
    • 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 Outcomes
    • 0,5,10,15,30,45,60 minutes after the beginning of deflation and 10 minutes after the deflation was completed

    More Details

    NCT Number: NCT02063620
    Other IDs: gokceakman
    Study URL: https://clinicaltrials.gov/study/NCT02063620
    Last updated: Sep 29, 2023