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

N/ACompletedNCT02063620

Duzce University60 enrolled

Overview

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.

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

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

Conditions

Qt Interval, Variation in

Interventions

Ketamine HCLDRUG

ketamine HCL is using as adjuvant agent with local anesthetic agent in regional intravenous anesthesia procedure routinely

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Duzce Univercity Medical Fauculty

Düzce, Turkey (Türkiye)

Outcomes

Primary Outcomes

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.

Time frame: Change QT and QTc intervals from baseline to 60 minutes

Secondary Outcomes

mean arteryel pressure

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

Time frame: Change of mean arteryel pressure from baseline to 60 minutes

Data from ClinicalTrials.gov

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