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

Not Applicable

Completed

• Conditions: Qt Interval, Variation in
• Interventions: Drug: Ketamine HCL

• Registration Number: NCT02063620
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2013-10
• Primary Completion: 2014-01
• Study Completion: 2014-01
• Study First Submitted: 2014-01-29
• Study First Submitted QC: 2014-02-13
• Study First Posted: 2014-02-14
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-19
• Last Update Posted: 2019-04-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
QT and QTc intervals	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

Name	Time	Method
mean arteryel pressure	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

Trial Locations

Locations (1)

Duzce Univercity Medical Fauculty; 🇹🇷 Duzce, Turkey