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

Study Overview
=================
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.

Official Title
-----------------
The Effect of Different Anesthetic Agents Management on Electrocardiographic Changes of Patients Who Were Operated Under Regional Intravenous Anesthesia

Conditions
-----------------
Qt Interval, Variation in

Intervention / Treatment
-----------------
* Drug: Ketamine HCL


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients between 18-60 years ASA 1-2 physical status Undergoing IVRA for short operations on arm and forearm Exclusion Criteria: Allergy to study drugs, Serious cardiac diseases, Respiratory diseases, Renal failure, Drug addiction, Pregnancy, Liver failure, Hypertension, Genetic diseases of musculoskeletal system, Use of antiepileptic drugs, abnormal thyroid functions and operation period over 1 hour.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: ketamine HCL<br>%0.5 Lidocaine+Ketamine HCL 0.8 mg/kg, total 40ml, single dose administration, 30 minute duration, total 200mg lidocaine | Drug: Ketamine HCL<br>* ketamine HCL is using as adjuvant agent with local anesthetic agent in regional intravenous anesthesia procedure routinely<br>* Other names: Include brande name: ketalar injectable;|
| No Intervention: lidocaine+ serum physiologic<br>% 0.5 lidocaine+ serum physiologic, total 40ml, total 200 mg lidocaine, 30 minute duration, single dose administration, | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Change QT and QTc intervals from baseline to 60 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mean arteryel pressure | 0,5,10,15,30,45,60 minutes after the beginning of deflation and 10 minutes after the deflation was completed | Change of mean arteryel pressure from baseline to 60 minutes | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
IVRA, ketamine, lidocaine, ECG