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

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

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.

Study Overview

• Status: Completed
• Conditions: Qt Interval, Variation in
• Intervention / Treatment: Drug: Ketamine HCL

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 Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Duzce, Turkey, 81600
    • Duzce Univercity Medical Fauculty

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: 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,

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

Collaborators and Investigators

• Sponsor: Duzce University
• Investigators: Principal Investigator: Gokce Akman Kose, Duzce University School of Medicine

Study record dates

Study Major Dates

• Study Start: October 1, 2013
• Primary Completion (Actual): January 1, 2014
• Study Completion (Actual): January 1, 2014

Study Registration Dates

• First Submitted: January 29, 2014
• First Submitted That Met QC Criteria: February 13, 2014
• First Posted (Estimate): February 14, 2014

Study Record Updates

• Last Update Posted (Actual): April 22, 2019
• Last Update Submitted That Met QC Criteria: April 19, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Keywords: IVRA, ketamine, lidocaine, ECG
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Dissociative; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Excitatory Amino Acid Antagonists; Excitatory Amino Acid Agents; Ketamine
• Other Study ID Numbers: gokceakman; ilknurseker (Other Identifier: Duzce University)