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

Qt Interval, Variation in Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02063620
• Other study ID #: gokceakman
• Secondary ID: ilknurseker
• Status: Completed
• Phase: N/A
• Start date: October 2013
• Est. completion date: January 2014

Study information

• Verified date: April 2019
• Source: Duzce University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: January 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Qt Interval, Variation in

Intervention

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

Locations

Country	Name	City	State
Turkey	Duzce Univercity Medical Fauculty	Duzce

Sponsors (1)

Lead Sponsor	Collaborator
Duzce University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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