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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02063620

Enrollment

Registered

2014-02-14

Start date

2013-10-31

Completion date

2014-01-31

Last updated

2019-04-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Qt Interval, Variation in

Keywords

IVRA, ketamine, lidocaine, ECG

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.

Interventions

DRUGKetamine HCL

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

Study design

Allocation

RANDOMIZED

Intervention model

FACTORIAL

Primary purpose

PREVENTION

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026