The Effect of Different Anesthetic Agents Management on Electrocardiographic Changes of Patients Who Were Operated Under Regional Intravenous Anesthesia
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- QT and QTc intervals
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Factorial
- Primary Purpose
- Prevention
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 60 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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,
- •Liver failure,
- •Hypertension,
- •Genetic diseases of musculoskeletal system,
- •Use of antiepileptic drugs, abnormal thyroid functions and operation period over 1 hour.
Arms & Interventions
ketamine HCL
%0.5 Lidocaine+Ketamine HCL 0.8 mg/kg, total 40ml, single dose administration, 30 minute duration, total 200mg lidocaine
Intervention: Ketamine HCL (Drug)
Outcomes
Primary Outcomes
QT and QTc intervals
Time Frame: 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 Outcomes
- mean arteryel pressure(Change of mean arteryel pressure from baseline to 60 minutes)
Investigators
Ilknur Suidiye
assistant professor
Duzce University