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

NCT ID: NCT02063620

Last Updated: 2019-04-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-10-31
• Study Completion Date: 2014-01-31

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.

Conditions

Qt Interval, Variation in

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

ketamine HCL

%0.5 Lidocaine+Ketamine HCL 0.8 mg/kg, total 40ml, single dose administration, 30 minute duration, total 200mg lidocaine

Group Type: ACTIVE_COMPARATOR

Ketamine HCL

Intervention Type: DRUG

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

lidocaine+ serum physiologic

% 0.5 lidocaine+ serum physiologic, total 40ml, total 200 mg lidocaine, 30 minute duration, single dose administration,

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Ketamine HCL

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

Intervention Type: DRUG

Other Intervention Names

Include brande name: ketalar injectable

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Duzce University

OTHER

Sponsor Role: lead

Responsible Party

Ilknur Suidiye

assistant professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Gokce Akman Kose

Role: PRINCIPAL_INVESTIGATOR

Duzce University School of Medicine

Locations

Duzce Univercity Medical Fauculty

Düzce, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

ilknurseker

Identifier Type: OTHER

Identifier Source: secondary_id

gokceakman

Identifier Type: -

Identifier Source: org_study_id