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

NCT02063620 | Completed

• 2 other identifiers: gokceakmanilknurseker
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Qt Interval, Variation in

Keywords

IVRA, ketamine, lidocaine, ECG

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• mean arteryel pressure

  Change of mean arteryel pressure from baseline to 60 minutes

Study Arms (2)

ketamine HCL

ACTIVE COMPARATOR

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

Drug: Ketamine HCL

lidocaine+ serum physiologic

NO INTERVENTION

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

Interventions

Ketamine HCL DRUG

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

Also known as: Include brande name: ketalar injectable

ketamine HCL

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Patients between 18-60 years
• ASA 1-2 physical status
• Undergoing IVRA for short operations on arm and forearm

You may not qualify if:

• Allergy to study drugs,
• Serious cardiac diseases,
• Respiratory diseases,
• Renal failure,
• Drug addiction,
• Pregnancy,
• Liver failure,
• Hypertension,
• Genetic diseases of musculoskeletal system,
• Use of antiepileptic drugs, abnormal thyroid functions and operation period over 1 hour.

Sponsors & Collaborators

• Duzce University: lead

Study Sites (1)

Duzce Univercity Medical Fauculty

Düzce, 81600, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Ketamine

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Gokce Akman Kose

  Duzce University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant professor

Study Record Dates

• First Submitted: January 29, 2014
• First Posted: February 14, 2014
• Study Start: October 1, 2013
• Primary Completion: January 1, 2014
• Study Completion: January 1, 2014
• Last Updated: April 22, 2019

Record last verified: 2019-04

Locations

TU (1)