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Completed

NCT Number: NCT02063620

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

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.

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Key information

Conditions

Qt Interval, Variation in

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Duzce Univercity Medical Fauculty

Düzce, 81600, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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,
  • Pregnancy,
  • Liver failure,
  • Hypertension,
  • Genetic diseases of musculoskeletal system,
  • Use of antiepileptic drugs, abnormal thyroid functions and operation period over 1 hour.

Treatment and study plan

Ketamine HCL

Drug

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

Other names: Include brande name: ketalar injectable

Primary outcomes

  1. 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

  1. mean arteryel pressure

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Duzce University

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Feb 14, 2014
Registry last updated
Apr 22, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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