Comparison Between Ondansetron 8 mg and Lidocain 40 mg in Preventing Pain Due to Propofol Injection

April 26, 2017 updated by: Aries Perdana, Indonesia University
This study aims to compare the effectivity between ondansetron 8 mg and lidocain 40 mg in preventing pain due to propofol injection

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Approval from Ethical Committee of Faculty of Medicine Universitas Indonesia was acquired prior conducting the study. Subjects were given informed consent before enrolling the study. Non-invasive blood pressure (NIBP) monitor, ECG and pulse-oximeter was set on the subjects in the operation room. After a tourniquet made from NIBP cuff were inflated, subjects were given either Ondansetron 8 mg or Lidocain 20 mg intravenously, then the tourniquet was set off. Hemodynamic data was recorded. Propofol 1 mg/kg of body weight (BW) injection was given. Verbal rating scale was used to measure pain at 0 s, 5 s and 30 s. Data was analyzed using Statistical Package for the Social Sciences (SPSS), for numeric data using uni-variate analysis and bi-variate analysis. Significant value is p<0.05.

Study Type

Interventional

Enrollment (Actual)

104

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Indonesia
    • DKI Jakarta
      • Jakarta, DKI Jakarta, Indonesia, 10430
        • Cipto Mangunkusumo Central National Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Subjects aged 18-65 years old
  • Subjects were planned to undergo general anesthesia with propofol
  • Subjects with Body Mass Index (BMI) 18-35 kg/m2
  • Subjects with American Society of Anesthesiologists (ASA) physical status of I-II
  • Subjects with signed informed consent.

Exclusion Criteria:

  • Subjects with allergies to propofol, lidocain, ondansetron
  • Subjects with massive cardiac disorder
  • Subjects with cardiac rhythm disorder with or without treatment
  • Subjects with unstable hemodynamic
  • Subjects with contraindication to propofol, lidocain, ondansetron
  • Subjects with intubation and ventilation difficulty
  • Subjects with decreased consciousness, seizure history or head injury
  • Subjects with analgesic treatment history
  • Subjects with pregnancy.

Drop out criteria:

  • Subjects with allergic reactions induced by propofol, lidocain, ondansetron
  • Uncooperative subjects
  • Subjects in emergency
  • Subjects with difficult vein access in the dorsum manus
  • Subjects with infection and/or inflammation in the planned intravenous cannulation location.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Ondansetron
Ondansetron 8mg (2mg/cc) was given intravenously via a 20 G vein canula
Drug: Ondansetron 8 mg
Active Comparator: Lidocain
Lidocain 40mg (20mg/cc + 2cc of normal saline) was given intravenously via a 20 G vein canula
Drug: Lidocain 40 mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Degree of pain due to Propofol Injection
Time Frame: Day 1
The degree of pain due to propofol injection was measured at 0 second, 15 seconds, 30 second, using verbal rating scale
Day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Indonesia University

Investigators

  • Principal Investigator: Aries Perdana, Consultant, Indonesia University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2016

Primary Completion (Actual)

September 1, 2016

Study Completion (Actual)

September 1, 2016

Study Registration Dates

First Submitted

April 24, 2017

First Submitted That Met QC Criteria

April 26, 2017

First Posted (Actual)

May 1, 2017

Study Record Updates

Last Update Posted (Actual)

May 1, 2017

Last Update Submitted That Met QC Criteria

April 26, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IndonesiaUAnes005

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Study Data/Documents

  1. Textbook
    Information comments: Assessment and measurement of pain and its treatment. In: Macintyre PE SD, Schug SA, Visser EJ, Walker SM, editors. Acute pain management: scientific evidence. Melbourne: Australian and New Zealand College of Anaesthetists and Faculty of Pain Medicine; 2010.p. 35-43

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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