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Clinical Trials/NCT03134612
NCT03134612CompletedPhase 2

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

Indonesia University1 site in 1 country104 target enrollmentStarted: July 2016Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 2
Status
Completed
Enrollment
104
Locations
1
Primary Endpoint
The Degree of pain due to Propofol Injection

Study Overview

Brief Summary

This study aims to compare the effectivity between ondansetron 8 mg and lidocain 40 mg in preventing pain due to propofol injection

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Supportive Care
Masking
Double (Participant, Care Provider)

Eligibility Criteria

Ages
18 Years to 65 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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.

Arms & Interventions

Ondansetron

Active Comparator

Ondansetron 8mg (2mg/cc) was given intravenously via a 20 G vein canula

Intervention: Ondansetron 8 mg (Drug)

Lidocain

Active Comparator

Lidocain 40mg (20mg/cc + 2cc of normal saline) was given intravenously via a 20 G vein canula

Intervention: Lidocain 40 mg (Drug)

Outcomes

Primary Outcomes

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

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Aries Perdana

Consultant, Anesthesiologist

Indonesia University

Study Sites (1)

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