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Completed

NCT Number: NCT03134612

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

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

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Cipto Mangunkusumo Central National Hospital

Jakarta, DKI Jakarta, 10430, Indonesia

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Ondansetron 8 mg

Drug

Lidocain 40 mg

Drug

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Indonesia University

Other

Registry information

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
May 1, 2017
Registry last updated
May 1, 2017

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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