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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03134612

Enrollment

104

Registered

2017-05-01

Start date

2016-07-31

Completion date

2016-09-30

Last updated

2017-05-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

General Anesthesia With Propofol

Keywords

lidocain, ondansetron, pain, propofol

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.

Interventions

DRUGOndansetron 8 mg

DRUGLidocain 40 mg

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

DOUBLE (Subject, Caregiver)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

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.

Design outcomes

Primary

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

Countries

Indonesia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026