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

Phase 2

Completed

• Conditions: General Anesthesia With Propofol
• Interventions: Drug: Lidocain 40 mg; Drug: Ondansetron 8 mg

• Registration Number: NCT03134612
• Lead Sponsor: Indonesia University

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 Timeline

• Study Start: 2016-07
• Primary Completion: 2016-09
• Study Completion: 2016-09
• Status Verified: 2017-04
• Study First Submitted: 2017-04-24
• Study First Submitted QC: 2017-04-26
• Last Update Submitted: 2017-04-26
• Study First Posted: 2017-05-01
• Last Update Posted: 2017-05-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 104

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lidocain	Lidocain 40 mg	Lidocain 40mg (20mg/cc + 2cc of normal saline) was given intravenously via a 20 G vein canula
Ondansetron	Ondansetron 8 mg	Ondansetron 8mg (2mg/cc) was given intravenously via a 20 G vein canula

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Cipto Mangunkusumo Central National Hospital; 🇮🇩 Jakarta, DKI Jakarta, Indonesia