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

Sponsor

Indonesia University (Other)

Overall Status

Completed

CT.gov ID

NCT03134612

Collaborator

(none)

104

Enrollment

Location

Arms

Actual Duration (Months)

51.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
General Anesthesia With Propofol	Drug: Ondansetron 8 mg Drug: Lidocain 40 mg	Phase 2

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

Actual Enrollment :

104 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Care Provider)

Primary Purpose:

Supportive Care

Official Title:

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

Actual Study Start Date :

Jul 1, 2016

Actual Primary Completion Date :

Sep 1, 2016

Actual Study Completion Date :

Sep 1, 2016

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts 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.