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

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

Detailed Description
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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.

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

Conditions
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General Anesthesia With Propofol

Intervention / Treatment
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* Drug: Ondansetron 8 mg
* Drug: Lidocain 40 mg


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Ondansetron<br>Ondansetron 8mg (2mg/cc) was given intravenously via a 20 G vein canula | Drug: Ondansetron 8 mg<br> <br> |
| Active Comparator: Lidocain<br>Lidocain 40mg (20mg/cc + 2cc of normal saline) was given intravenously via a 20 G vein canula | Drug: Lidocain 40 mg<br> <br> |

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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lidocain, ondansetron, pain, propofol