Comparison Between Ondansetron 8 mg and Lidocain 40 mg in Preventing Pain Due to Propofol Injection
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Indonesia University
- Enrollment
- 104
- Locations
- 1
- Primary Endpoint
- The Degree of pain due to Propofol Injection
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Double (Participant, Care Provider)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Ondansetron
Ondansetron 8mg (2mg/cc) was given intravenously via a 20 G vein canula
Intervention: Ondansetron 8 mg (Drug)
Lidocain
Lidocain 40mg (20mg/cc + 2cc of normal saline) was given intravenously via a 20 G vein canula
Intervention: Lidocain 40 mg (Drug)
Outcomes
Primary Outcomes
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
Secondary Outcomes
No secondary outcomes reported
Investigators
Aries Perdana
Consultant, Anesthesiologist
Indonesia University