Clinical trial NCT03134612: Comparison Between Ondansetron 8 mg and Lidocain 40 mg in Preventing Pain Due to Propofol Injection
Official title: Comparison Between Ondansetron 8 mg and Lidocain 40 mg in Preventing Pain Due to Propofol Injection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: General Anesthesia With Propofol
Keywords: lidocain
ondansetron
pain
propofol
Lead sponsor: Indonesia University
Sponsor class: OTHER
First posted: 2017-05-01
Enrollment: 104
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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.

Primary outcomes:
measure: The Degree of pain due to Propofol Injection
timeFrame: Day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Jakarta
country: Indonesia
facility: Cipto Mangunkusumo Central National Hospital
state: DKI Jakarta
Study officials:
affiliation: Indonesia University
name: Aries Perdana, Consultant
role: PRINCIPAL_INVESTIGATOR
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