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

General Anesthesia With Propofol Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03134612
• Other study ID #: IndonesiaUAnes005
• Status: Completed
• Phase: Phase 2
• First received: April 24, 2017
• Last updated: April 26, 2017
• Start date: July 2016
• Est. completion date: September 2016

Study information

• Verified date: April 2017
• Source: Indonesia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 104
• Est. completion date: September 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• General Anesthesia With Propofol

Intervention

Drug:
• Ondansetron 8 mg

• Lidocain 40 mg

Locations

Country	Name	City	State
Indonesia	Cipto Mangunkusumo Central National Hospital	Jakarta	DKI Jakarta

Sponsors (1)

Lead Sponsor	Collaborator
Indonesia University

Country where clinical trial is conducted

Indonesia, 

References & Publications (35)

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* Note: There are 35 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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