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

NCT ID: NCT03134612

Last Updated: 2017-05-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 104 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-07-31
• Study Completion Date: 2016-09-30

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.

Conditions

General Anesthesia With Propofol

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

Ondansetron

Ondansetron 8mg (2mg/cc) was given intravenously via a 20 G vein canula

Group Type: ACTIVE_COMPARATOR

Ondansetron 8 mg

Intervention Type: DRUG

Lidocain

Lidocain 40mg (20mg/cc + 2cc of normal saline) was given intravenously via a 20 G vein canula

Group Type: ACTIVE_COMPARATOR

Lidocain 40 mg

Intervention Type: DRUG

Interventions

Ondansetron 8 mg

Intervention Type: DRUG

Lidocain 40 mg

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Indonesia University

OTHER

Sponsor Role: lead

Responsible Party

Aries Perdana

Consultant, Anesthesiologist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Aries Perdana, Consultant

Role: PRINCIPAL_INVESTIGATOR

Indonesia University

Locations

Cipto Mangunkusumo Central National Hospital

Jakarta, DKI Jakarta, Indonesia

Countries

Indonesia

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Study Documents

Document Type: Textbook

Assessment and measurement of pain and its treatment. In: Macintyre PE SD, Schug SA, Visser EJ, Walker SM, editors. Acute pain management: scientific evidence. Melbourne: Australian and New Zealand College of Anaesthetists and Faculty of Pain Medicine; 2010.p. 35-43

View Document

Document Type: Textbook

Candido KD, Winnie AP. Intravenous regional block for upper \& lower extremity surgery. In: Hadzic A, editor. Textbook of regional anesthesia and acute pain management. New York: McGraw-Hill; 2007. p. 565-78

View Document

Other Identifiers

IndonesiaUAnes005

Identifier Type: -

Identifier Source: org_study_id