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

NCT03134612 | Completed Phase 2

• 1 other identifier: IndonesiaUAnes005
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

General Anesthesia With Propofol

Keywords

lidocain; ondansetron; pain; propofol

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Ondansetron

ACTIVE COMPARATOR

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

Drug: Ondansetron 8 mg

Lidocain

ACTIVE COMPARATOR

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

Drug: Lidocain 40 mg

Interventions

Ondansetron 8 mg DRUG

Ondansetron

Lidocain 40 mg DRUG

Lidocain

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Indonesia University: lead

Study Sites (1)

Cipto Mangunkusumo Central National Hospital

Jakarta, DKI Jakarta, 10430, Indonesia

Location

Related Publications (35)

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MeSH Terms

Conditions

Pain

Interventions

Ondansetron

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Carbazoles; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds, 3-Ring

Study Officials

• Aries Perdana, Consultant

  Indonesia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant, Anesthesiologist

Study Record Dates

• First Submitted: April 24, 2017
• First Posted: May 1, 2017
• Study Start: July 1, 2016
• Primary Completion: September 1, 2016
• Study Completion: September 1, 2016
• Last Updated: May 1, 2017

Record last verified: 2017-04

Locations

ID (1)