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

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ClinicalTrials.gov Identifier: NCT03134612
Recruitment Status : Completed
First Posted : May 1, 2017
Last Update Posted : May 1, 2017
Sponsor:
Information provided by (Responsible Party):
Aries Perdana, Indonesia University

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

Condition or disease Intervention/treatment Phase
General Anesthesia With Propofol Drug: Ondansetron 8 mg Drug: Lidocain 40 mg Phase 2

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 104 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Supportive Care
Official Title: Comparison Between Ondansetron 8 mg and Lidocain 40 mg in Preventing Pain Due to Propofol Injection
Actual Study Start Date : July 2016
Actual Primary Completion Date : September 2016
Actual Study Completion Date : September 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Ondansetron
Ondansetron 8mg (2mg/cc) was given intravenously via a 20 G vein canula
Drug: Ondansetron 8 mg
Active Comparator: Lidocain
Lidocain 40mg (20mg/cc + 2cc of normal saline) was given intravenously via a 20 G vein canula
Drug: Lidocain 40 mg



Primary Outcome Measures :
  1. 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



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03134612


Locations
Indonesia
Cipto Mangunkusumo Central National Hospital
Jakarta, DKI Jakarta, Indonesia, 10430
Sponsors and Collaborators
Indonesia University
Investigators
Principal Investigator: Aries Perdana, Consultant Indonesia University

Study Data/Documents: Textbook  This link exits the ClinicalTrials.gov site
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
Textbook  This link exits the ClinicalTrials.gov site
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
Textbook  This link exits the ClinicalTrials.gov site
Butterworth JF, Wasnick JD. Adjuncts to anesthesia. In: Butterworth JF, Wasnick JD, editors. Morgan & Mikhail's Clinical Anesthesiology. New York: McGraw-Hill; 2013. p. 277-93
Textbook  This link exits the ClinicalTrials.gov site
Sanders-Bush E HL. 5-Hydroxytryptamine (Serotonin) and Dopamin. In: Brunton L CB, Knollman B, editors. Goodman and Giman's The Pharmacological Basis of Therapeutics. New York: McGraw-Hill; 2011

Publications:

Responsible Party: Aries Perdana, Consultant, Anesthesiologist, Indonesia University
ClinicalTrials.gov Identifier: NCT03134612     History of Changes
Other Study ID Numbers: IndonesiaUAnes005
First Posted: May 1, 2017    Key Record Dates
Last Update Posted: May 1, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Aries Perdana, Indonesia University:
lidocain
ondansetron
pain
propofol

Additional relevant MeSH terms:
Lidocaine
Propofol
Ondansetron
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Hypnotics and Sedatives
Anesthetics, Intravenous
Anesthetics, General
Antiemetics
Autonomic Agents
Gastrointestinal Agents
Antipruritics
Dermatologic Agents
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Antipsychotic Agents
Tranquilizing Agents
Psychotropic Drugs
Anti-Anxiety Agents