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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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16 December 2017 |
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Main ID: |
NCT03134612 |
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Date of registration:
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24/04/2017 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Comparison Between Ondansetron 8 mg and Lidocain 40 mg in Preventing Pain Due to Propofol Injection
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Scientific title:
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Comparison Between Ondansetron 8 mg and Lidocain 40 mg in Preventing Pain Due to Propofol Injection |
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Date of first enrolment:
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July 2016 |
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Target sample size:
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104 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT03134612 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Supportive Care. Masking: Double (Participant, Care Provider).
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Phase:
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Phase 2
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Countries of recruitment
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Indonesia
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Contacts
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Name:
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Aries Perdana, Consultant |
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Address:
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Telephone:
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Email:
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Affiliation:
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Indonesia University |
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Key inclusion & exclusion criteria
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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.
Age minimum:
18 Years
Age maximum:
65 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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General Anesthesia With Propofol
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Intervention(s)
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Drug: Ondansetron 8 mg
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Drug: Lidocain 40 mg
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Primary Outcome(s)
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The Degree of pain due to Propofol Injection
[Time Frame: Day 1]
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Secondary ID(s)
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IndonesiaUAnes005
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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