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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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12 December 2020 |
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Main ID: |
NCT03037892 |
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Date of registration:
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24/08/2015 |
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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 of Remifentanil as a Sole Agent or in Combination With Midazolam Versus Fentanyl/Midazolam During Sedation for Colonoscopy
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Scientific title:
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A Prospective Randomized Comparative Study to Evaluate the Use of Remifentanil as a Sole Agent or in Combination With Midazolam Versus Fentanyl/Midazolam During Sedation for Colonoscopy |
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Date of first enrolment:
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June 1, 2015 |
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Target sample size:
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75 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT03037892 |
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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: Treatment. Masking: Single (Participant).
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Phase:
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N/A
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Countries of recruitment
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Bahrain
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Contacts
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Name:
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Reeta Singh, MD DNBE MBA |
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Address:
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Telephone:
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Email:
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Affiliation:
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Awali Hospital |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. Patients between 18-75 years
2. ASA Grade I, II and controlled ASA III.
Exclusion Criteria:
1. Patient Refusal
2. Patients with psychiatric or Emotional Disorders
3. Previous adverse reaction to any of the drugs used
4. History of addiction to opiates/sedatives/alcohol
5. ASA Grade 3-4 patients with clinically significant or uncontrolled cardiovascular or
respiratory disease.
6. Pregnancy
7. Age <=18years
Age minimum:
18 Years
Age maximum:
75 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Colonoscopy
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Intervention(s)
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Drug: Midazolam, Fentanyl
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Drug: Midazolam, Remifentanil
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Drug: Remifentanil
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Primary Outcome(s)
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The Recovery Time
[Time Frame: 30 min]
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propofol consumption
[Time Frame: 60 minutes]
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Secondary Outcome(s)
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Endoscopist Satisfaction
[Time Frame: 60 min]
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Side effects
[Time Frame: 6 hours]
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Patient satisfaction
[Time Frame: 6 hours]
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Incidence of Patient's Recall.
[Time Frame: 6 hours]
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Secondary ID(s)
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KHUH/Research/No.89/2015
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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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