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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: |
NCT03251222 |
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Date of registration:
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02/08/2017 |
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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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Intranasal Sedation With Dexmedetomidine
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Scientific title:
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Intranasal Sedation With Dexmedetomidine for Vitroretinal Procedures |
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Date of first enrolment:
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January 1, 2017 |
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Target sample size:
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40 |
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Recruitment status: |
Recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT03251222 |
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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: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
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Phase:
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Phase 4
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Countries of recruitment
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Slovenia
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Contacts
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Name:
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Vesna Novak Jankovic, MD, PROF |
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Address:
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Telephone:
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+38615222930 |
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Email:
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vnovakjankovic@gmail.com |
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Affiliation:
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Name:
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Vesna Novak-Jankovic, PROF |
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Address:
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Telephone:
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Email:
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Affiliation:
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UMCLjubljana, KOAIT |
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Name:
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Iztok Potocnik, PHD |
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Address:
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Telephone:
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0038615228191 |
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Email:
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iztokpotocnik@gmail.com |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion Criteria: patients who will be operated on the eye (vitreoretinal interventions)
patients with ASA status 1-3
Exclusion Criteria:
- patients who will not want to be operated in the sedation but in general anesthesia
- poor general condition (ASA> 3)
- with severe cardiac disease (NYHA> 3)
- with severe pulmonary obstructive disease (FEV1 <40%)
- neurological diseases
- psychiatric patients
- patients receiving regular psychotropic treatment
Age minimum:
18 Years
Age maximum:
70 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Conscious Sedation
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Intervention(s)
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Drug: Dexmedetomidine
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Other: Placebo - Concentrate
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Primary Outcome(s)
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remifentanil consuption
[Time Frame: duration of the procedure]
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Secondary Outcome(s)
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Oxigen Saturation
[Time Frame: duration of the procedure]
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Secondary ID(s)
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UKC-OCKL1
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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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