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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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29 April 2024 |
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Main ID: |
NCT01871922 |
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Date of registration:
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30/05/2013 |
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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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Atropine-effect During Propofol/Remifentanil Induction
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Scientific title:
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Evaluation of the Effects of the Addition of Atropine During Propofol/Remifentanil Induction of Anesthesia on Hemodynamics, Microvascular Blood Flow and Tissue Oxygenenation in Patients Undergoing Ophthalmic Surgery |
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Date of first enrolment:
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October 2012 |
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Target sample size:
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60 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/ct2/show/NCT01871922 |
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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: Single Group Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
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Phase:
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N/A
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Countries of recruitment
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Netherlands
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Contacts
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Name:
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Alain F Kalmar, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University Medical Center Groningen |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Patients requiring general anaesthesia;
- Patient's age = 18 years and older;
- Patient and surgical procedure appropriate for treatment with either sufentanil or
remifentanil.
Exclusion Criteria:
- Patient's refusal;
- Pregnancy;
- Patient's age < 18 years;
- Patients in which atropine is contra-indicated, such as severe aortic valve stenosis,
hypertrophic cardiomyopathy or coronary artery disease.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Anesthesia-induced Negative Hemodynamic Effects
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Intervention(s)
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Drug: Atropine
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Drug: Placebo
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Primary Outcome(s)
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Cardiac output
[Time Frame: During anesthesia]
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Cerebral tissue oxygen saturation
[Time Frame: During anesthesia]
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Peripheral tissue oxygen saturation
[Time Frame: During anesthesia]
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Secondary Outcome(s)
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Mean arterial blood pressure
[Time Frame: During anesthesia]
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Heart rate
[Time Frame: During anesthesia]
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Systemic vascular resistance
[Time Frame: During anesthesia]
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Secondary ID(s)
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Retro-002
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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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