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. |
Register:
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ClinicalTrials.gov |
Last refreshed on:
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19 February 2015 |
Main ID: |
NCT00567957 |
Date of registration:
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04/12/2007 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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Remifentanil for General Anesthesia in Preeclamptics
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Scientific title:
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Remifentanil for c-Section With General Anesthesia in Severe Preeclamptic Patients |
Date of first enrolment:
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February 2008 |
Target sample size:
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50 |
Recruitment status: |
Not yet recruiting |
URL:
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http://clinicaltrials.gov/show/NCT00567957 |
Study type:
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Interventional |
Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, 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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Turkey
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Contacts
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Name:
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Tulay Ozkan Seyhan, Associate Prof |
Address:
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Telephone:
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Email:
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Affiliation:
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Istanbul University, Istanbul Faculty of Medicine |
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Name:
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Tulay Ozkan Seyhan, Associate Prof. |
Address:
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Telephone:
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+90 212 631 87 67 |
Email:
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tulay2000@e-kolay.net |
Affiliation:
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Severe preeclamptic parturients with single fetus pregnancy with contraindication to
regional anesthesia
Exclusion Criteria:
- Known allergy to study drugs
- Known fetal anomaly and /or gestation week and /or estimated to be nonviable (fetal
weight <400 gr, gestational week<24 weeks)
- Known cardiac disease diagnosed prior to pregnancy
- Known drug abuse in the parturient
- Multifetal gestation
- Anticipated difficult airway management (mask ventilation and/or endotracheal
intubation).
Age minimum:
18 Years
Age maximum:
45 Years
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Pre-Eclampsia
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Pregnancy Complications
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Hypertension, Pregnancy-Induced
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Intervention(s)
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Drug: Saline
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Drug: Remifentanil
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Primary Outcome(s)
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Blood pressure
[Time Frame: Induction to post-intubation period]
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Secondary Outcome(s)
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Heart rate
[Time Frame: Induction to delivery]
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Amount of additional drugs and fluids if required
[Time Frame: Induction to delivery]
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Evaluation of the newborn
[Time Frame: Within 10 min following delivery]
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Secondary ID(s)
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RP01
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BYP-1833
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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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