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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: ClinicalTrials.gov
Last refreshed on: 19 February 2015
Main ID:  NCT00567957
Date of registration: 04/12/2007
Prospective Registration: Yes
Primary sponsor: Istanbul University
Public title: Remifentanil for General Anesthesia in Preeclamptics
Scientific title: Remifentanil for c-Section With General Anesthesia in Severe Preeclamptic Patients
Date of first enrolment: February 2008
Target sample size: 50
Recruitment status: Not yet recruiting
URL:  http://clinicaltrials.gov/show/NCT00567957
Study type:  Interventional
Study design:  Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)  
Phase:  Phase 4
Countries of recruitment
Turkey
Contacts
Name:     Tulay Ozkan Seyhan, Associate Prof
Address: 
Telephone:
Email:
Affiliation:  Istanbul University, Istanbul Faculty of Medicine
Name:     Tulay Ozkan Seyhan, Associate Prof.
Address: 
Telephone: +90 212 631 87 67
Email: tulay2000@e-kolay.net
Affiliation: 
Key inclusion & exclusion criteria

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
Health Condition(s) or Problem(s) studied
Pre-Eclampsia
Pregnancy Complications
Hypertension, Pregnancy-Induced
Intervention(s)
Drug: Saline
Drug: Remifentanil
Primary Outcome(s)
Blood pressure [Time Frame: Induction to post-intubation period]
Secondary Outcome(s)
Heart rate [Time Frame: Induction to delivery]
Amount of additional drugs and fluids if required [Time Frame: Induction to delivery]
Evaluation of the newborn [Time Frame: Within 10 min following delivery]
Secondary ID(s)
RP01
BYP-1833
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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