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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT00567957
Other study ID # RP01
Secondary ID BYP-1833
Status Not yet recruiting
Phase Phase 4
First received December 4, 2007
Last updated December 4, 2007
Start date February 2008
Est. completion date December 2009

Study information

Verified date December 2007
Source Istanbul University
Contact Tulay Ozkan Seyhan, Associate Prof.
Phone +90 212 631 87 67
Email tulay2000@e-kolay.net
Is FDA regulated No
Health authority Turkey: Ministry of Health
Study type Interventional

Clinical Trial Summary

The purpose of this study is to determine whether remifentanil use in preeclamptic patients may blunt hemodynamic response to intubation during general anesthesia for cesarean section.


Description:

General anesthesia for cesarean section involves rapid sequence induction with a muscle relaxant and barbiturate followed by endotracheal intubation. Although the use of opioids may blunt haemodynamic responses to endotracheal intubation, they are avoided in pregnant patients due to possible respiratory depressants effects on neonates.Preeclamptic patients response with exaggerated sympathoadrenal reflex to anesthesia induction and intubation. The resulting hypertension and tachycardia may result in cerebrovascular accident, pulmonary edema, arrhythmias, increased myocardial oxygen consumption and fetal hypoxia by uterine vasoconstriction. Several drugs have been used to blunt the hemodynamic disturbances to intubation, but none of them have been implicated for routine use for general anesthesia in preeclamptic patients.

Recently remifentanil has started to be used in general anesthesia of high risk obstetric patients. Remifentanil is a μ-opioid receptor agonist that is metabolized by nonspecific blood and tissue esterase hydrolysis. It has a low distribution volume with a context sensitive half life of 3 minutes. Its elimination half life is 12 minutes even after repeated boli. Previously remifentanil use in pregnant patients with cardiac pathology has been reported with minimal neonatal side effects. A randomized controlled study in normal parturient has shown that remifentanil is transferred through placenta and may cause mild neonatal depression that is easily managed. Umbilical artery and vein remifentanil concentrations has shown that remifentanil is quickly redistributed or metabolized in fetus. Thus, remifentanil may be an appropriate drug for induction and maintenance of general anesthesia in severe preeclamptic patients.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 50
Est. completion date December 2009
Est. primary completion date
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 45 Years
Eligibility 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).

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)


Intervention

Drug:
Remifentanil
1 microg/kg iv bolus before induction followed by 0.5 microg/kg/min infusion
Saline
same volume iv bolus before induction followed by same volume infusion

Locations

Country Name City State
Turkey Istanbul University, Istanbul Faculty of Medicine Anesthesiology Dept. Istanbul Capa

Sponsors (1)

Lead Sponsor Collaborator
Istanbul University

Country where clinical trial is conducted

Turkey, 

References & Publications (1)

Ngan Kee WD, Khaw KS, Ma KC, Wong AS, Lee BB, Ng FF. Maternal and neonatal effects of remifentanil at induction of general anesthesia for cesarean delivery: a randomized, double-blind, controlled trial. Anesthesiology. 2006 Jan;104(1):14-20. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Blood pressure Induction to post-intubation period Yes
Secondary Heart rate Induction to delivery Yes
Secondary Amount of additional drugs and fluids if required Induction to delivery Yes
Secondary Evaluation of the newborn Within 10 min following delivery Yes
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