Remifentanil for General Anesthesia in Preeclamptics

Pre-Eclampsia Clinical Trial

Official title:

Remifentanil for c-Section With General Anesthesia in Severe Preeclamptic Patients

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
• 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)

Related Conditions & MeSH terms

• Eclampsia
• Hypertension, Pregnancy-Induced
• Pre-Eclampsia
• Pregnancy Complications

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