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Remifentanil for General Anesthesia in Preeclamptics

NCT ID: NCT00567957

Last Updated: 2007-12-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-02-29

Study Completion Date

2009-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Pre-Eclampsia Hypertension, Pregnancy-Induced Pregnancy Complications

Keywords

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pre-eclampsia remifentanil anesthesia, general analgesics, opioid anesthetics, intravenous Cesarean section newborn maternal haemodynamic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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C

Saline starting before induction till entry to abdominal cavity

Group Type PLACEBO_COMPARATOR

Saline

Intervention Type DRUG

same volume iv bolus before induction followed by same volume infusion

R

Remifentanil starting before induction till entry to abdominal cavity

Group Type ACTIVE_COMPARATOR

Remifentanil

Intervention Type DRUG

1 microg/kg iv bolus before induction followed by 0.5 microg/kg/min infusion

Interventions

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Remifentanil

1 microg/kg iv bolus before induction followed by 0.5 microg/kg/min infusion

Intervention Type DRUG

Saline

same volume iv bolus before induction followed by same volume infusion

Intervention Type DRUG

Other Intervention Names

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Ultiva % 0.9 NaCl

Eligibility 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).
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Istanbul University

OTHER

Sponsor Role lead

Responsible Party

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Istanbul University- Istanbul Faculty of Medicine, Dept. of Anesthesiology

Principal Investigators

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Tulay Ozkan Seyhan, Associate Prof

Role: PRINCIPAL_INVESTIGATOR

Istanbul University

Locations

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Istanbul University, Istanbul Faculty of Medicine Anesthesiology Dept.

Istanbul, Capa, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Central Contacts

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Tulay Ozkan Seyhan, Associate Prof.

Role: CONTACT

Phone: +90 212 631 87 67

Email: [email protected]

Mukadder Orhan Sungur, Staff

Role: CONTACT

Phone: +90 212 631 87 67

Email: [email protected]

References

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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. doi: 10.1097/00000542-200601000-00004.

Reference Type BACKGROUND
PMID: 16394684 (View on PubMed)

Other Identifiers

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BYP-1833

Identifier Type: -

Identifier Source: secondary_id

RP01

Identifier Type: -

Identifier Source: org_study_id