Remifentanil for General Anesthesia in Preeclamptics

Study Overview
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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.

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

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

Intervention / Treatment
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* Drug: Remifentanil
* Drug: Saline


Participation Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: C<br>Saline starting before induction till entry to abdominal cavity | Drug: Saline<br>* same volume iv bolus before induction followed by same volume infusion<br>* Other names: % 0.9 NaCl;|
| Active Comparator: R<br>Remifentanil starting before induction till entry to abdominal cavity | Drug: Remifentanil<br>* 1 microg/kg iv bolus before induction followed by 0.5 microg/kg/min infusion<br>* Other names: Ultiva;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood pressure |  | Induction to post-intubation period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Heart rate |  | Induction to delivery | 
| Amount of additional drugs and fluids if required |  | Induction to delivery | 
| Evaluation of the newborn |  | Within 10 min following delivery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pre-eclampsia, remifentanil, anesthesia, general, analgesics, opioid, anesthetics, intravenous, Cesarean section, newborn, maternal haemodynamic