Remifentanil for General Anesthesia in Preeclamptics

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

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.

Study Overview

• Status: Unknown
• Conditions: Pregnancy Complications; Pre-Eclampsia; Hypertension, Pregnancy-Induced
• Intervention / Treatment: Drug: Saline; Drug: Remifentanil

Detailed 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.

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Phase 4

Contacts and Locations

Study Locations

• Turkey
  • Capa
    • Istanbul, Capa, Turkey, 34390
      • Istanbul University, Istanbul Faculty of Medicine Anesthesiology Dept.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Istanbul University
• Investigators: Principal Investigator: Tulay Ozkan Seyhan, Associate Prof, Istanbul University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: February 1, 2008
• Study Completion (Anticipated): December 1, 2009

Study Registration Dates

• First Submitted: December 4, 2007
• First Submitted That Met QC Criteria: December 4, 2007
• First Posted (Estimate): December 5, 2007

Study Record Updates

• Last Update Posted (Estimate): December 5, 2007
• Last Update Submitted That Met QC Criteria: December 4, 2007
• Last Verified: December 1, 2007

More Information

Terms related to this study

• Keywords: Cesarean section; newborn; remifentanil; pre-eclampsia; anesthesia, general; analgesics, opioid; anesthetics, intravenous; maternal haemodynamic
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension; Eclampsia; Pre-Eclampsia; Pregnancy Complications; Hypertension, Pregnancy-Induced; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Opioid; Narcotics; Remifentanil
• Other Study ID Numbers: RP01; BYP-1833