Remifentanil for General Anesthesia in Preeclamptics
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Pre-Eclampsia Hypertension, Pregnancy-Induced Pregnancy Complications |
Drug: Remifentanil Drug: Saline |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) |
| Official Title: | Remifentanil for c-Section With General Anesthesia in Severe Preeclamptic Patients |
- Blood pressure [ Time Frame: Induction to post-intubation period ] [ Designated as safety issue: Yes ]
- Heart rate [ Time Frame: Induction to delivery ] [ Designated as safety issue: Yes ]
- Amount of additional drugs and fluids if required [ Time Frame: Induction to delivery ] [ Designated as safety issue: Yes ]
- Evaluation of the newborn [ Time Frame: Within 10 min following delivery ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 50 |
| Study Start Date: | February 2008 |
| Estimated Study Completion Date: | December 2009 |
| Arms | Assigned Interventions |
|---|---|
|
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 Name: % 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 Name: Ultiva
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 45 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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).
Contacts and Locations| Contact: Tulay Ozkan Seyhan, Associate Prof. | +90 212 631 87 67 | tulay2000@e-kolay.net |
| Contact: Mukadder Orhan Sungur, Staff | +90 212 631 87 67 | mosungur@istanbul.edu.tr |
| Turkey | |
| Istanbul University, Istanbul Faculty of Medicine Anesthesiology Dept. | Not yet recruiting |
| Istanbul, Capa, Turkey, 34390 | |
| Principal Investigator: | Tulay Ozkan Seyhan, Associate Prof | Istanbul University, Istanbul Faculty of Medicine |
More Information
Publications:
| Responsible Party: | Tulay Ozkan Seyhan, Istanbul University- Istanbul Faculty of Medicine, Dept. of Anesthesiology |
| ClinicalTrials.gov Identifier: | NCT00567957 History of Changes |
| Other Study ID Numbers: | RP01, BYP-1833 |
| Study First Received: | December 4, 2007 |
| Last Updated: | December 4, 2007 |
| Health Authority: | Turkey: Ministry of Health |
Keywords provided by Istanbul University:
|
pre-eclampsia remifentanil anesthesia, general analgesics, opioid |
anesthetics, intravenous Cesarean section newborn maternal haemodynamic |
Additional relevant MeSH terms:
|
Eclampsia Hypertension Pre-Eclampsia Pregnancy Complications Hypertension, Pregnancy-Induced Vascular Diseases Cardiovascular Diseases Anesthetics Remifentanil Anesthetics, Intravenous Central Nervous System Depressants |
Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Analgesics, Opioid Analgesics Sensory System Agents Peripheral Nervous System Agents Hypnotics and Sedatives Anesthetics, General |
ClinicalTrials.gov processed this record on May 22, 2013