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Remifentanil for General Anesthesia in Preeclamptics

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ClinicalTrials.gov Identifier: NCT00567957
Recruitment Status : Unknown
Verified December 2007 by Istanbul University.
Recruitment status was:  Not yet recruiting
First Posted : December 5, 2007
Last Update Posted : December 5, 2007
Sponsor:
Information provided by:

Study Description
Brief 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.

Condition or disease Intervention/treatment Phase
Pre-Eclampsia Hypertension, Pregnancy-Induced Pregnancy Complications Drug: Remifentanil Drug: Saline Phase 4

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 Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Official Title: Remifentanil for c-Section With General Anesthesia in Severe Preeclamptic Patients
Study Start Date : February 2008
Estimated Study Completion Date : December 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anesthesia
U.S. FDA Resources

Arms and Interventions

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 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


Outcome Measures

Primary Outcome Measures :
  1. Blood pressure [ Time Frame: Induction to post-intubation period ]

Secondary Outcome Measures :
  1. Heart rate [ Time Frame: Induction to delivery ]
  2. Amount of additional drugs and fluids if required [ Time Frame: Induction to delivery ]
  3. Evaluation of the newborn [ Time Frame: Within 10 min following delivery ]

Eligibility Criteria

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00567957


Contacts
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

Locations
Turkey
Istanbul University, Istanbul Faculty of Medicine Anesthesiology Dept. Not yet recruiting
Istanbul, Capa, Turkey, 34390
Sponsors and Collaborators
Istanbul University
Investigators
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
First Posted: December 5, 2007    Key Record Dates
Last Update Posted: December 5, 2007
Last Verified: December 2007

Keywords provided by Istanbul University:
pre-eclampsia
remifentanil
anesthesia, general
analgesics, opioid
anesthetics, intravenous
Cesarean section
newborn
maternal haemodynamic

Additional relevant MeSH terms:
Eclampsia
Pre-Eclampsia
Pregnancy Complications
Hypertension, Pregnancy-Induced
Hypertension
Vascular Diseases
Cardiovascular Diseases
Anesthetics
Remifentanil
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics, Opioid
Narcotics
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Hypnotics and Sedatives
Anesthetics, Intravenous
Anesthetics, General