Remifentanil for General Anesthesia in Preeclamptics

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2007 by Istanbul University.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Istanbul University
ClinicalTrials.gov Identifier:
NCT00567957
First received: December 4, 2007
Last updated: NA
Last verified: December 2007
History: No changes posted
  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

Resource links provided by NLM:


Further study details as provided by Istanbul University:

Primary Outcome Measures:
  • Blood pressure [ Time Frame: Induction to post-intubation period ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
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
Hypertension, Pregnancy-Induced
Pre-Eclampsia
Pregnancy Complications
Cardiovascular Diseases
Vascular Diseases
Anesthetics
Remifentanil
Analgesics
Analgesics, Opioid
Anesthetics, General
Anesthetics, Intravenous
Central Nervous System Agents
Central Nervous System Depressants
Hypnotics and Sedatives
Narcotics
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 20, 2014