Pharmacogenetics of Remifentanil in Patients With Hypertension Undergoing Cesarean Delivery Under General Anesthesia

This study has been completed.
Sponsor:
Collaborator:
General Teaching Hospital, Prague
Information provided by (Responsible Party):
Jan Blaha, MD, PhD., Charles University, Czech Republic
ClinicalTrials.gov Identifier:
NCT01550640
First received: March 6, 2012
Last updated: August 28, 2014
Last verified: August 2014
  Purpose

Caesarean delivery under general anaesthesia (GA) carries nowadays still 25% risk of insufficient depth of anaesthesia in a time before the fetus delivery. The reason is the lack of opioid administration. Opioids easily cross placental barrier and negatively influence newborn postpartum adaptation by respiratory depression. Introduction to GA is thus accompanied by exaggerated autonomic stress reaction with hypertension and tachycardia. The use of ultra-short acting opioid remifentanil should suppress stress response in mother without increasing the risk for newborn. There are only a few clinical data available. This study will be the first one systematically studying the influence of remifentanil in pregnant women with hypertension on hemodynamic stability and newborns safety. This study will also identify potential pharmacogenetic factors of individual variability in remifentanil response with respect of drug efficacy and safety in mother and newborn.


Condition Intervention
Pregnancy
Cesarean Delivery
General Anesthesia
Drug: Remifentanil
Drug: saline

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Pharmacogenetics of Remifentanil in Patients With Hypertension Undergoing Cesarean Delivery Under General Anesthesia

Resource links provided by NLM:


Further study details as provided by Charles University, Czech Republic:

Primary Outcome Measures:
  • Hemodynamic response to intubation and beginning of Cesarean operation [ Time Frame: 30 min from induction to general anesthesia ] [ Designated as safety issue: Yes ]
    Changes in major hemodynamic parameters (Systolic Blood Pressure, Heart Rate, ST analysis)

  • Newborn adaptation after delivery [ Time Frame: 10 min after delivery ] [ Designated as safety issue: Yes ]
    newborn status (Apgar score + acid-base measurement from umbilical cord, clinical evaluation and scoring)


Secondary Outcome Measures:
  • Depth of anesthesia [ Time Frame: 30 min from induction to general anesthesia ] [ Designated as safety issue: No ]
    BIS (continuous bispectral EEG analysis)


Enrollment: 149
Study Start Date: March 2012
Study Completion Date: April 2014
Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: remifentanil
bolus of remifentanil 1 µg/kg will be given 30 sec before induction to general anesthesia
Drug: Remifentanil
bolus of remifentanil 1 µg/kg will be given 30 sec before induction to general anesthesia
Other Name: Ultiva
Placebo Comparator: standard
bolus of saline (placebo) will be given 30 sec before induction to general anesthesia
Drug: saline
bolus of saline will be given 30 sec before induction to general anesthesia
Other Name: placebo

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Pregnant women,
  • age 18+
  • Cesarean delivery under general anesthesia
  • informed consent

Exclusion Criteria:

  • non-cooperative patient
  • previous allergy to remifentanil or additional substance
  • multiparity
  • age of foetus <35th week
  • estimated foetus weight <2500 g
  • hypoxia or other signs of foetus distress
  • mother's hypotension
  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: NCT01550640

Locations
Czech Republic
General University Hospital in Prague
Prague, Czech Republic, 128 08
General University Hospital in Prague
Prague 2, Czech Republic, 128 08
Sponsors and Collaborators
Charles University, Czech Republic
General Teaching Hospital, Prague
  More Information

No publications provided

Responsible Party: Jan Blaha, MD, PhD., Principal Investigator, Charles University, Czech Republic
ClinicalTrials.gov Identifier: NCT01550640     History of Changes
Other Study ID Numbers: remifentanil
Study First Received: March 6, 2012
Last Updated: August 28, 2014
Health Authority: Czech Republic: Ethics Committee

Keywords provided by Charles University, Czech Republic:
remifentanil
Caesarean operation
general anaesthesia
hypertension
newborn's adaptation
pharmacogenetics

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Anesthetics
Remifentanil
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Analgesics, Opioid
Narcotics
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Hypnotics and Sedatives
Anesthetics, Intravenous
Anesthetics, General

ClinicalTrials.gov processed this record on August 28, 2014