NCT01550640

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
149

participants targeted

Target at P50-P75 for not_applicable pregnancy

Timeline
Completed

Started Mar 2011

Typical duration for not_applicable pregnancy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2011

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

March 6, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 12, 2012

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2014

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2014

Completed
Last Updated

November 18, 2014

Status Verified

November 1, 2014

Enrollment Period

3.1 years

First QC Date

March 6, 2012

Last Update Submit

November 14, 2014

Conditions

PregnancyCesarean DeliveryGeneral Anesthesia

Keywords

remifentanilCaesarean operationgeneral anaesthesiahypertensionnewborn's adaptationpharmacogenetics

Outcome Measures

Primary Outcomes (2)

  • Newborn adaptation after delivery

    newborn status (Apgar score + acid-base measurement from umbilical cord, clinical evaluation and scoring)

    10 min after delivery

  • Influence of individual hereditary variability in MDR1 (multidrug resistance gene 1) and PXR (pregnane X receptor) on remifentanil pharmacodynamics.

    at time of delivery

Secondary Outcomes (2)

  • Depth of anesthesia

    30 min from induction to general anesthesia

  • Hemodynamic response to intubation and beginning of Cesarean operation

    30 min from induction to general anesthesia

Study Arms (2)

remifentanil

EXPERIMENTAL

bolus of remifentanil 1 µg/kg will be given 30 sec before induction to general anesthesia

Drug: Remifentanil

standard

NO INTERVENTION

control standard group

Interventions

RemifentanilDRUG

bolus of remifentanil 1 µg/kg will be given 30 sec before induction to general anesthesia

Also known as: Ultiva
remifentanil

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Pregnant women,
  • age 18-45
  • Cesarean delivery under general anesthesia
  • informed consent

You may not qualify if:

  • 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
  • Discontinuation Criteria:
  • \- difficult foetus delivery (uterine incision-to-delivery interval \>3 min)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

General University Hospital in Prague

Prague, 128 08, Czechia

Location

Related Publications (1)

  • Noskova P, Blaha J, Bakhouche H, Kubatova J, Ulrichova J, Marusicova P, Smisek J, Parizek A, Slanar O, Michalek P. Neonatal effect of remifentanil in general anaesthesia for caesarean section: a randomized trial. BMC Anesthesiol. 2015 Mar 26;15:38. doi: 10.1186/s12871-015-0020-1. eCollection 2015.

    PMID: 25821405DERIVED

MeSH Terms

Conditions

Hypertension

Interventions

Remifentanil

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

PropionatesAcids, AcyclicCarboxylic AcidsOrganic ChemicalsPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Jan Blaha, MD, PhD.

    General University Hospital, Prague

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 6, 2012

First Posted

March 12, 2012

Study Start

March 1, 2011

Primary Completion

April 1, 2014

Study Completion

August 1, 2014

Last Updated

November 18, 2014

Record last verified: 2014-11

Locations

CZ(1)