Remifentanil for General Anesthesia in Preeclamptics

NCT00567957 | Unknown Phase 4

• 2 other identifiers: RP01BYP-1833
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Pre-Eclampsia; Hypertension, Pregnancy-Induced; Pregnancy Complications

Keywords

pre-eclampsia; remifentanil; anesthesia, general; analgesics, opioid; anesthetics, intravenous; Cesarean section; newborn; maternal haemodynamic

Outcome Measures

Primary Outcomes (1)

• Blood pressure

  Induction to post-intubation period

Secondary Outcomes (3)

• Heart rate

  Induction to delivery

• Amount of additional drugs and fluids if required

  Induction to delivery

• Evaluation of the newborn

  Within 10 min following delivery

Study Arms (2)

C

PLACEBO COMPARATOR

Saline starting before induction till entry to abdominal cavity

Drug: Saline

R

ACTIVE COMPARATOR

Remifentanil starting before induction till entry to abdominal cavity

Drug: Remifentanil

Interventions

Remifentanil DRUG

1 microg/kg iv bolus before induction followed by 0.5 microg/kg/min infusion

Also known as: Ultiva

R

Saline DRUG

same volume iv bolus before induction followed by same volume infusion

Also known as: % 0.9 NaCl

C

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Severe preeclamptic parturients with single fetus pregnancy with contraindication to regional anesthesia

You may not qualify if:

• 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).

Sponsors & Collaborators

• Istanbul University: lead

Study Sites (1)

Istanbul University, Istanbul Faculty of Medicine Anesthesiology Dept.

Istanbul, Capa, 34390, Turkey (Türkiye)

Location

Related Publications (1)

• Ngan Kee WD, Khaw KS, Ma KC, Wong AS, Lee BB, Ng FF. Maternal and neonatal effects of remifentanil at induction of general anesthesia for cesarean delivery: a randomized, double-blind, controlled trial. Anesthesiology. 2006 Jan;104(1):14-20. doi: 10.1097/00000542-200601000-00004.

  PMID: 16394684 BACKGROUND

MeSH Terms

Conditions

Pre-Eclampsia; Hypertension, Pregnancy-Induced; Pregnancy Complications

Interventions

Remifentanil; Sodium Chloride

Condition Hierarchy (Ancestors)

Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Propionates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Tulay Ozkan Seyhan, Associate Prof

  Istanbul University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tulay Ozkan Seyhan, Associate Prof.

CONTACT

+90 212 631 87 67; tulay2000@e-kolay.net

Mukadder Orhan Sungur, Staff

CONTACT

+90 212 631 87 67; mosungur@istanbul.edu.tr

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 4, 2007
• First Posted: December 5, 2007
• Study Start: February 1, 2008
• Study Completion: December 1, 2009
• Last Updated: December 5, 2007

Record last verified: 2007-12

Locations

TU (1)