New Options for Preoperative Anesthesia in Intrauterine Needling

Phase 1

Completed

• Conditions: Pain; Stress
• Interventions: Drug: Remifentanil; Drug: saline

• Registration Number: NCT01013558
• Lead Sponsor: Leiden University Medical Center

Brief Summary

The concept of fetal pain is becoming increasingly relevant due to growing possibilities for invasive intrauterine treatment. There is much debate as to whether the fetus is mature enough to be able to perceive pain at all. Recent studies have suggested that the fetus is at least capable of exhibiting a stress response to intrauterine needling. Intrauterine transfusions are most commonly performed by inserting a needle either in the umbilical cord root at the placental surface, or in the intrahepatic portion of the umbilical vein of the fetus. Recently, intrauterine needling in the intrahepatic vein has been shown to result in alterations in fetal stress hormones, which has been interpreted as a reaction to pain. These changes were not observed in intrauterine needling in the umbilical cord root, or after administration of analgesics to the fetus. The investigators tested the hypothesis that remifentanil provides fetal analgesia, assessed by a reduced fetal stress response. The investigators performed a randomised controlled trial comparing fetal stress response between patients undergoing intrauterine transfusions for alloimmune fetal anemia receiving remifentanil, or placebo.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-09
• Primary Completion: 2007-12
• Study Completion: 2007-12
• Status Verified: 2009-11
• Study First Submitted: 2009-11-10
• Study First Submitted QC: 2009-11-12
• Study First Posted: 2009-11-13
• Last Update Submitted: 2009-12-07
• Last Update Posted: 2009-12-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 50

Inclusion Criteria

• singleton pregnancy
• clinically indicated intrauterine transfusion
• red cell alloimmunisation

Exclusion Criteria

• severe adipositas
• suspicion of structural anomalies
• fetal hydrops
• contraindication for remifentanil

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
remifentanil	Remifentanil	-
saline	saline	-

Primary Outcome Measures

Name	Time	Method
evidence of fetal stress response by changes in fetal stress hormones beta-endorphin, noradrenalin and cortisol	15-60 minutes

Secondary Outcome Measures

Name	Time	Method
influence of analgesics (remifentanil) on the fetal stress response	15-60 minutes

Trial Locations

Locations (1)

Leiden University Medical Center; 🇳🇱 Leiden, Netherlands