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New Options for Preoperative Anesthesia in Intrauterine Needling

NCT ID: NCT01013558

Last Updated: 2009-12-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-09-30

Study Completion Date

2007-12-31

Brief Summary

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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

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Conditions

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Stress Pain

Keywords

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fetal pain intrauterine needling

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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remifentanil

Group Type ACTIVE_COMPARATOR

Remifentanil

Intervention Type DRUG

0.15 microgram/kg/min continuous infusion.

saline

Group Type PLACEBO_COMPARATOR

saline

Intervention Type DRUG

continuous infusion

Interventions

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Remifentanil

0.15 microgram/kg/min continuous infusion.

Intervention Type DRUG

saline

continuous infusion

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* severe adipositas
* suspicion of structural anomalies
* fetal hydrops
* contraindication for remifentanil
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Leuven University Medical Center

UNKNOWN

Sponsor Role collaborator

Leiden University Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Leiden University Medical Center

Principal Investigators

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Frank P.H.A. Vandenbussche, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Leiden University Medical Center

Locations

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Leiden University Medical Center

Leiden, , Netherlands

Site Status

Countries

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Netherlands

References

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Andrewartha K, Grivell RM. Perioperative pharmacological interventions for fetal immobilisation during fetal surgery and invasive procedures. Cochrane Database Syst Rev. 2022 May 13;5(5):CD011068. doi: 10.1002/14651858.CD011068.pub2.

Reference Type DERIVED
PMID: 35553414 (View on PubMed)

Other Identifiers

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P04.014

Identifier Type: -

Identifier Source: org_study_id