New Options for Preoperative Anesthesia in Intrauterine Needling

NCT01013558 | Completed Phase 1

• 1 other identifier: P04.014
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Stress; Pain

Keywords

fetal pain; intrauterine; needling

Outcome Measures

Primary Outcomes (1)

• evidence of fetal stress response by changes in fetal stress hormones beta-endorphin, noradrenalin and cortisol

  15-60 minutes

Secondary Outcomes (1)

• influence of analgesics (remifentanil) on the fetal stress response

  15-60 minutes

Study Arms (2)

remifentanil

ACTIVE COMPARATOR

Drug: Remifentanil

saline

PLACEBO COMPARATOR

Drug: saline

Interventions

Remifentanil DRUG

0.15 microgram/kg/min continuous infusion.

remifentanil

saline DRUG

continuous infusion

saline

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Leiden University Medical Center: lead
• Leuven University Medical Center: collaborator

Study Sites (1)

Leiden University Medical Center

Leiden, 2300 RC, Netherlands

Location

Related Publications (1)

• 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.

  PMID: 35553414 DERIVED

MeSH Terms

Conditions

Pain

Interventions

Remifentanil; Sodium Chloride

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

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

• Frank P.H.A. Vandenbussche, MD PhD

  Leiden University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 10, 2009
• First Posted: November 13, 2009
• Study Start: September 1, 2004
• Primary Completion: December 1, 2007
• Study Completion: December 1, 2007
• Last Updated: December 8, 2009

Record last verified: 2009-11

Locations

NL (1)