Anesthetic Management in Fetoscopic Surgery and Incidence of Complications

Sponsor
Mahidol University (Other)
Overall Status
Completed
CT.gov ID
NCT02434926
Collaborator
(none)
152
2
9.1
76
8.4

Study Details

Study Description

Brief Summary

Fetoscopic surgery has been acknowledged to be a reliable procedure to correct several congenital anomalies e.g. shunt insertion in fetal bladder outlet obstruction, laser ablation of vessels in twin-twin transfusion syndrome (TTTS), balloon occlusion in congenital diaphragmatic hernia etc. The technique involves an introduction of small-caliber instruments into the amniotic cavity under ultrasound guidance. This procedure can be successfully done under either general anesthesia, regional anesthesia or local anesthesia with sedation. Each technique has both advantages and drawbacks.

Several complications related to anesthetic after fetoscopic surgery can occur. For instance, pulmonary edema which is caused by intravenous fluid loading, irrigation fluid absorption or fluid flow through myometrium venous channel. Besides, maternal hypotension intraoperatively can arise from spinal anesthesia.

The aim of the study is to report choice of anesthesia using in fetoscopic surgery in the tertiary care institute (Siriraj hospital) and incidence of complications which may relate to different anesthetic techniques.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    The quantity and types of medications using in different anesthetic technique will be gathered including opioid, benzodiazepine, propofol, detail of drugs making fetal paralysis, amount of local anesthetic drug in spinal anesthesia etc. Tocolytic drug will also be recorded eg. terbutaline, nifedipine or magnesium sulfate. These drugs have been generally known that may cause hypotension or pulmonary edema.

    In intraoperative period, the investigators emphasize in the incidence of hypotension and other possible complications such as pulmonary aspiration, failed intubation, maternal desaturation or maternal bradycardia. Volume of intravenous fluid administered and amount of irrigation fluid will also be recorded.

    Maternal and fetal outcome in recovery room and in postoperative period will be collected.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    152 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Retrospective
    Official Title:
    Anesthetic Management in Fetoscopic Surgery and Incidence of Complications - A Retrospective Review
    Study Start Date :
    May 1, 2015
    Actual Primary Completion Date :
    Jan 1, 2016
    Actual Study Completion Date :
    Feb 1, 2016

    Outcome Measures

    Primary Outcome Measures

    1. Type of anesthetic techniques used in fetoscopic surgery [in operating theatre]

      Type of anesthetic techniques eg. general anesthesia, regional anesthesia, local anesthesia with sedation.

    Secondary Outcome Measures

    1. Types and quantity of anesthetic medications used [in operating theatre]

      Types and quantity of anesthetic medications used for anesthetize patients in different anesthetic techniques.

    2. Incidence of complications [in operating theatre]

      Intraoperative complications eg. failed intubation, aspiration, hypotension from spinal anesthesia, high spinal block, desaturation etc.

    3. Incidence of complications [after surgery till patients discharge from the hospital]

      Complications occurring postoperatively include pulmonary edema, fatal death etc.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • pregnant women who received intrauterine minimally invasive surgery from the past until 30 Nov 2015
    Exclusion Criteria:
    • pregnant women who received intrauterine minimally invasive surgery which was not anesthetized by anesthesiologist.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Anesthesiology department, Siriraj hospital, Mahidol University Bangkok Thailand 10700
    2 Siriraj Hospital, Mahidol University Bangkok Thailand 10700

    Sponsors and Collaborators

    • Mahidol University

    Investigators

    • Principal Investigator: Patchareya Nivatpumin, M.D., Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Mahidol University
    ClinicalTrials.gov Identifier:
    NCT02434926
    Other Study ID Numbers:
    • 150/2558(EC2)
    First Posted:
    May 6, 2015
    Last Update Posted:
    Aug 12, 2016
    Last Verified:
    Aug 1, 2016
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Keywords provided by Mahidol University

    Study Results

    No Results Posted as of Aug 12, 2016