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NCT Number: NCT02434926

Anesthetic Management in Fetoscopic Surgery and Incidence of Complications

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.

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Key information

Conditions

Fetoscopy Anesthetic Complications Pregnancy

Sex eligibility

Female

Study type

Observational

Primary location

Anesthesiology department, Siriraj hospital, Mahidol University, Bangkok, Thailand

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Type of anesthetic techniques used in fetoscopic surgery

    Time frame: in operating theatre

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

Secondary outcomes

  1. Types and quantity of anesthetic medications used

    Time frame: in operating theatre

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

  2. Incidence of complications

    Time frame: in operating theatre

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

  3. Incidence of complications

    Time frame: after surgery till patients discharge from the hospital

    Complications occurring postoperatively include pulmonary edema, fatal death etc.

Sponsors and collaborators

Lead sponsor

Mahidol University

Other

Registry information

Official study title

Anesthetic Management in Fetoscopic Surgery and Incidence of Complications - A Retrospective Review

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
May 6, 2015
Registry last updated
Nov 15, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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