Anesthetic Management in Fetoscopic Surgery and Incidence of Complications

Completed

• Conditions: Anesthetic Complications; Fetoscopy; Pregnancy

• Registration Number: NCT02434926
• Lead Sponsor: Mahidol University

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.

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 Timeline

• Study First Submitted: 2015-04-26
• Study First Submitted QC: 2015-04-30
• Study Start: 2015-05
• Study First Posted: 2015-05-06
• Primary Completion: 2016-01
• Study Completion: 2016-02
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-13
• Last Update Posted: 2023-11-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 152

Inclusion Criteria

• pregnant women who received intrauterine minimally invasive surgery from the past until 30 Nov 2015

Read More

Exclusion Criteria

• pregnant women who received intrauterine minimally invasive surgery which was not anesthetized by anesthesiologist.

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Types and quantity of anesthetic medications used	in operating theatre	Types and quantity of anesthetic medications used for anesthetize patients in different anesthetic techniques.
Incidence of complications	after surgery till patients discharge from the hospital	Complications occurring postoperatively include pulmonary edema, fatal death etc.

Trial Locations

Locations (2)

Siriraj Hospital, Mahidol University; 🇹🇭 Bangkok, Thailand

Anesthesiology department, Siriraj hospital, Mahidol University; 🇹🇭 Bangkok, Thailand