Anesthetic Management in Fetoscopic Surgery and Incidence of Complications

Pregnancy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02434926
• Other study ID #: 150/2558(EC2)
• Status: Completed
• Start date: May 2015
• Est. completion date: February 2016

Study information

• Verified date: November 2023
• Source: Mahidol University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 152
• Est. completion date: February 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Anesthetic Complications
• Fetoscopy
• Pregnancy

Locations

Country	Name	City	State
Thailand	Anesthesiology department, Siriraj hospital, Mahidol University	Bangkok
Thailand	Siriraj Hospital, Mahidol University	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Mahidol University

Country where clinical trial is conducted

Thailand, 

References & Publications (1)

Nivatpumin P, Pangthipampai P, Jirativanont T, Dej-Arkom S, Triyasunant N, Tempeetikul T. Anesthetic Techniques and Incidence of Complications in Fetoscopic Surgery. J Med Assoc Thai. 2016 May;99(5):602-10. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Type of anesthetic techniques used in fetoscopic surgery	Type of anesthetic techniques eg. general anesthesia, regional anesthesia, local anesthesia with sedation.	in operating theatre
Secondary	Types and quantity of anesthetic medications used	Types and quantity of anesthetic medications used for anesthetize patients in different anesthetic techniques.	in operating theatre
Secondary	Incidence of complications	Intraoperative complications eg. failed intubation, aspiration, hypotension from spinal anesthesia, high spinal block, desaturation etc.	in operating theatre
Secondary	Incidence of complications	Complications occurring postoperatively include pulmonary edema, fatal death etc.	after surgery till patients discharge from the hospital