Anesthetic Management in Fetoscopic Surgery and Incidence of Complications

NCT ID: NCT02434926

Last Updated: 2023-11-15

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 152 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-05-31
• Study Completion Date: 2016-02-29

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.

Conditions

Fetoscopy; Anesthetic Complications; Pregnancy

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: RETROSPECTIVE

Eligibility Criteria

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.

• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Mahidol University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Patchareya Nivatpumin, M.D.

Role: PRINCIPAL_INVESTIGATOR

Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand

Locations

Anesthesiology department, Siriraj hospital, Mahidol University

Bangkok, , Thailand

Siriraj Hospital, Mahidol University

Bangkok, , Thailand

Countries

Thailand

References

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.

Reference Type: BACKGROUND

PMID: 27501618 (View on PubMed)

Other Identifiers

150/2558(EC2)

Identifier Type: -

Identifier Source: org_study_id