Anesthetic Management in Fetoscopic Surgery and Incidence of Complications

NCT02434926 | Completed DMC

• 1 other identifier: 150/2558(EC2)
• Study Type: observational
• Target: 152
• Locations: 1 country
• Sites: 2

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.

Conditions

Fetoscopy; Anesthetic Complications; Pregnancy

Keywords

fetoscopy; fetal surgery; anesthetic complications

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Types and quantity of anesthetic medications used

  in operating theatre

• Incidence of complications

  in operating theatre

• Incidence of complications

  after surgery till patients discharge from the hospital

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Pregnant women who received fetocsopic surgery for any reasons eg. laser ablation of vessels in twin-twin transfusion syndrome, balloon occlusion in fetal congenital diaphragmatic hernia, fetal bladder outlet obstruction, intrauterine blood transfusion etc.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Mahidol University: lead

Study Sites (2)

Anesthesiology department, Siriraj hospital, Mahidol University

Bangkok, 10700, Thailand

Location

Siriraj Hospital, Mahidol University

Bangkok, 10700, Thailand

Location

Related 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.

  PMID: 27501618 BACKGROUND

Study Officials

• Patchareya Nivatpumin, M.D.

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 26, 2015
• First Posted: May 6, 2015
• Study Start: May 1, 2015
• Primary Completion: January 1, 2016
• Study Completion: February 1, 2016
• Last Updated: November 15, 2023

Record last verified: 2023-11

Locations

TH (2)