Clinical trial NCT02434926: Anesthetic Management in Fetoscopic Surgery and Incidence of Complications
Official title: Anesthetic Management in Fetoscopic Surgery and Incidence of Complications - A Retrospective Review
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Fetoscopy
Anesthetic Complications
Pregnancy
Keywords: fetoscopy
fetal surgery
anesthetic complications
Lead sponsor: Mahidol University
Sponsor class: OTHER
First posted: 2015-05-06
Enrollment: 152
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
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.

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.

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.

Primary outcomes:
measure: Type of anesthetic techniques used in fetoscopic surgery
timeFrame: in operating theatre
Secondary outcomes:
measure: Types and quantity of anesthetic medications used
timeFrame: in operating theatre
measure: Incidence of complications
timeFrame: in operating theatre
measure: Incidence of complications
timeFrame: after surgery till patients discharge from the hospital
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Anesthesiology department, Siriraj hospital, Mahidol University
city: Bangkok
country: Thailand
facility: Siriraj Hospital, Mahidol University
Study officials:
affiliation: Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand
name: Patchareya Nivatpumin, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.