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Anesthetic Management in Fetoscopic Surgery and Incidence of Complications

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ClinicalTrials.gov Identifier: NCT02434926
Recruitment Status : Completed
First Posted : May 6, 2015
Last Update Posted : August 12, 2016
Sponsor:
Information provided by (Responsible Party):
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.


Condition or disease
Fetoscopy Anesthetic Complications Pregnancy

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.


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Study Type : Observational
Actual Enrollment : 152 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Anesthetic Management in Fetoscopic Surgery and Incidence of Complications - A Retrospective Review
Study Start Date : May 2015
Actual Primary Completion Date : January 2016
Actual Study Completion Date : February 2016



Primary Outcome Measures :
  1. Type of anesthetic techniques used in fetoscopic surgery [ Time Frame: in operating theatre ]
    Type of anesthetic techniques eg. general anesthesia, regional anesthesia, local anesthesia with sedation.


Secondary Outcome Measures :
  1. Types and quantity of anesthetic medications used [ Time Frame: in operating theatre ]
    Types and quantity of anesthetic medications used for anesthetize patients in different anesthetic techniques.

  2. Incidence of complications [ Time Frame: in operating theatre ]
    Intraoperative complications eg. failed intubation, aspiration, hypotension from spinal anesthesia, high spinal block, desaturation etc.

  3. Incidence of complications [ Time Frame: after surgery till patients discharge from the hospital ]
    Complications occurring postoperatively include pulmonary edema, fatal death etc.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02434926


Locations
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Thailand
Anesthesiology department, Siriraj hospital, Mahidol University
Bangkok, Thailand, 10700
Siriraj Hospital, Mahidol University
Bangkok, Thailand, 10700
Sponsors and Collaborators
Mahidol University
Investigators
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Principal Investigator: Patchareya Nivatpumin, M.D. Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Mahidol University
ClinicalTrials.gov Identifier: NCT02434926     History of Changes
Other Study ID Numbers: 150/2558(EC2)
First Posted: May 6, 2015    Key Record Dates
Last Update Posted: August 12, 2016
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Mahidol University:
fetoscopy
fetal surgery
anesthetic complications
Additional relevant MeSH terms:
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Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs