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Clinical Trials/NCT03931902
NCT03931902
Completed
Not Applicable

The Comparison of Laryngeal Mask Airway and Endotracheal Tube in Premature Neonates Undergoing General Anesthesia for Inguinal Hernia Repair Surgery

Kaohsiung Medical University Chung-Ho Memorial Hospital1 site in 1 country43 target enrollmentSeptember 12, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Preterm Infant
Sponsor
Kaohsiung Medical University Chung-Ho Memorial Hospital
Enrollment
43
Locations
1
Primary Endpoint
Perioperative respiratory complication
Status
Completed
Last Updated
4 years ago

Overview

Brief Summary

Objectives: To compare the perioperative respiratory adverse events between using laryngeal mask airway and endotracheal tube in preterm neonates receiving general anesthesia for hernia surgery.

Detailed Description

The participant patients will be randomly allocated into two groups: the laryngeal mask airway group (LMA group) and endotracheal tube group (ETT group). Masking ventilation with sevoflurane will be used for anesthesia induction till the adequate anesthetic depth. Intubation with laryngeal mask airway (LMA) or endotracheal tube (ETT) will be done as allocated group. After the surgery completed and the patient wakened up, the anesthesiologist will remove the LMA or ETT according to the clinical criteria for extubation.

Registry
clinicaltrials.gov
Start Date
September 12, 2019
End Date
May 25, 2021
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • preterm neonates (gestational age \< 37 weeks) in our neonatal ward scheduled to receive unilateral or bilateral inguinal hernia repair surgery, and whose body weight \> 2000g at surgery

Exclusion Criteria

  • emergent surgery, infants who was intubated before surgery, long-term oxygen or mechanical ventilation dependence, severe congenital cardiopulmonary disease, lacking of birth history, combination with other major surgery, postmenstrual age \> 52 weeks at surgery

Outcomes

Primary Outcomes

Perioperative respiratory complication

Time Frame: from induction of anesthesia to postoperative 24 hours

laryngospasm, bronchospasm, severe cough, delayed extubation or prolonged oxygen dependence, apnea, bradycardia, and postoperative stridor

postoperative hospital stays

Time Frame: from postoperative day 1 up to postoperative day 30

the lengths of postoperative hospital stays

Study Sites (1)

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