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NCT03931902 Clinical Trial

The Comparison of Laryngeal Mask Airway and Endotracheal Tube in General Anesthesia for Premature Neonates

Anesthesia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03931902
Other study ID # KMUHIRB-F(II)-20190017
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 12, 2019
Est. completion date May 25, 2021

Study information
Verified date December 2020
Source Kaohsiung Medical University Chung-Ho Memorial Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 43
Est. completion date May 25, 2021
Est. primary completion date May 25, 2021
Accepts healthy volunteers No
Gender All
Age group N/A to 52 Weeks
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• intubation with Endotracheal tube
After masking ventilation with sevoflurane till the adequate anesthetic depth, intubation will be done with endotracheal tube (ETT).
• intubation with laryngeal mask airway
After masking ventilation with sevoflurane till the adequate anesthetic depth, intubation will be done with laryngeal mask airway (LMA).

Locations
Country Name City State
Taiwan Kaohsiung Medical University Hospital Kaohsiung

Sponsors (1)
Lead Sponsor Collaborator
Kaohsiung Medical University Chung-Ho Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome
Type Measure Description Time frame Safety issue
Primary Perioperative respiratory complication laryngospasm, bronchospasm, severe cough, delayed extubation or prolonged oxygen dependence, apnea, bradycardia, and postoperative stridor from induction of anesthesia to postoperative 24 hours
Primary postoperative hospital stays the lengths of postoperative hospital stays from postoperative day 1 up to postoperative day 30
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