Pediatric Inguinal Hernia Repair: Are Muscle Relaxants Necessary? Endotracheal Intubation vs Laryngeal Mask Airway

Not Applicable

Completed

• Conditions: Inguinal Hernia; Endotracheal Intubation; Laryngeal Mask; Muscle Relaxants
• Interventions: Device: Proseal LMA; Device: ETT; Other: No Muscle Relaxant; Drug: Rocuronium

• Registration Number: NCT02696837
• Lead Sponsor: Maltepe University

Brief Summary

In prospective, safety-control study; children undergoing laparoscopic inguinal hernia repair using PIRS (Percutaneous Internal Ring Suturing) method will be randomly assigned into four groups. Gr 1: Endotracheal intubation and muscle relaxant, Gr 2: Endotracheal Intubation without muscle relaxant, Gr 3: Proseal Laryngeal Mask Airway without muscle relaxant, Gr 4: Proseal Laryngeal Mask Airway with subparalytic does muscle relaxant. Apart from standard monitorization, all patients' intragastric pressures will also be monitored. Patients' age at presentation, gender, time of surgery, time of anesthesia, intragastric pressure, intraabdominal pressure, intraoperative findings and complications will be noted and compared between groups.

Detailed Description

In this prospective, safety-control study; children undergoing laparoscopic inguinal hernia repair using PIRS (Percutaneous Internal Ring Suturing) method will be randomly assigned into four groups.

Gr 1: Endotracheal intubation and muscle relaxant, Gr 2: Endotracheal Intubation without muscle relaxant, Gr 3: Proseal Laryngeal Mask Airway without muscle relaxant, Gr 4: Proseal Laryngeal Mask Airway with subparalytic does muscle relaxant.

Apart from standard monitorization, all patients' intragastric pressures will also be monitored. Patients' age at presentation, gender, time of surgery, time of anesthesia, intragastric pressure, intraabdominal pressure, intraoperative findings and complications will be noted and compared between groups.

Study Timeline

• Study First Submitted: 2016-02-22
• Study First Submitted QC: 2016-02-25
• Study Start: 2016-03
• Study First Posted: 2016-03-02
• Status Verified: 2016-05
• Primary Completion: 2016-05
• Study Completion: 2016-05
• Last Update Submitted: 2016-05-28
• Last Update Posted: 2016-06-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• Children aged 0-18 years
• Diagnosed with inguinal hernia or communicating hydrocele
• Due to undergo laparoscopic inguinal hernia repair

Exclusion Criteria

• Previous abdominal surgery
• Comorbidities that will effect surgical time, time under anesthesia, intragastric pressure and abdominal pressure

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Proseal LMA & Subparalytic Muscle Relaxant	Proseal LMA	Children undergoing laparoscopic inguinal hernia repair using PIRS method with Proseal Laryngeal Mask Airway and subparalytic dose Muscle Relaxant
ETT & Muscle Relaxant	ETT	Children undergoing laparoscopic inguinal hernia repair using PIRS method with Endotracheal Intubation and Muscle Relaxant
ETT & No Muscle Relaxant	No Muscle Relaxant	Children undergoing laparoscopic inguinal hernia repair using PIRS method with Endotracheal Intubation and No Muscle Relaxant
ETT & No Muscle Relaxant	ETT	Children undergoing laparoscopic inguinal hernia repair using PIRS method with Endotracheal Intubation and No Muscle Relaxant
Proseal LMA & No Muscle Relaxant	Proseal LMA	Children undergoing laparoscopic inguinal hernia repair using PIRS method with Proseal Laryngeal Mask Airway and NO Muscle Relaxant
Proseal LMA & No Muscle Relaxant	No Muscle Relaxant	Children undergoing laparoscopic inguinal hernia repair using PIRS method with Proseal Laryngeal Mask Airway and NO Muscle Relaxant
Proseal LMA & Subparalytic Muscle Relaxant	Rocuronium	Children undergoing laparoscopic inguinal hernia repair using PIRS method with Proseal Laryngeal Mask Airway and subparalytic dose Muscle Relaxant
ETT & Muscle Relaxant	Rocuronium	Children undergoing laparoscopic inguinal hernia repair using PIRS method with Endotracheal Intubation and Muscle Relaxant

Primary Outcome Measures

Name	Time	Method
Intraabdominal Pressure	Intraoperative continuous monitoring
Surgery Time	Intraoperative	Time from skin prep to last suture
Time Under Anesthesia	Intraoperative	Time from induction to moderate Alderete score of 9 or above
Intragastric Pressure	Intraoperative continuous monitoring

Trial Locations

Locations (1)

Maltepe University Hospital; 🇹🇷 Istanbul, Turkey