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

Maltepe University

Status: Completed

Conditions: Laryngeal Mask; Endotracheal Intubation; Muscle Relaxants; Inguinal Hernia

Treatments: Other: No Muscle Relaxant; Drug: Rocuronium; Device: Proseal LMA; Device: ETT

Study type: Interventional

Funder types: Other

Identifiers

NCT02696837

PIRS002

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 patients

Sex: All

Ages: Under 18 years old

Volunteers: No Healthy Volunteers

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

Trial design

80 participants in 4 patient groups

ETT & Muscle Relaxant

Active Comparator group

Description:

Children undergoing laparoscopic inguinal hernia repair using PIRS method with Endotracheal Intubation and Muscle Relaxant

Treatment:

Drug: Rocuronium

Device: ETT

Drug: Rocuronium

ETT & No Muscle Relaxant

Active Comparator group

Description:

Children undergoing laparoscopic inguinal hernia repair using PIRS method with Endotracheal Intubation and No Muscle Relaxant

Treatment:

Device: ETT

Other: No Muscle Relaxant

Proseal LMA & No Muscle Relaxant

Active Comparator group

Description:

Children undergoing laparoscopic inguinal hernia repair using PIRS method with Proseal Laryngeal Mask Airway and NO Muscle Relaxant

Treatment:

Device: Proseal LMA

Other: No Muscle Relaxant

Proseal LMA & Subparalytic Muscle Relaxant

Active Comparator group

Description:

Children undergoing laparoscopic inguinal hernia repair using PIRS method with Proseal Laryngeal Mask Airway and subparalytic dose Muscle Relaxant

Treatment:

Drug: Rocuronium

Device: Proseal LMA

Drug: Rocuronium