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

M

Maltepe University

Status

Completed

Conditions

Laryngeal Mask
Endotracheal Intubation
Muscle Relaxants
Inguinal Hernia

Treatments

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

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:
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:
Other: No Muscle Relaxant
Device: ETT
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:
Other: No Muscle Relaxant
Device: Proseal LMA
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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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