Trial | NCT02696837  Report issue

Title

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

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    rocuronium ...

  • Study Participants

    80
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.
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 Started
Mar 31
2016
Primary Completion
May 31
2016
Study Completion
May 31
2016
Last Update
Jun 01
2016
Estimate

Device ETT

Device Proseal LMA

Drug Rocuronium

Other No Muscle Relaxant

Drug Rocuronium

ETT & Muscle Relaxant Active Comparator

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

ETT & No Muscle Relaxant Active Comparator

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

Proseal LMA & No Muscle Relaxant Active Comparator

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

Proseal LMA & Subparalytic Muscle Relaxant Active Comparator

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

Criteria 

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
No Results Posted