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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02696837
Enrollment
80
Registered
2016-03-02
Start date
2016-03-31
Completion date
2016-05-31
Last updated
2016-06-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Inguinal Hernia, Endotracheal Intubation, Laryngeal Mask, Muscle Relaxants

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.

Interventions

DEVICEETT
DRUGRocuronium

Sponsors

Pendik State Hospital
CollaboratorUNKNOWN
Hisar Intercontinental Hospital
CollaboratorOTHER
Maltepe University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
No minimum to 18 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Surgery TimeIntraoperativeTime from skin prep to last suture
Time Under AnesthesiaIntraoperativeTime from induction to moderate Alderete score of 9 or above
Intragastric PressureIntraoperative continuous monitoring
Intraabdominal PressureIntraoperative continuous monitoring

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026