Skip to main content
OpenTrials
Completed

NCT Number: NCT02696837

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Inguinal Hernia Endotracheal Intubation Hernia Hernia, Abdominal Hernia, Inguinal Laryngeal Mask Muscle Hypotonia Muscle Relaxants Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

Up to 18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Maltepe University Hospital

Istanbul, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ETT

Device

Proseal LMA

Device

Rocuronium

Drug

No Muscle Relaxant

Other

Primary outcomes

  1. Surgery Time

    Time frame: Intraoperative

    Time from skin prep to last suture

  2. Time Under Anesthesia

    Time frame: Intraoperative

    Time from induction to moderate Alderete score of 9 or above

  3. Intragastric Pressure

    Time frame: Intraoperative continuous monitoring

  4. Intraabdominal Pressure

    Time frame: Intraoperative continuous monitoring

Sponsors and collaborators

Lead sponsor

Maltepe University

Other

Collaborators

  • Hisar Intercontinental Hospital
  • Pendik State Hospital

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Mar 2, 2016
Registry last updated
Jun 1, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.