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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Inguinal Hernia, Endotracheal Intubation, Laryngeal Mask, Muscle Relaxants

Intervention / Treatment
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* Device: ETT
* Device: Proseal LMA
* Drug: Rocuronium
* Other: No Muscle Relaxant
* Drug: Rocuronium


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: ETT & Muscle Relaxant<br>Children undergoing laparoscopic inguinal hernia repair using PIRS method with Endotracheal Intubation and Muscle Relaxant | Device: ETT<br> <br> Drug: Rocuronium<br> <br> |
| Active Comparator: ETT & No Muscle Relaxant<br>Children undergoing laparoscopic inguinal hernia repair using PIRS method with Endotracheal Intubation and No Muscle Relaxant | Device: ETT<br> <br> Other: No Muscle Relaxant<br> <br> |
| Active Comparator: Proseal LMA & No Muscle Relaxant<br>Children undergoing laparoscopic inguinal hernia repair using PIRS method with Proseal Laryngeal Mask Airway and NO Muscle Relaxant | Device: Proseal LMA<br> <br> Other: No Muscle Relaxant<br> <br> |
| Active Comparator: Proseal LMA & Subparalytic Muscle Relaxant<br>Children undergoing laparoscopic inguinal hernia repair using PIRS method with Proseal Laryngeal Mask Airway and subparalytic dose Muscle Relaxant | Device: Proseal LMA<br> <br> Drug: Rocuronium<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Surgery Time | Time from skin prep to last suture | Intraoperative | 
| Time Under Anesthesia | Time from induction to moderate Alderete score of 9 or above | Intraoperative | 
| Intragastric Pressure |  | Intraoperative continuous monitoring | 
| Intraabdominal Pressure |  | Intraoperative continuous monitoring |