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

NCT02696837 | Completed DMC

• 1 other identifier: PIRS002
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Inguinal Hernia; Endotracheal Intubation; Laryngeal Mask; Muscle Relaxants

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (4)

ETT & Muscle Relaxant

ACTIVE COMPARATOR

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

Device: ETT; Drug: Rocuronium

ETT & No Muscle Relaxant

ACTIVE COMPARATOR

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

Device: ETT; Other: 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

Device: Proseal LMA; Other: 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

Device: Proseal LMA; Drug: Rocuronium

Interventions

ETT DEVICE

ETT & Muscle Relaxant; ETT & No Muscle Relaxant

Proseal LMA DEVICE

Proseal LMA & No Muscle Relaxant; Proseal LMA & Subparalytic Muscle Relaxant

Rocuronium DRUG

ETT & Muscle Relaxant

No Muscle Relaxant OTHER

ETT & No Muscle Relaxant; Proseal LMA & No Muscle Relaxant

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Children aged 0-18 years
• Diagnosed with inguinal hernia or communicating hydrocele
• Due to undergo laparoscopic inguinal hernia repair

You may not qualify if:

• Previous abdominal surgery
• Comorbidities that will effect surgical time, time under anesthesia, intragastric pressure and abdominal pressure

Sponsors & Collaborators

• Maltepe University: lead
• Pendik State Hospital: collaborator
• Hisar Intercontinental Hospital: collaborator

Study Sites (1)

Maltepe University Hospital

Istanbul, Turkey (Türkiye)

Location

Related Publications (5)

• Thomas DT, Gocmen KB, Tulgar S, Boga I. Percutaneous internal ring suturing is a safe and effective method for the minimal invasive treatment of pediatric inguinal hernia: Experience with 250 cases. J Pediatr Surg. 2016 Aug;51(8):1330-5. doi: 10.1016/j.jpedsurg.2015.11.024. Epub 2015 Dec 11.

  PMID: 26777889 BACKGROUND

• Ozdamar D, Guvenc BH, Toker K, Solak M, Ekingen G. Comparison of the effect of LMA and ETT on ventilation and intragastric pressure in pediatric laparoscopic procedures. Minerva Anestesiol. 2010 Aug;76(8):592-9. Epub 2010 Jun 18.

  PMID: 20661199 RESULT

• Aydogmus MT, Turk HS, Oba S, Unsal O, Sinikoglu SN. Can Supreme laryngeal mask airway be an alternative to endotracheal intubation in laparoscopic surgery? Braz J Anesthesiol. 2014 Jan-Feb;64(1):66-70. doi: 10.1016/j.bjane.2012.12.008. Epub 2013 Dec 3.

  PMID: 24565391 RESULT

• Chen BZ, Tan L, Zhang L, Shang YC. Is muscle relaxant necessary in patients undergoing laparoscopic gynecological surgery with a ProSeal LMA? J Clin Anesth. 2013 Feb;25(1):32-5. doi: 10.1016/j.jclinane.2012.06.004. Epub 2012 Nov 2.

  PMID: 23122973 RESULT

• Liu HC, Tao WK, Zeng RF, ShangGuang WN, Li J, Huang WG, Dong ZL, Wang X, Lian QQ. Dose requirements of remifentanil for intubation in nonparalyzed Chinese children. Paediatr Anaesth. 2014 May;24(5):505-9. doi: 10.1111/pan.12354. Epub 2014 Feb 7.

  PMID: 24708453 RESULT

MeSH Terms

Conditions

Hernia, Inguinal; Muscle Hypotonia

Interventions

Rocuronium

Condition Hierarchy (Ancestors)

Hernia, Abdominal; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Androstanols; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Serkan Tulgar, M.D.

  Maltepe University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: February 22, 2016
• First Posted: March 2, 2016
• Study Start: March 1, 2016
• Primary Completion: May 1, 2016
• Study Completion: May 1, 2016
• Last Updated: June 1, 2016

Record last verified: 2016-05

Locations

TU (1)