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

Inguinal Hernia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02696837
• Other study ID #: PIRS002
• Status: Completed
• Phase: N/A
• First received: February 22, 2016
• Last updated: May 28, 2016
• Start date: March 2016
• Est. completion date: May 2016

Study information

• Verified date: May 2016
• Source: Maltepe University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: May 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 18 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor)

Related Conditions & MeSH terms

• Endotracheal Intubation
• Hernia
• Hernia, Inguinal
• Inguinal Hernia
• Laryngeal Mask
• Muscle Hypotonia
• Muscle Relaxants

Intervention

Device:
• ETT

• Proseal LMA

Drug:
• Rocuronium

Other:
• No Muscle Relaxant

Drug:
• Rocuronium

Locations

Country	Name	City	State
Turkey	Maltepe University Hospital	Istanbul

Sponsors (3)

Lead Sponsor	Collaborator
Maltepe University	Hisar Intercontinental Hospital, Pendik State Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (5)

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. — View Citation

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. — View Citation

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. — View Citation

Ozdamar D, Güvenç 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. — View Citation

Thomas DT, Göcmen 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. 2015 Dec 11. pii: S0022-3468(15)00824-6. doi: 10.1016/j.jpedsurg.2015.11.024. [Epub ahead of print] — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Surgery Time	Time from skin prep to last suture	Intraoperative	Yes
Primary	Time Under Anesthesia	Time from induction to moderate Alderete score of 9 or above	Intraoperative	Yes
Primary	Intragastric Pressure		Intraoperative continuous monitoring	Yes
Primary	Intraabdominal Pressure		Intraoperative continuous monitoring	Yes