Pediatric Inguinal Hernia Repair: Are Muscle Relaxants Necessary? Endotracheal Intubation vs Laryngeal Mask Airway
NCT ID: NCT02696837
Last Updated: 2016-06-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
80 participants
INTERVENTIONAL
2016-03-31
2016-05-31
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
SINGLE
Study Groups
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ETT & Muscle Relaxant
Children undergoing laparoscopic inguinal hernia repair using PIRS method with Endotracheal Intubation and Muscle Relaxant
ETT
Rocuronium
ETT & No Muscle Relaxant
Children undergoing laparoscopic inguinal hernia repair using PIRS method with Endotracheal Intubation and No Muscle Relaxant
ETT
No Muscle Relaxant
Proseal LMA & No Muscle Relaxant
Children undergoing laparoscopic inguinal hernia repair using PIRS method with Proseal Laryngeal Mask Airway and NO Muscle Relaxant
Proseal LMA
No Muscle Relaxant
Proseal LMA & Subparalytic Muscle Relaxant
Children undergoing laparoscopic inguinal hernia repair using PIRS method with Proseal Laryngeal Mask Airway and subparalytic dose Muscle Relaxant
Proseal LMA
Rocuronium
Interventions
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ETT
Proseal LMA
Rocuronium
No Muscle Relaxant
Rocuronium
Eligibility Criteria
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Inclusion Criteria
* Diagnosed with inguinal hernia or communicating hydrocele
* Due to undergo laparoscopic inguinal hernia repair
Exclusion Criteria
* Comorbidities that will effect surgical time, time under anesthesia, intragastric pressure and abdominal pressure
18 Years
ALL
No
Sponsors
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Pendik State Hospital
UNKNOWN
Hisar Intercontinental Hospital
OTHER
Maltepe University
OTHER
Responsible Party
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Asst. Prof. Serkan Tulgar, M.D.
Principle Investigator
Principal Investigators
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Serkan Tulgar, M.D.
Role: PRINCIPAL_INVESTIGATOR
Maltepe University
Locations
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Maltepe University Hospital
Istanbul, , Turkey (Türkiye)
Countries
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References
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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.
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.
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.
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.
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.
Other Identifiers
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PIRS002
Identifier Type: -
Identifier Source: org_study_id
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