We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Try the New Site
We're building a modernized ClinicalTrials.gov! Visit Beta.ClinicalTrials.gov to try the new functionality.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02696837
Recruitment Status : Completed
First Posted : March 2, 2016
Last Update Posted : June 1, 2016
Sponsor:
Collaborators:
Pendik State Hospital
Hisar Intercontinental Hospital
Information provided by (Responsible Party):
Asst. Prof. Serkan Tulgar, M.D., Maltepe University

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Inguinal Hernia Endotracheal Intubation Laryngeal Mask Muscle Relaxants Device: ETT Device: Proseal LMA Drug: Rocuronium Other: No Muscle Relaxant Not Applicable

Detailed 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.

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Official Title: Safety Control Study in Pediatric Inguinal Hernia Repair: Are Muscle Relaxants Necessary? Endotracheal Intubation vs Laryngeal Mask Airway
Study Start Date : March 2016
Actual Primary Completion Date : May 2016
Actual Study Completion Date : May 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hernia

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Active Comparator: ETT & Muscle Relaxant
Children undergoing laparoscopic inguinal hernia repair using PIRS method with Endotracheal Intubation and Muscle Relaxant
 Device: ETT
Drug: Rocuronium
Active Comparator: ETT & No Muscle Relaxant
Children undergoing laparoscopic inguinal hernia repair using PIRS method with Endotracheal Intubation and No Muscle Relaxant
 Device: ETT
Other: No Muscle Relaxant
Active Comparator: Proseal LMA & No Muscle Relaxant
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
Active Comparator: Proseal LMA & Subparalytic Muscle Relaxant
Children undergoing laparoscopic inguinal hernia repair using PIRS method with Proseal Laryngeal Mask Airway and subparalytic dose Muscle Relaxant
 Device: Proseal LMA
Drug: Rocuronium


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  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 ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02696837


Locations
Layout table for location information
Turkey
Maltepe University Hospital
Istanbul, Turkey
Sponsors and Collaborators
Maltepe University
Pendik State Hospital
Hisar Intercontinental Hospital
Investigators
Layout table for investigator information
Principal Investigator: Serkan Tulgar, M.D. Maltepe University
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications of Results:

Other Publications:

Layout table for additonal information
Responsible Party: Asst. Prof. Serkan Tulgar, M.D., Principle Investigator, Maltepe University
ClinicalTrials.gov Identifier: NCT02696837    
Other Study ID Numbers: PIRS002
First Posted: March 2, 2016    Key Record Dates
Last Update Posted: June 1, 2016
Last Verified: May 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
Layout table for MeSH terms
Muscle Hypotonia
Hernia
Hernia, Inguinal
Pathological Conditions, Anatomical
Hernia, Abdominal
Neuromuscular Manifestations
Neurologic Manifestations
 Nervous System Diseases
Rocuronium
Neuromuscular Nondepolarizing Agents
Neuromuscular Blocking Agents
Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs