Inguinal HerniaNCT02696837
Pediatric Inguinal Hernia Repair: Are Muscle Relaxants Necessary? Endotracheal Intubation vs Laryngeal Mask Airway
A study testing ETT, Proseal LMA and Rocuronium in people with Inguinal Hernia and Endotracheal Intubation, run by Maltepe University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Inguinal Hernia, Endotracheal Intubation, Laryngeal Mask
- What is being tested?
- ETT, Proseal LMA and Rocuronium
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Mar 2016to May 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Children aged 0-18 years
- Diagnosed with inguinal hernia or communicating hydrocele
- Due to undergo laparoscopic inguinal hernia repair
Who cannot join
- Previous abdominal surgery
- Comorbidities that will effect surgical time, time under anesthesia, intragastric pressure and abdominal pressure
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Safety Control Study in Pediatric Inguinal Hernia Repair: Are Muscle Relaxants Necessary? Endotracheal Intubation vs Laryngeal Mask Airway
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.
Read the 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.
- Being tested
- ETT, Proseal LMA, Rocuronium, No Muscle Relaxant
- Medical subject headings
- Hernia, Inguinal, Muscle Hypotonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ETTDevice
Proseal LMADevice
RocuroniumDrug
No Muscle RelaxantOther
RocuroniumDrug
| Study group | Role | What they receive |
|---|---|---|
| ETT & Muscle Relaxant | Active comparator | Children undergoing laparoscopic inguinal hernia repair using PIRS method with Endotracheal Intubation and Muscle Relaxant Receives: 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 Receives: 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 Receives: 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 Receives: Device: Proseal LMA; Drug: Rocuronium |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surgery Time
Time from skin prep to last suture
Measured: Intraoperative
Time Under Anesthesia
Time from induction to moderate Alderete score of 9 or above
Measured: Intraoperative
Intragastric Pressure
Measured: Intraoperative continuous monitoring
Intraabdominal Pressure
Measured: Intraoperative continuous monitoring
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2016 (estimated)
- Study startMar 2016
- Primary completionMay 2016
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Inguinal HerniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maltepe University
- Sponsor type
- University, hospital or other
- Collaborators
- Pendik State Hospital, Hisar Intercontinental Hospital
- Responsible party
- Principal investigator, Asst. Prof. Serkan Tulgar, M.D., Maltepe University
- Investigators
- Serkan Tulgar, M.D., Principal investigator, Maltepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02696837
- Sponsor's protocol ID
- PIRS002
- Status last verified
- May 2016
- First submitted
- 22 Feb 2016
- Last updated
- 1 Jun 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
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.
PubMed 26777889Ozdamar 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.
PubMed 20661199Aydogmus 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.
PubMed 24565391Chen 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.
PubMed 23122973Liu 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.
PubMed 24708453
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety Control Study in Pediatric Inguinal Hernia Repair: Are Muscle Relaxants Necessary? Endotracheal Intubation vs Laryngeal Mask Airway
- ClinicalTrials.gov ID
- NCT02696837
- Acronym / sponsor ID
- PIRS002
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Maltepe UniversityUniversity, hospital or other
- Collaborators
- Pendik State Hospital, Hisar Intercontinental Hospital
- Study start
- Mar 2016
- Primary completion
- May 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 2 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| ETT & Muscle Relaxant | Active comparator | Device: ETT, Drug: RocuroniumChildren undergoing laparoscopic inguinal hernia repair using PIRS method with Endotracheal Intubation and Muscle Relaxant |
| ETT & No Muscle Relaxant | Active comparator | Device: ETT, Other: No Muscle RelaxantChildren undergoing laparoscopic inguinal hernia repair using PIRS method with Endotracheal Intubation and No Muscle Relaxant |
| Proseal LMA & No Muscle Relaxant | Active comparator | Device: Proseal LMA, Other: No Muscle RelaxantChildren undergoing laparoscopic inguinal hernia repair using PIRS method with Proseal Laryngeal Mask Airway and NO Muscle Relaxant |
| Proseal LMA & Subparalytic Muscle Relaxant | Active comparator | Device: Proseal LMA, Drug: RocuroniumChildren undergoing laparoscopic inguinal hernia repair using PIRS method with Proseal Laryngeal Mask Airway and subparalytic dose Muscle Relaxant |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Children aged 0-18 years
- Diagnosed with inguinal hernia or communicating hydrocele
- Due to undergo laparoscopic inguinal hernia repair
Key exclusion criteria (2 listed)
- Previous abdominal surgery
- Comorbidities that will effect surgical time, time under anesthesia, intragastric pressure and abdominal pressure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 |
| Rocuronium | Drug | Proseal LMA & Subparalytic Muscle Relaxant |
Primary outcome
Surgery Time
Time frame: Intraoperative
Time from skin prep to last suture
Time Under Anesthesia
Time frame: Intraoperative
Time from induction to moderate Alderete score of 9 or above
Intragastric Pressure
Time frame: Intraoperative continuous monitoring
Intraabdominal Pressure
Time frame: Intraoperative continuous monitoring
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2016.
- Background: PubMed 26777889Thomas 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.
- Results publication: PubMed 20661199Ozdamar 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.
- Results publication: PubMed 24565391Aydogmus 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.
- Results publication: PubMed 23122973Chen 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.
- Results publication: PubMed 24708453Liu 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Serkan Tulgar, M.D. principal investigator
Maltepe University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ETT, Proseal LMA and Rocuronium in people with Inguinal Hernia and Endotracheal Intubation, run by Maltepe University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Surgery Time (time frame: Intraoperative). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02696837, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2016.