Home » Trials » SLCTR/2013/012
Randomized controlled trial on the safety of using laryngeal mask airway (LMA), compared to endotracheal tube (ETT) for myringoplasty and mastoid surgery taking less than one and half hours in adults
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SLCTR Registration Number
SLCTR/2013/012
Date of Registration
The date of last modification
Mar 03, 2019
Trial Status
Scientific Title of Trial
Randomized controlled trial on the safety of using laryngeal mask airway (LMA), compared to endotracheal tube (ETT) for myringoplasty and mastoid surgery taking less than one and half hours in adults
Public Title of Trial
A study comparing safety of two types of tubes used for anaesthesia in ear surgery
Disease or Health Condition(s) Studied
Anaesthesia in myringoplasty and mastoid surgery
Scientific Acronym
None
Public Acronym
None
Brief title
None
Universal Trial Number
None
Any other number(s) assigned to the trial and issuing authority
EC-12-036 (Ethics Review Committee of the Faculty of Medicine, University of Colombo)
What is the research question being addressed?
Anaesthesia in myringoplasty and mastoid surgery
Type of study
Interventional
Study design
Allocation
Randomized controlled trial
Masking
Masking not used
Control
Active
Assignment
Parallel
Purpose
Treatment
Study Phase
Not Available
Intervention(s) planned
All patients will be premedicated with diazepam 5mg nocte and mane, metoclopramide 10 mg and omeprazole 40 mg on the preceding evening then 40 mg 2–6 hours before surgery. Anaesthesia will be induced with propofol 2.5mg/kg , fentanyl 100mg intravenously. At loss of eyelid reflex, atracurium 0.5mg/kg will be administered intravenously. Patient will be mask ventilated for 3minutes with 30% Oxygen, 70% N2O and isoflorane then either a LMA or ETT will be inserted to secure the airway.
In the LMA group size 3 LMA will be used for females and size 4 will be used for males. 5ml and 10 ml of air will be used to inflate the cuffs of size 3 and 4 LMAs respectively. In the ETT group 7.5mm tubes will be used for female patients and 8mm ETT will be used for male patients. Cuff pressure for ETT will be maintained with 5-7 ml of air ensuring that no air leak is audible.
Anaesthesia will be maintained in a standard manner , and discontinued at the request of the surgeon. The airway device will be removed at the appropriate time.
Inclusion criteria
Exclusion criteria
Primary outcome(s)
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1.
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[
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Secondary outcome(s)
|
1.
None |
[ None ] |
Target number/sample size
52 ( 26 per group)
Countries of recruitment
Sri Lanka
Anticipated start date
2013-04-01
Anticipated end date
2013-08-05
Date of first enrollment
Date of study completion
Recruitment status
Recruiting
Funding source
None
Regulatory approvals
Status
Approved
Date of Approval
2012-06-21
Approval number
EC-12-036
Details of Ethics Review Committee
| Name: | Ethics Review Committee, Faculty of Medicine, University of Colombo |
| Institutional Address: | No. 25, Kynsey Road, Colombo 00800 Sri Lanka |
| Telephone: | +94-11-2695300 (Extension: 240) |
| Email: | ethicscommitteemfc@gmail.com |
Contact person for Scientific Queries/Principal Investigator
Dr. Ajantha Perera
Consultant Anaesthetist
The National Hospital of Sri Lanka Colombo 10
+94712738750
ajantha_perera_2005@gmail.com
Contact Person for Public Queries
Dr. Ajantha Perera
Consultant Anaesthetist
The National Hospital of Sri Lanka Colombo 10
+94712738750
ajantha_perera_2005@gmail.com
Primary study sponsor/organization
National Hospital of Sri Lanka
Colombo 10
+94-112691111
http://www.nationalhospital.lk
Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?
IPD sharing plan description
Study protocol available
Protocol version and date
Not Available
Protocol URL
Not Available
Results summary available
No
Date of posting results
Date of study completion
Final sample size
Date of first publication
Link to results
Brief summary of results
