Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619000495123
Ethics application status
Approved
Date submitted
17/03/2019
Date registered
26/03/2019
Date last updated
25/05/2023
Date data sharing statement initially provided
26/03/2019
Date results information initially provided
25/05/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Emergence characteristics comparing Endotrachael tube vs Laryngeal Mask airway during nasal surgery with general anaesthesia using intravenous anaesthetic agents like propofol and remifentanyl.
Scientific title
Emergence characteristics comparing ETT to Reinforced LMA using remifentanil and Propanol during intra nasal surgery- Prospective randomized study
Secondary ID [1] 297733 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anaesthesiology 312061 0
Condition category
Condition code
Anaesthesiology 310625 310625 0 0
Anaesthetics

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
After randomisation they will be allocated to either group A or B. In group A RAE tube size 7 will be used in females and 8 in males. In group B RLMA size 3 or 4 (Flexiplus) will be used in females and males based on the patient recommended body weight. Correct insertion of either airway will be confirmed by the ability to manually ventilate the patient’s lungs and adequate cuff inflation by the absence of an audible gas leak when at the APL valve setting of 15-20cmH2o. Throat pack will be inserted to all participants in the group A to reduce the risk of contamination. In group B it is not inserted, because of the minimal space, with possibility of displacing the RLMA. Blood and secretions from the pharynx contaminating the trachea is prevented by regular suction by the surgeon. Though in group B when RLMA is inserted without the use of muscle relaxants, adequate depth of anaesthesia maintained with total intravenous anaesthesia method and ventilation setting will be pressure controlled ventilation to maintain the eTCO2 in normal limits. Failure of RLMA insertion will be backed with ETT intubation. Blood loss will be measured during intraoperatively and in the postoperative period. At the conclusion of surgery, with anaesthesia maintained, surgeon performs fiberoptic endoscopy to inspect the interior of the laryngeal mask above the larynx or the tracheal tube to its tip. Anaesthetist performs oral suction above the RLMA with the cuff inflated before removal, when the patient is awake and responding to command. Once the patient is extubated, the RLMA airway is examined for the grading of the contamination. Grade 1- Clean, Grade2-lightly soiled, Grade 3-fully soiled and Grade 4 blood inside the RMLA. No strategies but any deviation from protocol a note recorded in data sheet.
Intervention code [1] 313971 0
Prevention
Comparator / control treatment
Reinforced LMA
Control group
Active

Outcomes
Primary outcome [1] 319473 0
time taken to opening eyes on command or respond after termination of the anaesthetic agents
Timepoint [1] 319473 0
Immediately after the termination of the anaesthesia
Outcome Assessment is done by the assistant using timer on monitor
Secondary outcome [1] 368315 0
haemodynamic response to emergence from anaesthesia
Outcome measured is Mean arterial BP mesuared by non invasive Blood pressure by manual sphygmomanometer prior, at and after extubation
Timepoint [1] 368315 0
at the extubation time
Haemodynamic outcome is Mean arterial BP which is measured 2 sets by prior, at and after extubation
Secondary outcome [2] 368316 0
adverse effects on return of airway reflexes like cough and laryngospasm, aspiration of blood, post-operative sore throat
Outcomes measured by observations of events
Timepoint [2] 368316 0
at emergence
Secondary outcome [3] 368317 0
grading the contamination of the Reinforced laryngeal mask airway (RLMA )
Outcome measured by observing the RMLA and referring to grading given in the protocol.( grading of LMA is as follows: Grade 1- Clean, Grade2-lightly soiled, Grade 3-fully soiled and Grade 4 blood inside the RMLA.
Timepoint [3] 368317 0
after extubation
Secondary outcome [4] 368318 0
cost difference between the groups.
Resource: Hospital pharmacy and business manager who know the consumable costs
Timepoint [4] 368318 0
end of the study

Eligibility
Key inclusion criteria
Age between 18-80yrs, ASA I–III scheduled for elective rhinoplasty, mini endoscopic surgery, nasal septal or any other intranasal surgery will be included
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients were excluded if they had a known history of obesity, reflux or hiatus hernia, reflux risk with previous surgery on the oesophagus and extensive pathology on CT scan requiring complex surgery expecting major blood loss. Other exclusion may be in situations of RLMA leakage causing fog or splashes of blood on the endoscopy lens, which could make the surgery difficult requiring, change the RLMA to tracheal tube.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Safety
Statistical methods / analysis
Continuous variables by the “t”-test; categorical variables by Fisher's exact test.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
27/03/2019
Actual
4/04/2019
Date of last participant enrolment
Anticipated
15/06/2022
Actual
15/06/2022
Date of last data collection
Anticipated
30/06/2022
Actual
30/06/2022
Sample size
Target
72
Accrual to date
Final
72
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 13424 0
The Queen Elizabeth Hospital - Woodville
Recruitment postcode(s) [1] 26026 0
5011 - Woodville

Funding & Sponsors
Funding source category [1] 302260 0
Hospital
Name [1] 302260 0
Anaethesia The Queen Elizabeth Hospital
Country [1] 302260 0
Australia
Primary sponsor type
Hospital
Name
Anaethesia The Queen Elizabeth Hospital
Address
Anaethesia The Queen Elizabeth Hospital 28 woodville rd
Woodville South 5011 SA
Country
Australia
Secondary sponsor category [1] 302122 0
None
Name [1] 302122 0
Address [1] 302122 0
Country [1] 302122 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302936 0
Central Adelaide Local Health Network Human Research Ethics Committee
Ethics committee address [1] 302936 0
Central Adelaide Local Health Network Human Research Ethics Committee Human Research Ethics Committee
Woodville SA
Ethics committee country [1] 302936 0
Australia
Date submitted for ethics approval [1] 302936 0
15/10/2018
Approval date [1] 302936 0
21/12/2018
Ethics approval number [1] 302936 0
HREC/18/CALHN/680

Summary
Brief summary
Traditionally ETT is used for the nose surgery for maintenance and protection of the airway during anaesthesia and recovery. There are only a few studies comparing reinforced laryngeal mask airway to ETT and these have shown similar efficacy in achieving the above functions. Reinforced laryngeal mask( RLMA) have been shown however to have a lower incidence of hoarseness, coughing during recovery in the post-anaesthesia care unit (PACU) and oxygen desaturation than patients treated with ETT . There is a paucity of literature on the use of RLMA and emergence characteristics. There are no trials examining the emergence characteristics of patients ventilated with ETT vs RLMA using remifentanil and Propofol. .
We wanted to assess the RLMA for the suitability of its use in intranasal surgery (INS) and assess its safety during the surgery and emergence characteristics at the end of surgery.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 91902 0
A/Prof Vasanth Rao Kadam
Address 91902 0
The Queen Elizabeth hospital, Anaesthesia. 28 woodville rd
Woodville South 5011 SA
Country 91902 0
Australia
Phone 91902 0
+61 882226000
Fax 91902 0
+61882227065
Email 91902 0
[email protected]
Contact person for public queries
Name 91903 0
A/Prof Vasanth Rao Kadam
Address 91903 0
The Queen Elizabeth hospital
28 woodville rd
Woodville South 5011 SA
Country 91903 0
Australia
Phone 91903 0
+61 882226000
Fax 91903 0
+61882227065
Email 91903 0
[email protected]
Contact person for scientific queries
Name 91904 0
A/Prof Vasanth Rao Kadam
Address 91904 0
The Queen Elizabeth hospital
28 woodville rd
Woodville South 5011 SA
Country 91904 0
Australia
Phone 91904 0
+61 882226000
Fax 91904 0
+61882227065
Email 91904 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
7367Ethical approval    No data shared methods proposed at this time 377211-(Uploaded-13-03-2020-18-46-23)-Study-related document.pdf



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.