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Emergence characteristics comparing Endotrachael tube vs Laryngeal Mask airway during nasal surgery with general anaesthesia using intravenous anaesthetic agents like propofol and remifentanyl.

Emergence characteristics comparing ETT to Reinforced LMA using remifentanil and Propanol during intra nasal surgery- Prospective randomized study

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12619000495123
Enrollment
72
Registered
2019-03-26
Start date
2019-04-04
Completion date
2022-06-15
Last updated
2023-06-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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 inser

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.

Sponsors

Anaethesia The Queen Elizabeth Hospital
Lead SponsorHospital

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used) (Subject)

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years
Healthy volunteers
No

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

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.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026