Cholecystitis, Choledocholithiasis
Conditions
Brief summary
We hypothesise that the use of the LMA-Supreme provides greater ease of insertion and reduced haemodynamic variability during insertion compared to the tracheal tube, whilst still maintaining a patent airway to facilitate elective laparoscopic cholecystectomy in selected patients.
Detailed description
The Laryngeal Mask Airway Supreme(LMA-S) has been used successfully to maintain a patent airway for laparoscopic surgery. Our study compares the use of LMA-S with that of the tracheal tube (ETT) with respect to the ease of insertion and potential haemodynamic disturbance during insertion.
Interventions
Patients who receive the LMA-S
DEVICEEndotracheal Tube
Patients who receive endotracheal intubation
Sponsors
Changi General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
21 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* American Society of Anesthesiologists (ASA) Physical Status 1 and 2 * Undergoing elective laparoscopic cholecystectomy
Exclusion criteria
* BMI \> 30 * Known gastro-oesophageal reflux disease * predicted or documented difficult airway * contraindications to drugs in the standardized anaesthesia protocol
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to Effective Airway | Baseline | Time to achieve effective airway was defined as time between removing the face-mask, inserting the airway device and obtaining a sustained square-wave capnograph trace with manual ventilation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of attempts taken for successful placement of airway device | Baseline | Number of attempts needed for successful placement of either the LMA-Supreme or the tracheal tube, as assigned |
| Number of attempts taken for successful placement of gastric tube | Baseline | Number of attempts needed for successful placement of gastric tube. Correct gastric tube placement was determined by positive suctioning of gastric contents or detection of injected air with epigastric auscultation. |
| Haemodynamic response to insertion of airway device | Baseline, 1 min, 5 min | Systolic blood pressure and heart rate at 0 min, 1 min, 5 min, starting from the time the face mask was removed from the patient's face. |
| Peak airway pressure during pneumoperitoneum | Assessed intra-operatively, during the period of pneumoperitoneum | Peak airway pressure recorded during pneumoperitoneum, measured during the surgery |
| Incidence of post-operative sore throat | Assessed 1 hr after the surgery, at the Recovery Area | Patients were asked about the presence of sore throat - defined as the presence of constant pain in the throat, independent of swallowing, 1 hr after the end of surgery. No further follow-up. |
Countries
Singapore
Outcome results
None listed