Efficacy of I gel®, Baska Mask and Blockbuster® LMA for the airway management in laparoscopic gynaecological surgeries: A Randomized controlled trial.
Trial Snapshot
- Phase
- Phase 4
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 99
- Locations
- 1
- Primary Endpoint
- Oropharyngeal leak pressure
Study Overview
Brief Summary
This study is a randomized controlled trial regarding the comparison of oropharyngeal leak pressure between the I-Gel®, Blockbuster®, and Baska Mask supraglottic airway devices in laparoscopic gynaecological surgeries.The laparoscopic gynaecological surgeries often presents unique challenges during general anaesthesia due to trendelenburg position and pneumoperitoneum .Oropharyngeal leak pressure (OLP) is an essential indicator of airway seal and is directly correlated with successful ventilation during laparoscopic gynaecological surgeries . Limited research has been conducted to compare the oropharyngeal leak pressure of different supraglottic airway devices, specifically in laroscopic gynaecological surgeries.
Research hypothesis is we hypothesise that Baska Mask and Blockbuster SAD will have a higher OLP as compared to I gel in patients undergoing laparoscopic gynaecological surgery.
The primary objective is to compare the oropharyngeal leak pressure between I-gel®, Blockbuster®, and Baska Mask during laparoscopic gynaecological surgeries, and the secondary objective is to evaluate and compare: The peak pressure before and after pneumoperitoneum, Insertion attempt, Insertion time, Number and type of airway manipulation required, Perioperative and postoperative anaesthesia related problems.
The inclusion criteria include patients between 18 to 60 years of age, ASA physical status I–II, BMI 18 to 30, and the exclusion criteria include Patient refusal, Anticipated difficult airway, History of gastroesophageal reflux diseases, Patients with previous abdominal surgery and/or comorbidities that would affect surgical time, time under anaesthesia, intragastric pressure and abdominal pressure., Expected duration of surgery > 3 hours, Any surgery with expected postoperative ICU admission.
The sample size was calculated based on the study by Jeon WJ et al. a sample size of 99 patients (33 each group) will be taken, considering dropouts and errors in the sample size calculation.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- Participant Blinded
Eligibility Criteria
- Ages
- 18.00 Year(s) to 60.00 Year(s) (—)
- Sex
- Female
Inclusion Criteria
- •ASA physical status I & II
- •BMI: 18 to 30.
Exclusion Criteria
- •Patient refusal
- •Anticipated difficult airway
- •History of gastroesophageal reflux diseases
- •Patients with previous abdominal surgery or comorbidities that would affect surgical time, time under anaesthesia, intragastric pressure and abdominal pressure.
- •Expected duration of surgery more than 3 hours.
- •Any surgery with expected postoperative ICU admission.
Outcomes
Primary Outcomes
Oropharyngeal leak pressure
Time Frame: T1: After successful insertion of the SAD | T2: 15 minutes after pneumoperitonium and Trendelenburg position | T3: 1 hour after pneumoperitonium and Trendelenburg position
Secondary Outcomes
- Peak pressure(Insertion attempt)
Investigators
Preeti
AIIMS PATNA
