Comparison of two supraglottic airway devices in patients undergoing surgery under general anaesthesia.
Phase 4
- Conditions
- Health Condition 1: null- patients undergoing surgery under general anaesthesia
- Registration Number
- CTRI/2020/04/024854
- Lead Sponsor
- Department of AnaesthesiologyVardhman Mahavir Medical College and Safdarjung HospitalNew Delhi
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
a)Age group of 18 to 60 years,
b)Weighing 30- 70 Kg ,
c)American society of Anaesthesiologists (ASA) physical status Iand II
d)Undergoing elective surgery under general anaesthesia
Exclusion Criteria
1)Patients with anticipated difficult airway including:
Thyromental distance less than 6.5 cm,
Upper lip bite test class more than 1,
Mallampatti class III and IV,
Restricted head and neck mobility
Mouth opening less than 3.5 cm
BMI more than 30 kg/m 2
2) Cervical spine pathology
3) Intestinal and oesophageal pathology
4) Operation time greater than 4 hours
5) High risk of aspiration ( gastroesophageal reflux/treated disease)
6) Preoperative sore throat
7) Poor dentition with high risk of damage
8) Pregnancy
9) Patients undergoing laparoscopic surgery
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To compare oropharyngeal leak pressure of Baska mask with that of LMA Proseal in adult <br/ ><br>patients undergoing elective surgery under general anaesthesia with controlled ventilation.Timepoint: 5 minutes and 30 minutes
- Secondary Outcome Measures
Name Time Method 1. Number of attempts taken for successful insertion of device- <br/ ><br>2. Time for achieving effective airway: <br/ ><br>3.number of patients requiring manipulation for achieving effective airway and type of manipulation <br/ ><br>4. Ease of insertion of device <br/ ><br>5. Leak percent <br/ ><br>6. Intraoperative ( aspiration, trauma, desaturation, laryngospasm,brochosapsm, airway obstruction) and postoperative adverse events( sorethroat, dysphagia and hoarseness) <br/ ><br>Timepoint: parameter 1-4 will be recorded immediately after insertion of device ( Time 0) <br/ ><br>leak percent will be done 5 min post device insertion <br/ ><br>adverse events will be recorded as follows <br/ ><br>sore throat (1 and 24 hours) <br/ ><br>