Two different types of airway devices in gall bladder surgeries

Phase 4

Not yet recruiting

Conditions: Other Procedures,

Registration Number: CTRI/2022/06/043473

Lead Sponsor: M D M Hospital Dr S N Medical College Jodhpur

Brief Summary: This study will be carried out in the Department of Anaesthesiology and Critical care, Dr S. N. Medical College, Jodhpur and associated group of hospitals after getting approval from the ethical committee and informed written consent from the study subjects. All patients in this study will be subjected to detailed pre-anaesthetic evaluation which includes: Present complaints, drug history, past history of surgical procedure under regional anaesthesia, history of nausea, retching or vomiting within the preceding 24 hrs, any major medical illness and drug history. Complete general physical examination and ASA grading will be done. All investigations including complete blood profile, random blood sugar, blood urea, serum creatinine, coagulation profile, serum electrolytes, urine analysis, HIV, HBsAg, Chest X-Ray PA view and ECG will be done prior to surgery.

The night before surgery, all patients will be given orally omeprazole 20 mg, ranitidine 150 mg, and alprazolam 0.25 mg and advised to remain nil by mouth as per standard fasting protocol. On arrival of the patient in the operation theatre, the standard ASA non-invasive monitors like electrocardiogram (ECG), non-invasive blood pressure (NIBP) and peripheral oxygen saturation (SpO2) will be applied and the baseline vital parameters (Heart rate, SpO2, Blood pressure (systolic, diastolic, mean arterial pressure) will be recorded. The peripheral intravenous cannula will be secured with 18/20 G on the dorsum of the hand and lactated ringer (RL) solution will be started. The patientsâ€™ randomization will be done by computer-generated random number table and group allocation will be done by sealed opaque envelope method, which will be opened just before induction of anaesthesia**.**

The patient of both groups will bepre-medicated with Midazolam 0.05 mg/kgintravenously (IV) and fentanyl 2Âµg/kg IV. After preoxygenationfor 3 minutes with 100% oxygen, anaesthesia will be induced with propofol 2-3 mg/kg IV till loss of eyelash reflex and no response to jaw thrust and. The airway will be secured 3 minutes after administration of atracurium 0.5 mg/kg IV by one of the airway devices as per study groups after application of 2% lignocaine jelly. The size will be chosen according to body weight. Both devices will be fixed by tapping the tube over the chin.

Anaesthesia will be maintained with an oxygen/air mixture with Sevoflurane (0.6 to 2%) and Inj atracurium 0.1mg/kg using a closed circuit with a circle absorber. The patients will be ventilated with a tidal volume of 6-8 ml/kg at a respiratory rate between 14 and 16 bpm required to maintain normocapnia. During maintenance of anaesthesia, we will record oxygen saturation, HR, BP, end-tidal volume, peak inspiratory pressure, oropharyngeal leak pressure, number of airway manipulations required, and the airway quality by performing neck auscultation and airway complications. At the end of the surgery, anaesthetic agents will be discontinued, and Inj neostigmine 0.05mg/ kg along with Inj glycopyrrolate 0.01mg/kg will be given to reverse the action of muscle relaxation. After the return of adequate spontaneous respiration and muscle power, the device will be removed once the patient is awake.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 70

Inclusion Criteria

American Society of Anaesthesiologists -Physical Status (ASA-PS) class I and II undergoing elective laparoscopic cholecystectomy under general anaesthesia.

Exclusion Criteria

Any patient undergoing emergency surgery, Pregnancy With a prior history of abnormal anatomy of the larynx or pharynx, Suspected difficult airway, Patients with gastric reflex, Increased risk of aspiration.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1.To determine the difference in Oropharyngeal leak pressure between I-gel and Blockbuster LMA at different time interval during laparoscopic cholecystectomy	2 hours

Secondary Outcome Measures

Name	Time	Method
1.To determine the difference in LMA insertion parameters between I-gel and Blockbuster LMA (ease of insertion, insertion time, number of attempts, airway quality)	2.To determine any difference in hemodynamic changes during LMA insertion.

Trial Locations

Locations (1): MDM hospital, Dr. S.N. medical collage, Jodhpur
🇮🇳
Jodhpur, RAJASTHAN, India
MDM hospital, Dr. S.N. medical collage, Jodhpur
🇮🇳Jodhpur, RAJASTHAN, India
DrGeeta Singariya
Principal investigator
9414803554
geetamanojkamal@gmail.com