To see effect of LMA proseal and LMA protector on heart rate and blood pressure after removing endotracheal tube and putting LMA in adult patient coming out of general anaesthesia after surgery

Phase 4

Completed

Conditions: Medical and Surgical,

Registration Number: CTRI/2023/02/049716

Lead Sponsor: Department of Anaesthesia and Intensive Care

Brief Summary: Maintenance of a patent airway is an essential responsibility of anaesthesiologists. Extubation is equally significant as tracheal intubation in a general anaesthesia patient.Awake extubation is mostly considered as safest in anaesthetic practice but is associated with agitation which occurs as a consequence of movement of ETT against the vocal cords,this stimulus can result in tachycardia, coughing and hypertension which can be hazardous for patients especially of ENT surgery, patients with ischemic heart disease, aortic surgery.

The Baileyâ€Ÿs maneuver is a technique for extubating patients in deeper plane of anaesthesia by substituting an oral endotracheal tube for a supraglottic airway device (SAD).This avoids coughing and bucking that is often undesired after certain surgical procedures.SAD has an added benefit of allowing flexible bronchoscope to assess for vocal cord mobility and laryngeal oedema

LMA Protector and LMA Proseal are SAD that can be used for performing Bailey,s Maneuver

Therefore, present study is planned to compare the clinical performance of LMA Protectorâ„¢ and Proseal LMAâ„¢ for Baileyâ€Ÿs maneuver during extubation.

It was decided to enroll a total of 100 subjects for the present trial for patient drop out and additional comparisons. Therefore, after the approval of protocol by the Hospital Ethics Committee, Clinical Trial Registry: India (CTRI) and obtaining informed consent from every patient, a total number of 100 patients admitted for elective surgery under general anaesthesia will be enrolled for the present study as per inclusion and exclusion criteria.

Patients will be evaluated preoperatively on the day prior to surgery,Written informed consent will be taken from all the patients enrolled for the study.Preoperative airway evaluation will be performed and routine investigation would be done for all patient.At the end of surgery,15 min prior to end of surgery, HR, BP, MAP, SPO2, ECG values will be recorded. At the end of surgery, when patient will be still under deep anaesthesia oropharyngeal suction will be done. At this moment SAD will be inserted behind the ETT and its cuff will be inflated.Fibreoptic bronchoscope will be inserted via the airway tube of LMA Protector or Proseal LMA to grade the adequate placement of the device. The grading will be noted. Then HR, BP, MAP, ECG and SPO2 values will be recorded; after SAD is inserted; after removal of ETT and continued at 1,2,3,5 and 10 minutes afterwardsAfter completion of surgery,SAD will be removed HR, BP, MAP, ECG and SPO2 will be recorded immediately after removal of SAD and 1,2,3,5 and 10 minutes afterwards. â€¢ The cough reflex and awakening after extubation will be observed â€¢ Any adverse effects such as bleeding, trauma or sore throat, if any, will be noted in postoperative room till first 24 hours post operatively (Once in post operative room and once after 24 hours of removal of SAD).

All the patient will be transferred to post operative care unit (PACU) for observation before shifting them to respective post operative wards.

All the observations will be noted in prescribed proforma

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 100

Inclusion Criteria

Age group of 18 to 60 years 2.
ASA (American Society of Anaesthesiologists) status I and II 3.
Patients undergoing elective surgery requiring general anaesthesia with endotracheal intubation.

Exclusion Criteria

Patients with difficult airway with Airway difficulty score>8 2.
Morbid obesity BMI > 35 kg/m2 3.
Known airway pathology 4.
Oropharyngeal surgeries 5.
Surgery more than 3 hours 6.
Patients at increased risk of aspiration like gastroesophageal reflux, peptic ulcer 7.
Previous upper gastrointestinal surgery 8.
Known or anticipated difficult tracheal intubation or facemask ventilation 9.
Coagulopathy or history of anticoagulant use 10.
Cardio respiratory or cerebrovascular disease 11.
Cervical spine injury 12.
Pregnant Patients.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To compare the hemodynamic responses during extubation using Baileyâ€Ÿs maneuver with Laryngeal Mask Airway Protector or Proseal LMA	Hemodynamic response would be noted After SAD insertion,after remoal of ETT,1,2,3,5and 10 min afterward and then at SAD removal and 1,2,3,5 and 10 min afterward

Secondary Outcome Measures

Name	Time	Method
1) To compare secondary parameters such as cough reflex awakening after extubation using Baileyâ€Ÿs maneuver with Laryngeal Mask Airway Protector device or Proseal LMA.	2) To observe any adverse effects such as bleeding, trauma or sore throat, if any.

Trial Locations

Locations (1): Government Medical College and Hospital,Sector 32, Chandigarh
🇮🇳
Chandigarh, CHANDIGARH, India
Government Medical College and Hospital,Sector 32, Chandigarh
🇮🇳Chandigarh, CHANDIGARH, India
Kritika Dwivedi
Principal investigator
7351322191
dwivedikritika2.kd@gmail.com