Comparison Between Dexmedetomidine-Propofol Injection And Thiopentone-Propofol Injection During I-gel Insertion In General Anaesthesia

Phase 4

Not yet recruiting

Conditions: Calculus of ureter, (2) ICD-10 Condition: M624||Contracture of muscle, (3) ICD-10 Condition: C503||Malignant neoplasm of lower-innerquadrant of breast, (4) ICD-10 Condition: N812||Incomplete uterovaginal prolapse,

Registration Number: CTRI/2023/01/048751

Lead Sponsor: BANKURA SAMMILANI MEDICAL COLLEGE

Brief Summary: MAINTAINANCE OF THE AIRWAY IS AN INTEGRAL PART OF GENERAL ANAESTHESIA. THERE ARE WIDE VARIETY OF SUPRAGLOTTIC AIRWAY DEVICES USED TO MAINTAIN VENTILATION.AMONG THE SECOND GENERATION SUPRAGLOTTIC DEVICES, I-GEL INSERTION IS EASIER AND CAUSES LESSER MORBIDITY OVER OTHER SUPRAGLOTTIC AIRWAY DEVICES.IN THE PRESENT STUDY INSERTION CONDITION OF I-GEL USING DEXMEDETOMIDINE-PROPOFOL (DEXMED:1MCG/KG OVER 10 MINUTES AND PROPOFOL:1 % 0.25ML/KG) INJECTION AND THIOPENTONE-PROPOFOL (ADMIXTURE OF 1.25% OF THIOPENTONE AND 0.5% OF PROPOFOL @0.25ML/KG) IN RANDOMISED DOUBLE BLIND GROUPS WILL BE DONE.EXPECTED OUTCOME IN THIS STUDY WOULD BE COMPARABLE CHANGES IN HEART RATE,MEAN BLOOD PRESSURE,MEAN APNEA TIME WILL BE COMPARED IN BOTH GROUPS.OVERALL I-GEL INSERTION CONDITIONS LIKE (COUGHING,GAGGING,LARYNGOSPASM,LIMB AND HEAD MOVEMENTS) WILL ALSO BE COMPARED IN BOTH GROUPS.DATA WILL BE COLLECTED WITH ALL NECESSARY PREPARATION AND PRECAUTIONS USING PRE-DESIGNED PROFORMA AND WILL BE ANALYSED APPROPRIATE STATISTICAL METHODS.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 80

Inclusion Criteria

.PATIENTS BELONGING TO ASA GRADE 1 AND ASA GRADE2 .PATIENTS UNDERGOING ELECTIVE SURGERIES.

Exclusion Criteria

.UNWILLING PATIENT .PATIENTS HAVING BMI >30 KG/M2 .ORAL OR NASAL SURGERY .ANTICIPATED OR KNOWN DIFFICULT INTUBATION OR VENTILATION .PATIENTS WITH LIMITED MOUTH OPENING (<2CM) .H/O ALLERGY TO ANY STUDY DRUGS .PATIENTS WITH DIFFICULT COMMUNICATIONS .PATIENTS AT INCREASED RISK OF ASPIRATION OR HAVING A HISTORY OF SYMPTOMATIC GASTROESOPHAGEAL REFLUX OR HIATAL HERNIA.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
TO FIND THE DIFFERENCE IN CHANGES IN HEART RATE,MEAN BLOOD PRESSURE,MEAN APNEA TIME IN BOTH GROUPS	6 MONTHS

Secondary Outcome Measures

Name	Time	Method
TO FIND AND COMPARE THE INCIDENCE OF JAW RELAXATION, INTRA-OP LARYNGOSPASM,COUGHING,GAGGING,LIMB AND HEAD MOVEMENT AND OVERALL I-GEL INSERTION CONDITION IN BOTH GROUPS.	6 MONTHS

Trial Locations

Locations (1): BANKURA SAMMILANI MEDICAL COLLEGE AND HOSPITAL
🇮🇳
Bankura, WEST BENGAL, India
BANKURA SAMMILANI MEDICAL COLLEGE AND HOSPITAL
🇮🇳Bankura, WEST BENGAL, India
DR SANDESH RATHOD
Principal investigator
9892921143
srkumarsandesh@gmail.com