A STUDY TO EVALUATE THE ROLE OF MIDAZOLAM BEFORE INDUCTION ON THE EASE OF FACE MASK VENTILATION IN PATIENTS UNDERGOING ELECTIVE SURGERY UNDER GENERAL ANAESTHESIA

Phase 4

Not yet recruiting

• Conditions: Medical and Surgical,

• Registration Number: CTRI/2021/10/037145
• Lead Sponsor: MAULANA AZAD MEDICAL COLLEGE NEW DELHI

Brief Summary

This Study is being conducted to evaluate the effect of Midazolam administration before induction on the ease of face mask ventilation in patients with normal airway. Primary outcome assessed would be difficulty of face mask ventilation assessed by Warters grading scale after study drug administration. Other outcomes assessed would be Incidence of difficult mask ventilation (Warters scale >2) after study drug administration, Anxiety and sedation levels before and after study drug administration: assessed by Numerical Rating Scale & Modified Observer’s Assessment of Alertness / Sedation Scale, respectively.Dose of propofol required for induction of anaesthesia,

Bispectral index (BIS) values measured during mask ventilation after study drug administration, Correlation between BIS values and Warters scale during mask ventilation after study drug administration and adverse effects like incidence of hypotension or bradycardia during study period.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2021-05-10
• Study Start: 2021-10-15

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 56

Inclusion Criteria

AMERICAN SOCIETY OF ANESTHESIOLOGISTS PHYSICAL GRADE I, II.

Exclusion Criteria

• Patients requiring rapid sequence intubation Patients requiring awake intubation.
• Patients with risk of pulmonary aspiration Patients having allergy to the midazolam Patients having current cervical spine disease or history of cervical spine surgery Patients with BMI ≥ 30kg/m2 Patients with history of sleep apnea Patients with craniofacial anomaly Patients having any contraindications to sedative premedication.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Difficulty of face mask ventilation assessed by Warters grading scale after study drug administration	Difficulty of face mask ventilation assessed by warters grading scale 1 min after giving muscle relaxant vecuronium.

Secondary Outcome Measures

Name	Time	Method
Incidence of difficult mask ventilation (Warters scale ≥2) after study drug administration.	The anxiety and sedation levels before and after study drug administration: assessed by Numerical Rating Scale & Modified Observer’s Assessment of Alertness / Sedation Scale, respectively.
Incidence of difficult mask ventilation after study drug administration.	The anxiety and sedation levels before and after study drug administration: assessed by Numerical Rating Scale & Modified Observer’s Assessment of Alertness / Sedation Scale, respectively.

Trial Locations

Locations (1)

MAULANA AZAD MEDICAL COLLEGE AND LOK NAYAK HOSPITAL; 🇮🇳 Central, DELHI, India

MAULANA AZAD MEDICAL COLLEGE AND LOK NAYAK HOSPITAL

🇮🇳Central, DELHI, India

ROSHITA SINGH

Principal investigator

9643037191

anesthesia.roshita.2020@gmail.com