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

TO EVALUATE THE ROLE OF MIDAZOLAM PREMEDICATION IN FACILITATING FACE MASK VENTILATION DURING INDUCTION OF GENERAL ANAESTHESIA

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2021/10/037145

Enrollment

Registered

2021-10-06

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: - Health Condition 2: O- Medical and Surgical

Interventions

Intervention1: INJECTION MIDAZOLAM 0.035mg/kg intravenous: INJECTION MIDAZOLAM 0.035mg/kg in 3ml of NORMAL SALINE Control Intervention1: NORMAL SALINE 0.9%: 3ml NORMAL SALINE INTRAVENOUS

Eligibility

Inclusion criteria

Inclusion criteria: AMERICAN SOCIETY OF ANESTHESIOLOGISTS PHYSICAL GRADE I, II

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Difficulty of face mask ventilation assessed by Warters grading scale after study drug administrationTimepoint: Difficulty of face mask ventilation assessed by warters grading scale 1 min after giving muscle relaxant vecuronium.	—

Secondary

Measure	Time frame
Incidence of difficult mask ventilation (Warters scale â?¥2) after study drug administration. The anxiety and sedation levels before and after study drug administration: assessed by Numerical Rating Scale & Modified Observerâ??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. Adverse effects: incidence of hypotension or bradycardia during study period.Timepoint: 3 MINUTES;Incidence of difficult mask ventilation (Warters scale â?¥2) after study drug administration. The anxiety and sedation levels before and after study drug administration: assessed by Numerical Rating Scale & Modified Observerâ??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. Adverse effects: incidence of hypotension or bradycardia during study period.Timepoint: 3 MINUTES;Incidence of difficult mask ventilation (Warters scale â?¥2) after study drug administration. The anxiety and sedation levels before and after study drug administration: assessed by Numerical Rating Scale & Modified Observerâ??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. Adverse effects: incidence of hypotension or bradycardia during study period.Timepoint: 3 MINUTES;Incidence of difficult mask ventilation (Warters s	—

Measure

Time frame

Incidence of difficult mask ventilation (Warters scale â?¥2) after study drug administration. The anxiety and sedation levels before and after study drug administration: assessed by Numerical Rating Scale & Modified Observerâ??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. Adverse effects: incidence of hypotension or bradycardia during study period.Timepoint: 3 MINUTES;Incidence of difficult mask ventilation (Warters scale â?¥2) after study drug administration. The anxiety and sedation levels before and after study drug administration: assessed by Numerical Rating Scale & Modified Observerâ??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. Adverse effects: incidence of hypotension or bradycardia during study period.Timepoint: 3 MINUTES;Incidence of difficult mask ventilation (Warters scale â?¥2) after study drug administration. The anxiety and sedation levels before and after study drug administration: assessed by Numerical Rating Scale & Modified Observerâ??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. Adverse effects: incidence of hypotension or bradycardia during study period.Timepoint: 3 MINUTES;Incidence of difficult mask ventilation (Warters s

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Countries

India

Contacts

Public ContactROSHITA SINGH

MAULANA AZAD MEDICAL COLLEGE

Kapsdr@yahoo.com9871262699

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026