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A clinical trial to study the effects of two drugs, propofol and thiopentone on airway changes in patients during general anaesthesia

Assessment and comparison of airway mechanics during bag mask ventilation using propofol and thiopentone as induction agents. - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/11/060320
Enrollment
90
Registered
2023-11-29
Start date
Unknown
Completion date
Unknown
Last updated
2025-02-03

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

Conditions

Health Condition 1: K802- Calculus of gallbladder without cholecystitis Health Condition 2: O- Medical and Surgical

Interventions

Intervention1: Propofol: Intravenous Propofol (10 mg/ml) of dose titrated to achieve a BIS value of 40-50 will be given at the time of induction of Anesthesia. Control Intervention1: Thiopentone: Intr

Sponsors

Pt BD Sharma PGIMS, Rohtak
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: ASA grade I & II. Posted for elective surgery under general anaesthesia.

Exclusion criteria

Exclusion criteria: Anticipated difficult bag mask ventilation (history of snoring, obesity, large tongue, tonsillar hypertrophy, edentulous and presence of beard etc) and difficult airway (mouth opening less than 3 cm, MPG grade 3 and 4, TMD less than 6.5 cm, restricted neck movements and inability to extend the lower incisor beyond upper incisor) Pregnant patient BMI more than 30 kg/m2 Respiratory disease, increased risk of aspiration Requiring awake intubation History of allergy to study drugs Refusal to participate in the study

Design outcomes

Primary

MeasureTime frame
Comparison of static and dynamic compliance during bag mask ventilation after induction with thiopentone and propofol.Timepoint: 30 sec after achieving clinical end point of induction with thiopentone / propofol and till 30 sec after that (TI, TI1, TI2, TI3, TI4, TI5, TI6 i.e. 30s, 35s, 40s, 45s, 50s, 55s & 60s after induction respectively)

Secondary

MeasureTime frame
To compare and assess 1. Peak inspiratory pressure (PIP) and plateau pressure (PP) at induction & after muscle relaxant (MR) 2. Ratio of expiratory and inspiratory tidal volume (VTe / VTi) after induction & MR 3. Compliance during bag mask ventilation after MR 4. Ease of mask ventilation (Han’s grading scale) 5. Any other adverse effects (bronchospasm, increase airway pressure, hypertension, hypotension, bradycardia, tachycardia, desaturation)Timepoint: 150 sec after giving relaxant and till 30s after that (TM, TM1, TM2, TM3, TM4, TM5, TM6 i.e. 150s, 155s, 160s, 165s, 170s, 175s, 180s after muscle relaxant respectively)

Countries

India

Contacts

Public ContactDr Anurag Das

Pt B D Sharma PGIMS, Rohtak

anuragdas019@gmail.com7044071655

Outcome results

None listed

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