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A Study Comparing Two Types of Sedation (Ketofol and Midazolam) During Flexible Bronchoscopy in Adults

A Prospective Observational Comparison of Safety and Efficacy Between Ketofol and Midazolam Sedation in Flexible Bronchoscopy - nil

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2025/06/088799
Enrollment
80
Registered
2025-06-13
Start date
Unknown
Completion date
Unknown
Last updated
2026-03-30

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

Conditions

Health Condition 1: J958- Other intraoperative and postprocedural complications and disorders of respiratory system, not elsewhere classified

Interventions

Intervention1: Nil: Nil

Sponsors

Santiniketan Medical College
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Adult patients undergoing diagnostic or therapeutic flexible bronchoscopy. Patients who require conscious sedation for the procedure. Patients who are willing and able to provide written informed consent. American Society of Anesthesiologists physical status I to III

Exclusion criteria

Exclusion criteria: Known allergy or hypersensitivity to ketamine, propofol, or midazolam. Severe respiratory failure requiring ventilator support. Severe cardiovascular instability (e.g., hypotension, arrhythmia). Raised intracranial pressure or known seizure disorder. Chronic use of sedatives, opioids, or alcohol dependence. Pregnant or lactating women. Patients with psychiatric illness impairing consent or cooperation. ASA physical status IV or above.

Design outcomes

Primary

MeasureTime frame
Number of cough events and desaturation event(SpO2 less than 90%) during the bronchoscopy procedureTimepoint: During procedure, 30mins after procedure

Secondary

MeasureTime frame
RAAS SCORE Physician and Patient satisfaction score Hemodynamic parameter variations Procedure duration Recovery time Number of supplemental sedative doses Incidence of adverse eventsTimepoint: During the procedure, 30mins and 1 hour post procedure

Countries

India

Contacts

Public ContactSOUMYADEEP GHOSH

DEPARTMENT OF RESPIRATORY MEDICINE , SANTINIKETAN MEDICAL COLLEGE

SOUMYA.JOTERAM@GMAIL.COM09593754343

Outcome results

None listed

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