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Conscious Sedation for Bronchoscopy: A Randomized Comparison of Midazolam and Ketamine

Conscious Sedation for Bronchoscopy: A Randomized Comparison of Midazolam and Ketamine

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
PACTR
Registry ID
PACTR202602762489607
Enrollment
60
Registered
2026-02-19
Start date
2023-09-01
Completion date
Unknown
Last updated
2026-09-14

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

Conditions

Anaesthesia

Interventions

Midazolam
Ketamine

Sponsors

Faculty of medicine of Tunis University El Manar
Collaborator

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: In this study, we enrolled: - All patients aged over 18 years and under 80 years who had an indication for bronchoscopy (whether admitted to the hospital or as outpatients), for diagnostic or therapeutic purposes - Patients who provided written consent for the procedure.

Exclusion criteria

Exclusion criteria: The presence of at least one of the following criteria was sufficient to render the patient ineligible for this study: -Age under 18 years -Contraindications to sedation: -History of hypersensitivity to midazolam or ketamine (history of paradoxical reaction or anaphylaxis) -Severe hepatic insufficiency (liver failure) -Severe coronary artery disease or severe heart failure -Obstructive sleep apnea-hypopnea syndrome -Severe chronic respiratory failure -Poorly controlled or complicated hypertension

Design outcomes

Primary

MeasureTime frame
The primary outcome criterion was the procedure success rate, with success defined as adequate analgesia using a Numerical Rating Scale (NRS) pain score (scale from 0 to 10 cm) of less than 4/10 and a light to moderate sedation level with a MOAA/S scale score between 3 and 4.

Secondary

MeasureTime frame
The secondary outcome criteria were: -The clinical tolerance of patients to conscious sedation (hemodynamic and respiratory tolerance: primarily the number of desaturation events, defined as SpO2 < 90%). -The comfort and satisfaction felt by the physician were measured using a Likert evaluation scale, scored from 1 (highest discomfort) to 5 (maximum perceived comfort). -The occurrence of adverse events related to the administered medications and the potential use of reversal agents.

Countries

Tunisia

Contacts

Public ContactBoudour Ben Dhia

Dr

boudourbendhia@gmail.com0021654435599

Outcome results

None listed

Source: PACTR (via WHO ICTRP) · Data processed: Sep 19, 2026