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A comparative study of three medicines Dexmedetomidine, Fentanyl and Ketamine for comfort and safety during awake fiberoptic intubation.

A randomised controlled double-blinded study comparing intubation conditions, patient comfort, and hemodynamic stability with Dexmedetomidine, Fentanyl, and Ketamine when combined with Midazolam during awake fiberoptic intubation. - Nil

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/11/096818
Enrollment
75
Registered
2025-11-03
Start date
Unknown
Completion date
Unknown
Last updated
2025-11-17

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

Conditions

Health Condition 1: Z018- Encounter for other specified special examinations

Interventions

Intervention1: Dexmedetomidine: Dexmedetomidine 1 µg/kg intravenous infusion over 10 minutes, given 10 minutes before awake fiberoptic intubation, combined with Midazolam 0.02 mg/kg IV bolus. Airway t

Sponsors

PACIFIC MEDICAL COLLEGE AND HOSPITAL UDAIPUR
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients aged 18 to 65 requiring awake fibreoptic intubation. ASA Physical Status I–III. Patients giving informed consent. Patients with an anticipated difficult airway based on clinical predictors (e.g., limited mouth opening, restricted neck movement, high Mallampati grade, facial anomalies, or history of difficult intubation).

Exclusion criteria

Exclusion criteria: Participants refused to sign informed consent. ASA Physical Status IV-V. Severe cardiovascular instability. Pregnant or lactating women. Patients with increased intracranial or intraocular pressure.

Design outcomes

Primary

MeasureTime frame
To determine the most effective sedative combination for improving intubation conditions during awake fiberoptic intubation.Timepoint: To determine the most effective sedative combination for improving intubation conditions during awake fiberoptic intubation at baseline, 5min, 10min, 15min,30min—

Secondary

MeasureTime frame
Hemodynamic StabilityTimepoint: Hemodynamic parameters will be recorded at baseline (pre-drug), after premedication, 5 min and 10 min after infusion start, during topical anaesthesia, bronchoscope insertion, intubation, 15 min and 30 min post-intubation, every 30 min till end of surgery, at post-extubation (0 min), 15 min and 30 min post-extubation.;Patient Comfort / Sedation (Modified OAA/S score)Timepoint: Sedation score (Modified OAA/S) will be assessed at the end of loading dose infusion, before intubation, and after intubation.—

Countries

India

Contacts

Public ContactDr Rajendra Solanki

Pacific Medical College and Hospital

dr.rajendrasolanki51@gmail.com9414131931

Outcome results

None listed

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