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To compare the effectiveness between two drugs- dexmedetomidine and remifentanil- for keeping around fifty patients with a seemingly difficult airway calm and comfortable during the awake placement of a breathing tube with the help of a visualizing scope into their windpipe in the first attempt

A Prospective Comparative Study Between Dexmedetomidine And Remifentanil For Sedation In Awake Fibreoptic Nasotracheal Intubation - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/11/097176
Enrollment
50
Registered
2025-11-11
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: M489- Spondylopathy, unspecified

Interventions

Intervention1: Dexmedetomidine for sedation in awake fibreoptic nasotracheal intubation: Dexmedetomidine loading dose of 0.4mcg/kg at a concentration of 2mcg/cc over 10minutes followed by a continuous

Sponsors

MS Ramaiah Medical College
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. 18-75 year olds 2. ASA I-III 3. Maxillofacial trauma patients 4. Patients with oral carcinoma 5. Trismus

Exclusion criteria

Exclusion criteria: 1. Nasal trauma 2. Pregnant and lactating women 3. Heart Rate less than 50 bpm 4. AV block on ECG 5. History of angina 6. Liver cirrhosis 7. History of long time opioid use or use within last 14days 8. Allergy to drugs

Design outcomes

Primary

MeasureTime frame
first attempt success rate and quality of intubationTimepoint: Time interval between sedation and confirmation of ventilation with end tidal carbon dioxide being displayed on the monitor, in the first attempt, approximately 10minutes after the loading dose is completed

Secondary

MeasureTime frame
time required to achieve RSS of 2Timepoint: interval between start of sedation to when patient is cooperative, oriented & tranquil, approximately 5minutes after the loading dose is completed;Total duration for successful tracheal intubationTimepoint: sum of all attempts taken to successfully intubate the patient endotracheally, approximately 15minutes after the loading dose is completed

Countries

India

Contacts

Public ContactDr Geetha C R

M S Ramaiah Medical College

jageedha@yahoo.com9900482828

Outcome results

None listed

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