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A clinical study to find whether dexmedetomidine provides adequate comfort to patients during awake nasal fibreoptic intubation

Safety and Effectiveness of Dexmedetomidine for sedation during awake nasal fibreoptic intubation ? A prospective, randomized, double blind study

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2012/09/002948
Enrollment
36
Registered
2012-09-03
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

Health Condition 1: null- Scheduled for awake nasal fibreoptic intubation in view of assessed difficult airway

Interventions

Intervention1: dexmedetomidine: 1 mcg/kg as bolus administered IV over 10 minutes prior to fibrescopy Control Intervention1: midazolam and fentanyl: 1 mcg/kg fentanyl and 1 mg midazolam were administe

Sponsors

Kasturba Hospital KMC Manipal
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: All patients between 18-85 years undergoing awake nasal fibreoptic intubation

Exclusion criteria

Exclusion criteria: • ASA physical status IV • Raised intracranial pressure • Uncontrolled seizure disorder and/or known psychiatric illness • Current (in the past 14 days) treatment with an α2 agonist or antagonist • Patients in whom dexmedetomidine or benzodiazepine administration is contra-indicated • Patients with acute unstable angina, laboratory confirmed acute myocardial infarction within the past 6 weeks, heart rate • Patients with elevated SGPT (ALT) and/or SGOT (AST) values of > 2 times the upper limit of normal.

Design outcomes

Primary

MeasureTime frame
safety and effectiveness of dexmedetomidine for sedation during awake nasal fiberoptic intubationTimepoint: Endoscopy time, intubation time and intubation score were done during and immediately following awake fibreoptic intubation

Secondary

MeasureTime frame
adverse eventsTimepoint: during intubation and 24 h after surgery

Countries

India

Contacts

Public ContactTajammul Sayeed

KMC, Manipal

anitharshenoy@yahoo.co.in08202922288

Outcome results

None listed

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