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

Comparison of the safety and effectiveness of dexmedetomidine with a combination of midazolam and fentanyl for sedation during awake fibreoptic nasotracheal intubation - A prospective, randomized, double-blind study

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2010/091/003044
Enrollment
30
Registered
2010-12-09
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- Patients who are scheduled to undergo surgery and require awake nasal fibreoptic intubation in view of anticipated difficult oral intubation

Interventions

Intervention1: dexmedetomidine 1&micro
g/kg administered intravenously over 10 minutes prior to attempting awake nasal fibreoptic intubation: Control Intervention1: Fentanyl 1&micro
g/kg administered intravenously and midazolam 1mg intravenous prior to attempting awake nasal fibreoptic intubation:

Sponsors

Anitha Shenoy
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Inclusion criteria : Patients of either gender aged above 18 years requiring awake nasal fibreoptic intubation

Exclusion criteria

Exclusion criteria: Exclusion Criteria: Patients with ASA physical status IV, raised intracranial pressure, uncontrolled seizure disorder / known psychiatric illness, receiving α2 agonists/antagonists in the past two weeks, where either dexmedetomidine or benzodiazepine administration is contra-indicated and patients with acute unstable angina, laboratory confirmed acute myocardial infarction within the past 6 weeks, heart rate <50bpm, systolic blood pressure <90 mmHg, or complete heart block unless they have a pacemaker, patients with elevated liver enzymes > 2 times normal

Design outcomes

Primary

MeasureTime frame
Fibrescopy score Intubation score Post intubation scoreTimepoint: At end of visualisation of glottis At point of intubation At end of intubation

Secondary

MeasureTime frame
Time for endoscopy and time for intubation Ease of endoscopy and intubation Number of attempts taken at endoscopy and intubation Postoperative patient satisfaction score Timepoint: At end of intubation process and 24 h after the surgical procedure

Countries

India

Contacts

Public ContactUmesh Goneppanavar

Kasturba Medical College, Manipal

drumeshg@yahoo.co.in0820 9480575663

Outcome results

None listed

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