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

Phase 4

• Conditions: Patients who are scheduled to undergo surgery and require awake nasal fibreoptic intubation in view of anticipated difficult oral intubation

• Registration Number: CTRI/2010/091/003044
• Lead Sponsor: Anitha Shenoy

Brief Summary

This is a prospective, randomized, double-blinded study comparing the safety and efficacy of dexmedetomidine administered at 1µg/kg over 10 min. This is compared with a control group that receives injection 1mg midazolam and fentanyl 1µg/kg. The study will be done in patients requiring awake nasal fibreoptic intubation in view of difficult airway. The primary outcome measures will be the scores observed during fibreoptic scopy, intubation and post intubation.

Detailed Description

Not available

Recruitment & Eligibility

• Sex: All
• Target Recruitment: 30

Inclusion Criteria

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

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Fibrescopy scoreIntubation scorePost intubation score	At end of visualisation of glottisAt point of intubationAt end of intubation

Secondary Outcome Measures

Name	Time	Method
Time for endoscopy and time for intubationEase of endoscopy and intubationNumber of attempts taken at endoscopy and intubationPostoperative patient satisfaction score	At end of intubation process and 24 h after the surgical procedure

Trial Locations

Locations (1)

Department of Anaesthesia, Kasturba Hospital, Manipal; 🇮🇳 Department, India

Department of Anaesthesia, Kasturba Hospital, Manipal

🇮🇳Department, India

Umesh Goneppanavar

Principal investigator

9480575663

drumeshg@yahoo.co.in