Study to assess the usefulness of a new drug, Dexmedetomidine, for sedation of patients during insertion of a tube in the wind pipe using endoscopy before anaesthesia

Phase 3

Completed

Conditions: Health Condition 1: null- Patients requiring awake fibreoptic intubation prior to induction of general anaesthesia

Registration Number: CTRI/2012/08/002858

Lead Sponsor: Tata Memorial Hospital

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 80

Inclusion Criteria

1)Patients undergoing major head and neck surgeries scheduled for an elective nasal awake fibreoptic intubation due to an anticipated difficult airway

2)ASA Physical Status I-II.

Exclusion Criteria

1)Pregnant or lactating females

2)Use of an Î±-2-adrenoreceptor agonist or antagonist within 14 days

3)Use of an opiod administered orally or intravenously within 1 hr or intramuscularly within 4 hrs

4)Presence of increased intracranial pressure or CSF leak

5)Acute alcohol intoxication

6)Uncontrolled seizure disorder

7)History of acute unstable angina

8)Laboratory in acute MI within past 6wks

9)Heart rate 50 beats per minute

10)Systolic blood pressure 90mmhg

11)Complete heart block unless patient had a pacemaker

12)Liver transaminase level 2 times the upper normal limit.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1)Ease of intubation:(acceptable score 3 to 6; not acceptable 6): median score and no. of patients <br/ ><br>2)Percentage of patients requiring Midazolam for rescue sedation to achieve or maintain Ramsay Sedation Scale â?¥2 throughout the study. <br/ ><br>3)Patient tolerance of procedure (no. of patients with a tolerance score of 1 or 2) <br/ ><br>4)Patient cooperation (no. of patients with a score of 1) <br/ ><br>Timepoint: Till completion of fibreoptic intubation and induction of general anaesthesia

Secondary Outcome Measures

Name	Time	Method
1)Mean dose of Midazolam required and number of patients in each group requiring resuce midazolam <br/ ><br>2)Haemodynamic instability <br/ ><br>3)Anaesthesiologistâ??s assessment of ease of patient care (either easy or not easy) <br/ ><br>4)Recall of anxiety, pain and the procedure itself during the AFOI.Timepoint: upto 24 hours after the procedure