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: Patients requiring awake fibreoptic intubation prior to induction of general anaesthesia

• Registration Number: CTRI/2012/08/002858
• Lead Sponsor: Tata Memorial Hospital

Brief Summary

Fibreoptic nasotracheal intubation is an effective technique for the management of patients with difficult airways. Obtaining optimal intubating conditions when providing patient comfort and safety are the major goals while preparing the patient for fibreoptic intubation. One challenge associated with this procedure is to provide adequate sedation while maintaining a patent airway and ensuring ventilation. An ideal sedation regimen would provide patient comfort, blunting of airway reflexes, patient cooperation, haemodynamic stability, amnesia and the maintenance of a patent airway with spontaneous ventilation. Conventional sedatives like the benzodiazepines, propofol, or opiates have respiratory-depressant properties that may be detrimental in tenuous airway situations.

Dexmedetomidine is a drug whose clinical profile makes it especially well suited for sedation during awake fibreoptic intubation. It is a highly specific α2-agonist that can produce sedation, anxiolysis, analgesia, and profound levels of sedation in the absence of respiratory depression. The latter property is of special interest in difficult airway cases because during dexmedetomidine administration a stable respiratory pattern is usually seen, with little or no deterioration in respiratory pattern or change in oxygenation.

This study is specifically conducted to determine whether a loading dose of i.v. **dexmedetomidine** beforeawake fibre-optic intubation for patients with difficult airway undergoing General Anaesthesia will provide greater ease of intubation and better patient tolerability,  adequate sedation without respiratory depression and upper airway obstruction and reduced haemodynamic responses as compared to placebo. Rescue sedation will be given in both groups in case of anxiety, agitation or discomfort.

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Detailed Description

Not available

Study Timeline

• Study Start: 2012-06-08
• Last Update Posted: 2016-01-28

Recruitment & Eligibility

• Status: Completed
• Sex: All
• 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 α-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	Till completion of fibreoptic intubation and induction of general anaesthesia
2)Percentage of patients requiring Midazolam for rescue sedation to achieve or maintain Ramsay Sedation Scale ≥2 throughout the study.	Till completion of fibreoptic intubation and induction of general anaesthesia
3)Patient tolerance of procedure (no. of patients with a tolerance score of 1 or 2)	Till completion of fibreoptic intubation and induction of general anaesthesia
4)Patient cooperation (no. of patients with a score of 1)	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	2)Haemodynamic instability

Trial Locations

Locations (1)

Department of Anaesthesia, Tata Memorial Hospital; 🇮🇳 Mumbai, MAHARASHTRA, India

Department of Anaesthesia, Tata Memorial Hospital

🇮🇳Mumbai, MAHARASHTRA, India

JV Divatia

Principal investigator

9869077435

jdivatia@yahoo.com