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Observe the effect of drug dexmedetomididne which will be instilled inside trachea, during removal of endotracheal tube after completion of surgery, in middle ear surgeries, a randomised controlled trial.

Not Applicable
Conditions
Health Condition 1: H65-H75- Diseases of middle ear and mastoid
Registration Number
CTRI/2020/07/026344
Lead Sponsor
department of anaesthesia and intensive care
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
ot Yet Recruiting
Sex
Not specified
Target Recruitment
0
Inclusion Criteria

1.Patients of age between 18-60 years.

2.American Society of Anaesthesiologists (ASA) physical status I-II.

3.Patients undergoing elective middle ear surgery requiring endotracheal intubation under GA.

Exclusion Criteria

1.Morbid obesity (BMI > 35 kg.m-2).

2.Patients who require rapid sequence induction/ with airway obstruction/ difficult airway

3.Patients with severe cardiovascular, respiratory, hepatic or renal insufficiency.

4.Patients on long-term use of sedative drugs, such as benzodiazepines, barbiturates and other sedative hypnotics.

5.Patient with known allergy to dexmedetomidine.

6.Pregnant women

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
1)To compare coughing during recovery from general anaesthesia as a primary outcomeTimepoint: coughing score at 5 min before anaesthesia (T0), immediately after the administration of dexmedetomidine (T1), 5 min after the administration of dexmedetomidine (T2), 10 min after the administration of dexmedetomidine (T3), at the end of surgery (T4), at the point of awareness (T5), at the point of extubation (T6), 2 min after extubation (T7), 5 min after extubation (T8), 15 min after extubation (T9) and 30 min after extubation (T10).
Secondary Outcome Measures
NameTimeMethod
2)To compare hemodynamic parameters, sedation and pain as secondary outcomes and complication if anyTimepoint: Hemodynamic parameters such as SBP, DBP, MBP and HR values will be recorded 5 min before anaesthesia (T0), immediately after the administration of dexmedetomidine (T1), 5 min after the administration of dexmedetomidine (T2), 10 min after the administration of dexmedetomidine (T3), at the end of surgery (T4), at the point of awareness (T5), at the point of extubation (T6), 2 min after extubation (T7), 5 min after extubation (T8), 15 min after extubation (T9) and 30 min after extubation (T10).
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