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 yet recruiting

• Conditions: Diseases of middle ear and mastoid,

• Registration Number: CTRI/2020/07/026344
• Lead Sponsor: department of anaesthesia and intensive care

Brief Summary

The main aim of the study is to observe the effect of intratracheal administration of dexmedeomidine on recovery from general anaesthesia in patients undergoing middle ear surgery. reduction in coughing response on extubation is observed as primary outcome. Any change in hemodynamic parameters are also noted. The patients undergoing middle ear surgery are recruited under this study.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2020-02-07
• Study Start: 2020-03-07

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 50

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

Name	Time	Method
1)To compare coughing during recovery from general anaesthesia as a primary outcome	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

Name	Time	Method
2)To compare hemodynamic parameters, sedation and pain as secondary outcomes and complication if any	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).

Trial Locations

Locations (1)

Govt Medical College and hospital sec 32 Chandigarh; 🇮🇳 Chandigarh, CHANDIGARH, India

Govt Medical College and hospital sec 32 Chandigarh

🇮🇳Chandigarh, CHANDIGARH, India

Sakshee Yogendra

Principal investigator

7837979806

saksheeyogendra@gmail.com