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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.

Effect of intratracheal dexmedetomididne administration on recovery from general anaesthesia in middle ear surgery: a randomised double-blinded study.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2020/07/026344
Enrollment
50
Registered
2020-07-03
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: H65-H75- Diseases of middle ear and mastoid

Interventions

Intervention1: Intratracheal administration of dexmedetomidine: Intratracheal administration of dexmedetomidine on recovery from general anaesthesia in patients undergoing middle ear surgery Control I

Sponsors

department of anaesthesia and intensive care
Lead Sponsor

Eligibility

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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).—

Countries

India

Contacts

Public ContactDr Lakesh K Anand

Govt Medical College and Hospital sec 32 Chandigarh

lkanand11@gmail.com9646121522

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026