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A study in adult patients undergoing general anaesthesia to compare inhaled ropivacaine and dexmedetomidine in reducing heart rate and blood pressure rise during insertion of the breathing tube

A comparative study between preoperative ropivacaine and dexmedetomidine nebulization for attenuation of haemodynamic response to laryngoscopy and endotracheal intubation - NIL

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2026/02/104181
Enrollment
69
Registered
2026-02-18
Start date
Unknown
Completion date
Unknown
Last updated
2026-03-02

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

Conditions

None listed

Interventions

Intervention1: Nebulized Dexmedetomidine: Dexmedetomidine at a dose of 1 mcg/kg diluted to a total volume of 5 mL with normal saline, administered via inhalation i.e nebulization 15 20 minutes prior t

Sponsors

Simantika Datta
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients aged 18 to 60 years. 2. ASA (American Society of Anesthesiologists) Physical Status I or II. 3. Scheduled for elective surgical procedures under general anaesthesia requiring endotracheal intubation.

Exclusion criteria

Exclusion criteria: ASA Physical Status III and above. 2. Known hypersensitivity or contraindication to ropivacaine or dexmedetomidine. 3. Pregnant or lactating women. 4. Patients with anticipated difficult airway 5. Patients with a history of sore throat or upper respiratory tract infection 6. Patients with respiratory diseases affecting airway reactivity (e.g., asthma, COPD). 7. Emergency surgical cases.

Design outcomes

Primary

MeasureTime frame
Comparison of haemodynamic response to laryngoscopy and endotracheal intubation among the three groups, assessed by changes in Heart Rate (HR), Systolic Blood Pressure (SBP), Diastolic Blood Pressure (DBP), and Mean Arterial Pressure (MAP) from baseline.Timepoint: Haemodynamic parameters will be recorded at: T1 Before nebulization T2 After nebulization T3 Immediately before intubation T4 1 minute after intubation T5 3 minutes after intubation T6 5 minutes after intubation T7 10 minutes after intubation

Secondary

MeasureTime frame
Comparison of haemodynamic response during extubation.Timepoint: T8 At closure of skin incision T9 Immediately after tracheal extubation T10 5 minutes post-extubation;Comparison of cough response score during extubation.Timepoint: At time of extubation;Comparison of sedation score.Timepoint: Immediately after nebulization Immediately after extubation 5 minutes after extubation ;Incidence of adverse effects (hypotension, bradycardia, excessive sedation, dry mouth, dizziness, bronchospasm, arrhythmia, LAST).Timepoint:

Countries

India

Contacts

Public ContactSimantika Datta

ICARE Institute of Medical Sciences and Research and Dr. Bidhan Chandra Roy Hospital, Haldia (IIMSAR & BCRHH)

deepakchandra141@gmail.com85443 32212

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Mar 14, 2026