Evaluation dexmedetomidine nebulization before surgery to reduce the hemodynamic response to laryngoscopic intubation

A DOUBLE BLIND RANDOMISED STUDY TO DETERMINE THE EFFICACY OF DEXMEDETOMIDINE NEBULIZATION IN ATTENUATING THE STRESS RESPONSE TO LARYNGOSCOPY AND INTUBATION - DEXNEB

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2021/09/036244

Enrollment

Registered

2021-09-06

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: K87- Disorders of gallbladder, biliarytract and pancreas in diseases classified elsewhere Health Condition 2: H748- Other specified disorders of middle ear and mastoid Health Condition 3: N630- Unspecified lump in unspecified breast

Interventions

Intervention1: Dexmedetomidine: dexmedetomidine nebulization at a dose of 1Âµg/kg (mixed with saline to a total volume of 5ml) with a nebulizer face mask and a continuous flow of 100% oxygen at 6L/min

Eligibility

Inclusion criteria

Inclusion criteria: 1)ASA 1 and 2 physical status patients 2)Age 18-60yrs with normal airway 3)patients undergoing surgeries under general anesthesia with routine endotracheal intubation who have given informed valid written consent

Exclusion criteria

Exclusion criteria: 1)patients posted for emergency surgeries 2)patients with anticipated or actual difficult airway 3)patients with pregnancy, renal failure, uncontrolled hypertension, seizure disorders, on anti-depressants or anti-psychotics 4)patients with poor cardiopulmonary reserve and with BMI >30kg/m2 5)patients who have not given consent for the study

Design outcomes

Primary

Measure	Time frame
To evaluate the role of nebulized dexmedetomidine as a pre-medication in attenuating the stress response to laryngoscopic intubationTimepoint: baseline heart rate(HR), systolic(SBP), diastolic(DBP) and mean arterial pressure (MAP) noted, HR, SBP, DBP, MAP noted after nebulization, post-intubation 1min, 5min and 10min interval	—

Secondary

Measure	Time frame
To evaluate if dexmedetomidine has any adverse effects such as cough, bradycardia, hypotensionTimepoint: after nebulization, patient is monitored for 10min before induction and half hour after induction for any adverse effects;To evaluate if dexmedetomidine nebulization causes significant sedationTimepoint: 10min after dexmedetomidine nebulization patients level of sedation is assessed using Ramsay sedation scale;To evaluate if dexmedetomidine nebulization reduces the induction dose of propofolTimepoint: 10min after nebulization with dexmedetomidine,the dose of propofol given for induction is noted	—

Measure

Time frame

To evaluate if dexmedetomidine has any adverse effects such as cough, bradycardia, hypotensionTimepoint: after nebulization, patient is monitored for 10min before induction and half hour after induction for any adverse effects;To evaluate if dexmedetomidine nebulization causes significant sedationTimepoint: 10min after dexmedetomidine nebulization patients level of sedation is assessed using Ramsay sedation scale;To evaluate if dexmedetomidine nebulization reduces the induction dose of propofolTimepoint: 10min after nebulization with dexmedetomidine,the dose of propofol given for induction is noted

—

Countries

India

Contacts

Public ContactDr Basavaraj Kallapur

Karnataka Institute of Medical Sciences

doc_basu@yahoo.co.in9449834389

Outcome results

None listed

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