A study to compare the effect of dexmedetomidine when given through intravenous route and inhalational route on heart rate and blood pressure.

A randomized controlled non-inferiority trial to compare the hemodynamic response of two doses of nebulized dexmedetomidine with intravenous dexmedetomidine in adult patients undergoing elective surgeries. - NIL

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/10/058757

Enrollment

111

Registered

2023-10-17

Start date

Unknown

Completion date

Unknown

Last updated

2023-11-13

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

Conditions

Health Condition 1: PCS- Health Condition 2: O- Medical and Surgical

Interventions

Intervention1: Administration of intravenous and nebulized dexmedetomidine as premedication and collecting blood samples for estimation of drug levels in blood: In Group A - Nebulized dexmedetomidine

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients between 18-60 years scheduled for elective surgeries. 2. Patients belonging to the American Society of Anesthesiologists grade 1 and 2.

Exclusion criteria

Exclusion criteria: 1. Patients with known allergy to dexmedetomidine 2. Patients with known cardiac or neurological disease 3. Patients on any regular medication or disease states which might cause sedation, changes in blood pressure or heart rate 4. Patients with known lung disorder.

Design outcomes

Primary

Measure	Time frame
To compare the changes in heart rate and BP with administration of nebulized dexmedetomidine at 3 mcg/kg and 1 mcg/kg with IV loading dose of dexmedetomidine at 1 mcg/kg given over 15 mins in adult patients undergoing elective surgeries under GA.Timepoint: Every 2 min interval throughout the drug administration and till 10 mins after intubation, thereafter every 5 mins until the end of anesthesia and every 15 mins in the post op period till 8 hours.	—

Measure

Time frame

To compare the changes in heart rate and BP with administration of nebulized dexmedetomidine at 3 mcg/kg and 1 mcg/kg with IV loading dose of dexmedetomidine at 1 mcg/kg given over 15 mins in adult patients undergoing elective surgeries under GA.Timepoint: Every 2 min interval throughout the drug administration and till 10 mins after intubation, thereafter every 5 mins until the end of anesthesia and every 15 mins in the post op period till 8 hours.

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Secondary

Measure	Time frame
3. To compare the plasma concentrations of nebulized administration of dexmedetomidine at 3 mcg/kg and 1 mcg/kg with IV loading dose of dexmedetomidine at 1 mcg/kg given over 15 minsTimepoint: Outcome will be analyzed initially at baseline and at after collection of the data for the requisite sample size;To compare the sedation score with nebulized administration of dexmedetomidine at 3 mcg/kg and 1 mcg/kg with IV loading dose of dexmedetomidine at 1 mcg/kg given over 15 minsTimepoint: At the end of drug administration;To determine the association of the changes in heart rate and BP with blood levels of dexmedetomidineTimepoint: Outcome will be analyzed initially at baseline and at after collection of the data for the requisite sample size	—

Measure

Time frame

3. To compare the plasma concentrations of nebulized administration of dexmedetomidine at 3 mcg/kg and 1 mcg/kg with IV loading dose of dexmedetomidine at 1 mcg/kg given over 15 minsTimepoint: Outcome will be analyzed initially at baseline and at after collection of the data for the requisite sample size;To compare the sedation score with nebulized administration of dexmedetomidine at 3 mcg/kg and 1 mcg/kg with IV loading dose of dexmedetomidine at 1 mcg/kg given over 15 minsTimepoint: At the end of drug administration;To determine the association of the changes in heart rate and BP with blood levels of dexmedetomidineTimepoint: Outcome will be analyzed initially at baseline and at after collection of the data for the requisite sample size

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Countries

India

Contacts

Public ContactAdarsha Karegouda Patil

Jawaharlal Institute of Postgraduate Medical Education and Research, Puducherry

drmohanvk@gmail.com9841546265

Outcome results

None listed

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