COMPARISON OF DEXMEDETOMIDINE AND NORMAL SALINE IN NEBULIZATION TO BLUNT HEMODYNAMIC RESPONSE

NCT07596004 | Active Not Recruiting

• 2 other identifiers: BZEHRASMBBIT
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief Summary

BLUNTING OF HEMODYNAMIC RESPONSE WILL BE OBSERVED IN PATIENTS NEBULISED WITH DEXMEDETOMIDINE AND NORMAL SALINE.

Conditions

HEMODYNAMIC RESPONSETO LYRANGOSCOPY AND ENDOTRACHEAL INTUBATION

Outcome Measures

Primary Outcomes (1)

• change in mean artirial pressure and heart rate after lyrangoscopy and intubation

  hemodynamic stress response measured as change in mean arterial pressure and heart rate from baseline. MAP and HR will be recorded at baseline T0, 1 minute post intubation T1 ans 3 minute post intubation T3. Significant stress response is defined as rise in MAP nad HR more than 10% of baseline at 3 minutes post intubation.

  baseline, 1 minute and 3 minute post intubation

Study Arms (2)

nebulised dexmedetomidine

EXPERIMENTAL

participants will receive nebulised dexmedetomidine 1 microgram/kg diluted in 5ml normal saline via nebulised over 5 minutes, administered 30 minutes before induction of anesthesia. standard monitoring of hemodynamic parameters will be done at baseline, 1 minute and 3 minutes post-intubation

Drug: Dexmeditomidine

nebulised saline

PLACEBO COMPARATOR

participants will receive nebulised 5ml normal saline via nebulised over 5 minutes, administered 30 minutes before induction of anesthesia. standard monitoring of hemodynamic parameters will be done at baseline, 1 minute and 3 minutes post-intubation.

Drug: Normal Saline (0.9% Sodium Chloride)

Interventions

Dexmeditomidine DRUG

dexmeditomidine 1mcg/kg diluted in 5ml 0.9% sodium chloride, administered via nebulizer over 5 minutes, 30 minutes prior to anesthetic induction .

nebulised dexmedetomidine

Normal Saline (0.9% Sodium Chloride) DRUG

normal saline 5 ml administered via nebulizer over 5 minutes, 30 minutes prior to anesthetic induction.

nebulised saline

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age 18-60 years
• Either gender
• ASA Physical Status I and II
• Mallampati airway class I and II
• BMI 18-30 kg/m2
• Patients undergoing elective surgery under general anesthesia

You may not qualify if:

• Patient refusal or lack of consent
• Anticipated difficult airway
• Intubation attempt lasting more than 15 seconds
• Pregnancy
• Uncontrolled hypertension, cardiac, pulmonary, hepatic, or cerebral events
• Known allergy to dexmedetomidine or study drugs

Sponsors & Collaborators

• Shaheed Mohtarma Benazir Bhutto Institue of Trauma: lead

Study Sites (1)

SMBBIT

Karachi, Sindh, 7500, Pakistan

Location

MeSH Terms

Interventions

Saline Solution; Sodium Chloride

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Participants were blinded to treatment allocation. Treatment was placed in sealed opaque envelopes and selected randomly. The outcome assessor who recorded blood pressure and heart rate was blinded to group allocation to minimize observer bias.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: BZEHRA

Model Details: Participants were randomly assigned to one of two parallel groups: Group A received nebulised dexmedetomidine 1 mcg/kg, and Group B received nebulised normal saline 5 ml. Both groups received intervention 30 minutes before induction of anesthesia.

Study Record Dates

• First Submitted: May 13, 2026
• First Posted: May 19, 2026
• Study Start: March 10, 2026
• Primary Completion (Estimated): June 15, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: May 19, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)