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

May 13, 2026 updated by: BATOOL ZEHRA, Shaheed Mohtarma Benazir Bhutto Institue of Trauma

Comparison of Nebulised Dexmedetomidine Versus Nebulised Saline Preoperatively To Attenuate Hemodynamic Response to Laryngoscopy and Endotracheal Intubation: A Randomised Control Trial

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

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

ONE GROUP OF PTS WILL BE NEBULISED WITH DEXMEDETOMIDINE AND OTHER WITH NORMAL SALINE AND WILL BE OBSERVED DURING AND AFTER INTUBATION FOR ATTENUATION OF HEMODYNAMIC RESPONSE FOR LYRANGOSCOPY AND ENDOTRACHEAL INTUBATION

Study Type

Interventional

Enrollment (Estimated)

66

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Sindh
      • Karachi, Sindh, Pakistan, 7500
        • SMBBIT

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Age 18-60 years
  2. Either gender
  3. ASA Physical Status I and II
  4. Mallampati airway class I and II
  5. BMI 18-30 kg/m2
  6. Patients undergoing elective surgery under general anesthesia

Exclusion Criteria:

  1. Patient refusal or lack of consent
  2. Anticipated difficult airway
  3. Intubation attempt lasting more than 15 seconds
  4. Pregnancy
  5. Uncontrolled hypertension, cardiac, pulmonary, hepatic, or cerebral events
  6. Known allergy to dexmedetomidine or study drugs

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: nebulised dexmedetomidine
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
dexmeditomidine 1mcg/kg diluted in 5ml 0.9% sodium chloride, administered via nebulizer over 5 minutes, 30 minutes prior to anesthetic induction .
Placebo Comparator: nebulised saline
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)
normal saline 5 ml administered via nebulizer over 5 minutes, 30 minutes prior to anesthetic induction.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
change in mean artirial pressure and heart rate after lyrangoscopy and intubation
Time Frame: baseline, 1 minute and 3 minute post 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shaheed Mohtarma Benazir Bhutto Institue of Trauma

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 10, 2026

Primary Completion (Estimated)

June 15, 2026

Study Completion (Estimated)

June 30, 2026

Study Registration Dates

First Submitted

May 13, 2026

First Submitted That Met QC Criteria

May 13, 2026

First Posted (Actual)

May 19, 2026

Study Record Updates

Last Update Posted (Actual)

May 19, 2026

Last Update Submitted That Met QC Criteria

May 13, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BZEHRA
  • SMBBIT (Other Identifier: SMBBIT)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data will not be shared publicly to protect participant confidentiality and privacy as per institutional ethics committee guidelines and informed consent obtained from participants. Data may be shared upon reasonable request to the principal investigator, subject to approval by the institutional ethics committee and execution of a data sharing agreement.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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