Dexmedetomidine in Attenuation of Haemodynamic Response to Laryngoscopy in Controlled Hypertensive Patients

April 25, 2026 updated by: Syed Muhammad Abbas, Sindh Institute of Urology and Transplantation

Role of Intravenous Dexmedetomidine in Attenuation of Hemodynamic Response to Laryngoscopy in Controlled Hypertensive Patients: A Prospective Randomised Double-Blind Study

This randomized control trial, which was carried out at Sindh Institute of Urology and Transplantation (SIUT), used a non-probability consecutive sampling technique for six months from January 1, 2025, to June 30, 2025.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

A prospective, randomized, blinded, placebo-controlled clinical trial was conducted in the Sindh Institute of Urology and Transplantation (SIUT) Department of Anesthesiology. Before their involvement in the study, all individuals provided written informed consent.

In order to account for potential dropouts, 35 participants were recruited in each group (the dexmedetomidine group and the control group), for a total of 70 participants.

The method of non-probability consecutive sampling was utilized to select the eligible participants until the necessary sample size was obtained.

Randomization was done using computer-generated sequences, while allocation concealment was done using opaque, sealed envelopes. The sample was split into a 1:1 control group and a dexmedetomidine group at random.

Dexmedetomidine: 0.5 μg/kg of dexmedetomidine was prepared in 20 mL of 0.9% saline to infuse in the dexmedetomidine group.

Placebo: 20 mL of 0.9% saline was used to infuse in the control group.

The study infusion was assigned and administered within ten minutes of the anesthetic induction, following baseline monitoring and intravenous cannulation. Non-invasive blood pressure, pulse oximetry, three-lead ECG, end-tidal CO₂ (EtCO₂), and capnography were all part of routine monitoring. Anesthesia was induced with lignocaine. After three minutes of mask ventilation, the experienced anesthesiologists carried out direct laryngoscopy and tracheal intubation, and the laryngoscopy time was measured. Anesthesia was supported by isoflurane in a mixture of air and oxygen, and mechanical ventilation was supported to keep EtCO₂ at 35 to 40 mmHg. Bradycardia (less than 50 beats per minute) was corrected using atropine 0.5 mg intravenously, and hypotension was corrected with ephedrine 5 mg intravenously.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
70

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

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, 74200
        • Sindh Institute of Urology and Transplantation

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Ages from 18 to 65 years.
  • Patients with a known case of controlled hypertension.
  • ASA II
  • Elective surgical procedure under general anaesthesia.
  • Mallampati grades 1 and 2.
  • Patients consenting to participate in this study

Exclusion Criteria:

  • Patients with an anticipated difficult intubation.
  • Those requiring more than 15 seconds or more than one attempt or use of a bougie during laryngoscopy.
  • A patient who has not taken an antihypertensive drug early morning on the day of surgery.
  • Patients with a history of allergy to drugs being used.
  • Patients with uncontrolled hypertension (BP > 140/90 mmHg).
  • History of bradycardia (resting heart rate < 60 bpm).
  • Patients on beta blockers if resting heart rate < 60 bpm.
  • History of valvular heart disease, uncontrolled diabetes, liver, or kidney disease.
  • Pregnancy.

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Normal saline
The control group (Group A) was treated with normal saline 0.9%, constituted as a 20 mL solution in a 25 mL syringe. An independent anaesthesiologist who was not involved in administering general anaesthesia or recording the study parameters prepared the study drug. It was then handed over to the primary anaesthesiologist for administration. The study drugs were administered intravenously using a syringe pump over 10 min.
Other: Normal Saline
20 mLs of normal saline was administered intravenously using a syringe pump over 10 min.
Other Names:
  • dexmedetomidine
Experimental: Dexmedetomidine
(Group B) dexmedetomidine 0.5mcg/kg was constituted as a 20 mL solution in a 25 mL syringe. An independent anaesthesiologist who was not involved in administering general anaesthesia or recording the study parameters prepared the study drug. It was then handed over to the primary anaesthesiologist for administration. The study drugs were administered intravenously using a syringe pump over 10 min.
Drug: Dexmedetomidine
Dexmedetomidine (0.5 mcg/kg) diluted in 20 mLs of normal saline was administered intravenously using a syringe pump over 10 min.
Other Names:
  • Normal saline

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Heart Rate via 3 lead ECG monitor
Time Frame: Perioperative
In the operating room, the ASA standard monitoring was attached to the patient.
Perioperative
Systolic Blood Pressure measured via a non invasive blood pressure device
Time Frame: Perioperative
In the operating room holding area, the ASA standard monitoring was attached to the patient, which includes a non-invasive blood pressure monitor (cuff size was used according to the patient's weight and height).
Perioperative
Diastolic Blood Pressure measured via a non invasive blood pressure device
Time Frame: Perioperative
In the operating room, the ASA standard monitoring was attached to the patient, which includes a non-invasive blood pressure monitor (cuff size was used according to the patient's weight and height).
Perioperative
Mean Blood Pressure measured via a non-invasive blood pressure device
Time Frame: Perioperative
In the operating room, the ASA standard monitoring was attached to the patient, which includes a non-invasive blood pressure monitor (cuff size was used according to the patient's weight and height).
Perioperative

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Bradycardia (heart rate less than 60 beats per minute)
Time Frame: Perioperative
Measured by an ECG monitor
Perioperative
Hypotension
Time Frame: Perioperative
Systolic blood pressure less than 90 mmHg measured via a non-invasive blood pressure device
Perioperative

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Sindh Institute of Urology and Transplantation

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Syed M Abbas, Sindh Institute of Urology and Transplantation

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2025

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 5, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 25, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 29, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 29, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 25, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SIUT-ERC-2024/A-488

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Full anonymous raw data, results and statistical analysis

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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