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

NCT07557680 | Completed Phase 3 DMC

• 1 other identifier: SIUT-ERC-2024/A-488
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hypertension; Anesthesia; Hemodynamic Response

Keywords

Hypertension; Stress response; Dexmedetomidine; Direct Laryngoscopy

Outcome Measures

Primary Outcomes (4)

• Heart Rate via 3 lead ECG monitor

  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

  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

  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

  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 Outcomes (2)

• Bradycardia (heart rate less than 60 beats per minute)

  Perioperative

• Hypotension

  Perioperative

Study Arms (2)

Normal saline

PLACEBO COMPARATOR

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

Dexmedetomidine

EXPERIMENTAL

(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

Interventions

Dexmedetomidine DRUG

Dexmedetomidine (0.5 mcg/kg) diluted in 20 mLs of normal saline was administered intravenously using a syringe pump over 10 min.

Also known as: Normal saline

Dexmedetomidine

Normal Saline OTHER

20 mLs of normal saline was administered intravenously using a syringe pump over 10 min.

Also known as: dexmedetomidine

Normal saline

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sindh Institute of Urology and Transplantation: lead

Study Sites (1)

Sindh Institute of Urology and Transplantation

Karachi, Sindh, 74200, Pakistan

Location

MeSH Terms

Conditions

Hypertension; Fractures, Stress

Interventions

Dexmedetomidine; Saline Solution

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Fractures, Bone; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Syed M Abbas

  Sindh Institute of Urology and Transplantation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The sample was split into a 1:1 control group and a dexmedetomidine group at random. The dexmedetomidine group was infused with 0.5 μg/kg of dexmedetomidine in 20 mL of 0.9% saline. Whereas the control group was infused with 20 mL of 0.9% saline only. The preparation of the study infusions was carried out by an independent anaesthesiologist who was not engaged in the care or data collection of the patients. The participants, as well as the outcome assessors, were blinded regarding grouping. The study infusion was assigned and administered within ten minutes of the anaesthetic 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: The method of non-probability consecutive sampling was utilized to select the eligible participants until the necessary sample size was obtained. The patients who were aged 20-70 years, who had controlled hypertension under the antihypertensive therapy, and who were ASA II were included14. Hypertension was recognized as a measurement of systolic blood pressure surpassing 140 mmHg or diastolic blood pressure over 90 mmHg, which was sufficiently controlled with medication. Exclusion criteria included severe cardiac arrhythmias, a history of myocardial infarction, severe valvular heart disease, uncontrolled diabetes, severe hepatic or renal dysfunction, beta-blocker use, pregnancy, a known allergy to study medications, and an anticipated difficult airway. 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.

Study Record Dates

• First Submitted: January 5, 2026
• First Posted: April 29, 2026
• Study Start: January 1, 2025
• Primary Completion: June 30, 2025
• Study Completion: June 30, 2025
• Last Updated: April 29, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)