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OpenTrials
Completed

NCT Number: NCT07557680

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

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Sindh Institute of Urology and Transplantation

Karachi, Sindh, 74200, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Dexmedetomidine

Drug

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

Normal Saline

Other

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

Other names: dexmedetomidine

Primary outcomes

  1. Heart Rate via 3 lead ECG monitor

    Time frame: Perioperative

    In the operating room, the ASA standard monitoring was attached to the patient.

  2. 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).

  3. 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).

  4. 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).

Secondary outcomes

  1. Bradycardia (heart rate less than 60 beats per minute)

    Time frame: Perioperative

    Measured by an ECG monitor

  2. Hypotension

    Time frame: Perioperative

    Systolic blood pressure less than 90 mmHg measured via a non-invasive blood pressure device

Sponsors and collaborators

Lead sponsor

Sindh Institute of Urology and Transplantation

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Apr 29, 2026
Registry last updated
Apr 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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