Sindh Institute of Urology and Transplantation
Karachi, Sindh, 74200, Pakistan
NCT Number: NCT07557680
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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Notify Me18 year–65 year
All sexes
Interventional
Phase 3
Karachi, Sindh, 74200, Pakistan
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
20 mLs of normal saline was administered intravenously using a syringe pump over 10 min.
Other names: dexmedetomidine
Time frame: Perioperative
In the operating room, the ASA standard monitoring was attached to the patient.
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).
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).
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).
Time frame: Perioperative
Measured by an ECG monitor
Time frame: Perioperative
Systolic blood pressure less than 90 mmHg measured via a non-invasive blood pressure device
Sindh Institute of Urology and Transplantation
Other
Role of Intravenous Dexmedetomidine in Attenuation of Hemodynamic Response to Laryngoscopy in Controlled Hypertensive Patients: A Prospective Randomised Double-Blind Study
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