HypertensionPhase 3NCT07557680
Dexmedetomidine in Attenuation of Haemodynamic Response to Laryngoscopy in Controlled Hypertensive Patients
A Phase 3 study testing Dexmedetomidine and Normal Saline in people with Hypertension and Hemodynamic Response, run by Sindh Institute of Urology and Transplantation at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Hypertension, Hemodynamic Response, Anesthesia
- What is being tested?
- Dexmedetomidine and Normal Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Jan 2025to 30 Jun 2025
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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).
Show all 9Show fewer
- Patients on beta blockers if resting heart rate < 60 bpm.
- History of valvular heart disease, uncontrolled diabetes, liver, or kidney disease.
- Pregnancy.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Sindh Institute of Urology and Transplantation
Karachi, Sindh, 74200
About this study
Official title: 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.
Read the 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.
- Conditions
- Hypertension, Hemodynamic Response, Anesthesia
- Being tested
- Dexmedetomidine, Normal Saline
- Keywords
- Hypertension, Stress response, Dexmedetomidine, Direct Laryngoscopy
- Medical subject headings
- Hypertension, Fractures, Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
Also called Normal saline
Dexmedetomidine (0.5 mcg/kg) diluted in 20 mLs of normal saline was administered intravenously using a syringe pump over 10 min.
Normal SalineOther
Also called dexmedetomidine
20 mLs of normal saline was administered intravenously using a syringe pump over 10 min.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Dexmedetomidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Heart Rate via 3 lead ECG monitor
In the operating room, the ASA standard monitoring was attached to the patient.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: Perioperative
Secondary outcomes (2)
Bradycardia (heart rate less than 60 beats per minute)
Measured by an ECG monitor
Measured: Perioperative
Hypotension
Systolic blood pressure less than 90 mmHg measured via a non-invasive blood pressure device
Measured: Perioperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2026
- Study start1 Jan 2025
- Primary completion30 Jun 2025
- Study completion30 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sindh Institute of Urology and Transplantation
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Syed Muhammad Abbas, Sindh Institute of Urology and Transplantation
- Investigators
- Syed M Abbas, Principal investigator, Sindh Institute of Urology and Transplantation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07557680
- Sponsor's protocol ID
- SIUT-ERC-2024/A-488
- Status last verified
- Apr 2026
- First submitted
- 5 Jan 2026
- Last updated
- 29 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Full anonymous raw data, results and statistical analysis
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Intravenous Dexmedetomidine in Attenuation of Hemodynamic Response to Laryngoscopy in Controlled Hypertensive Patients: A Prospective Randomised Double-Blind Study
- ClinicalTrials.gov ID
- NCT07557680
- Acronym / sponsor ID
- SIUT-ERC-2024/A-488
- Conditions
- Hypertension, Hemodynamic Response, Anesthesia
- Keywords
- Hypertension, Stress response, Dexmedetomidine, Direct Laryngoscopy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Sindh Institute of Urology and TransplantationUniversity, hospital or other
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 30 Jun 2025 (actual)
- Study completion
- 30 Jun 2025 (actual)
- First posted
- 29 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Normal saline | Placebo comparator | Other: Normal SalineThe 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. |
| Dexmedetomidine | Experimental | Drug: 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (9 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DexmedetomidineAlso: Normal salineDexmedetomidine (0.5 mcg/kg) diluted in 20 mLs of normal saline was administered intravenously using a syringe pump over 10 min. | Drug | Dexmedetomidine |
| Normal SalineAlso: dexmedetomidine20 mLs of normal saline was administered intravenously using a syringe pump over 10 min. | Other | Normal saline |
Primary outcome
Heart Rate via 3 lead ECG monitor
Time frame: Perioperative
In the operating room, the ASA standard monitoring was attached to the patient.
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).
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).
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).
2 secondary outcomes
Bradycardia (heart rate less than 60 beats per minute)
Time frame: Perioperative
Hypotension
Time frame: Perioperative
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2026.
- Individual participant dataSharing planned: No. Full anonymous raw data, results and statistical analysis
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Syed M Abbas principal investigator
Sindh Institute of Urology and Transplantation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Dexmedetomidine and Normal Saline in people with Hypertension and Hemodynamic Response, run by Sindh Institute of Urology and Transplantation at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Heart Rate via 3 lead ECG monitor (time frame: Perioperative). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2026.