CataractPhase 3NCT07080229
Intranasal Dexmedetomidine on Blood Pressure in Elderly Hypertensive Patients Undergoing Cataract Surgery
A Phase 3 study testing Intranasal dexmedetomidine and Intranasal normal saline in people with Cataract and Hypertension, run by Suez Canal University at 1 site in Egypt.
Trial summary
Cataract surgery in elderly patients with controlled hypertension carries a risk of hemodynamic instability, particularly fluctuations in mean arterial blood pressure (MAP). Dexmedetomidine, a selective α2-adrenergic agonist, offers hemodynamic stabilization and sedation when administered intranasally and provides a… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Cataract, Hypertension
- What is being tested?
- Intranasal dexmedetomidine and Intranasal normal saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 126 participants
- Where
- 1 siteEgypt
- Study dates
- 16 Jul 2025to May 2026
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Patients aged ≥65 years.
- Patients who will have stage 2 hypertension as per ACC/AHA guidelines (Systolic BP > 140 and Diastolic BP> 90 mmHg)
- Elective cataract surgery under local anesthesia.
- American Society of Anesthesiologists (ASA) physical status II or III.
Who cannot join
- Allergy or contraindication to dexmedetomidine.
- Significant baseline bradycardia (<50 bpm) or arrhythmias.
- Use of sedative or anxiolytic medications.
- History of severe hepatic, renal, or cerebrovascular diseases.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Suez Canal University Hospitals
Ismailia, Ismailia Governorate, 41522
Mahammad E Salama, MD, 01016865861, mohammadelhossieny88@med.suez.edu.eg
About this study
Official title: The Effect of Intranasal Dexmedetomidine Compared to Placebo on Blood Pressure in Elderly Hypertensive Patients Undergoing Cataract Surgery: A Double-Blind Randomized Controlled Trial
Cataract surgery in elderly patients with controlled hypertension carries a risk of hemodynamic instability, particularly fluctuations in mean arterial blood pressure (MAP). Dexmedetomidine, a selective α2-adrenergic agonist, offers hemodynamic stabilization and sedation when administered intranasally and provides a simple and non-invasive premedication option.
This study evaluates the effects of intranasal dexmedetomidine on perioperative mean arterial blood pressure in patients undergoing cataract surgeries.
Read more
Research Question:
Does intranasal dexmedetomidine premedication control blood pressure in elderly hypertensive patients undergoing cataract surgery?
Research Hypothesis:
Intranasal dexmedetomidine significantly reduces MAP and improves secondary outcomes compared to placebo.
Primary Objective: To evaluate the efficacy of intranasal Dexmedetomidine as a premedication to control hypertension in elderly patients scheduled for cataract surgery.
Secondary Objectives: 1. To assess surgery cancellation rates. 2. To evaluate satisfaction levels among patients, anesthesiologists, and surgeons using the Modified Observer's assessment of alertness/sedation scale (MOAA/S). 3- To evaluate the effect of intranasal dexmedetomidine on HR multiple readings starting from preoperative hold area till 2 hours postoperatively.
This randomized, double-blinded clinical trial will include 126 elderly hypertensive patients (≥65 years) undergoing cataract surgery under local anesthesia. Inclusion Criteria will consist of patients aged ≥65 years, ASA II or III, stage 2 hypertension as per ACC / AHA guidelines (SBP>140 and DBP> 90 mmHg), undergoing elective cataract surgery under local anesthesia. Exclusion Criteria will include allergy or contraindication to dexmedetomidine, significant baseline bradycardia (<50 bpm) or arrhythmia, use of sedative or anxiolytic medications, history of severe hepatic, renal, or cerebrovascular disease. Participants will be randomly assigned to receive either intranasal dexmedetomidine (1 mcg/kg ideal body weight) or a placebo (normal saline) 30 minutes before surgery. MAP, HR, and SpO₂ will be recorded at multiple perioperative intervals, and surgical cancellation rates, satisfaction levels will be noted, surgical duration, and hospital stay will be documented.
Read the detailed description
Intranasal Administration Technique:
- Intranasal dexmedetomidine (1 mcg/kg ideal body weight) will be diluted to a total volume of 1 ml.
- A mucosal atomization device (MAD) will be used for administration.
- The dose will be divided evenly, with 0.5 mL sprayed into each nostril while the patient is in a semi-recumbent position.
- The control group will receive an equivalent volume of 0.9% saline using the same method.
Local Anesthesia A peribulbar block will be administered with a mixture of lidocaine 2% and bupivacaine 0.5% (total volume: 5 mL).
The block will be performed under aseptic conditions by an experienced anesthesiologist.
- Conditions
- Cataract, Hypertension
- Being tested
- Intranasal dexmedetomidine, Intranasal normal saline
- Keywords
- Cataract, Hypertension, Intranasal Dexmedetomidine, Elderly
- Medical subject headings
- Cataract, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intranasal dexmedetomidineDrug
Intranasal dexmedetomidine (1 mcg/kg ideal body weight) will be diluted to a total volume of 1 ml and will be administered via a mucosal atomization device (MAD) 30 minutes before surgery. The dose will be divided evenly, with 0.5 mL sprayed into each nostril while the patient is in a semi-recumbent position.
Intranasal normal salineDrug
Intranasal normal saline (1 ml) will be administered via mucosal atomization device (MAD) 30 minutes before surgery. The dose will be divided evenly, with 0.5 mL sprayed into each nostril while the patient is in a semi-recumbent position.
| Study group | Role | What they receive |
|---|---|---|
| Dexmedetomidine group (Study group) | Active comparator | In this group, Dexmedetomidine (1 mcg/kg ideal body weight) will be administered intranasally 30 minutes before surgery. Receives: Drug: Intranasal dexmedetomidine |
| Placebo group (Control group) | Placebo comparator | In this group, Normal Saline will be administered intranasally 30 minutes before surgery. Receives: Drug: Intranasal normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean arterial blood pressure (MAP)
Mean arterial blood pressure (MAP), measured in mmHg, will be recorded in both groups at the following time points:
- Preoperative baseline
- Every 5 minutes after intranasal drug administration
- Intraoperative baseline
- Immediately after peribulbar block
- Every 5 minutes after the block until the end of the surgery
- Every 15 minutes postoperatively until discharge
Measured: From preoperative baseline until 2 hours postoperatively
Secondary outcomes (6)
Surgical cancellation rate
The number and percentage of cases in each group in which cataract surgery will be cancelled due to uncontrolled blood pressure, inadequate sedation, patient anxiety, or any other reason
Measured: From the preoperative period until completion or cancellation of the surgery
Sedation score using the Modified Observer's Assessment of Alertness/Sedation Scale (MOAA/S).
Sedation will be evaluated using the MOAA/S scale at predefined time points:
- Every 5 minutes after intranasal drug administration
- Intraoperative baseline
- Immediately after peribulbar block
- Every 5 minutes after the block until the end of the surgery
- Every 15 minutes postoperatively until discharge
The MOAA/S is a scale from 0 to 5 assessing a subject's responsiveness to verbal and physical stimuli as follows:
0: No response after painful stimuli
- Responds only after painful trapezius squeeze
- Responds only after mild prodding or shaking
- Responds only after name is called loudly and/or repeatedly
- Lethargic response to name spoken in normal tone
- Responds readily to name spoken in normal tone
Measured: From preoperative drug administration until 2 hours postoperatively
Heart rate (HR)
Heart rate (HR) will be recorded in both groups at the following time points:
- Preoperative baseline
- Every 5 minutes after intranasal drug administration
- Intraoperative baseline
- Immediately after peribulbar block
- Every 5 minutes after the block until the end of the surgery
- Every 15 minutes postoperatively until discharge
Measured: From preoperative baseline until 2 hours postoperatively
Patient Satisfaction
Patient satisfaction with anesthesia care was measured using the Iowa Satisfaction with Anesthesia Scale (ISAS), a validated instrument specifically designed for monitored anesthesia care and sedation. The ISAS consists of 11 items rated on a 6-point Likert scale, with both positively and negatively worded statements. The total score was calculated as the mean of all items after appropriate reverse coding, with higher scores indicating greater satisfaction.
Measured: Assessed once the patient is in the post-anesthesia care unit (PACU) prior to discharge
Anesthesiologist Satisfaction
Anesthesiologist Satisfaction will be evaluated using structured 5 point Likert scale (1 = very dissatisfied, 5 = very satisfied). The assessment includes adequacy of sedation, ease of patient management, hemodynamic stability, airway safety, and overall satisfaction. A composite score will be calculated as the mean of all items, with higher scores indicating greater satisfaction.
Measured: Assessed immediately after completion of the procedure
Surgeon Satisfaction
Surgeon satisfaction was assessed using a structured 5-point Likert scale (1 = very dissatisfied, 5 = very satisfied). The assessment included surgical field conditions, patient cooperation, ocular stability, ease of performing the procedure, and overall satisfaction. A composite score will be calculated as the mean of all items, with higher scores indicating greater satisfaction.
Measured: Assessed immediately after completion of the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2025
- Study start16 Jul 2025
- Primary completionApr 2026 (estimated)
- Study completionMay 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for CataractStudies of the same condition, open and under way.
- More trials run by Suez Canal UniversityThe sponsor's other registered studies.
- 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
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 126 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Suez Canal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammad E Salama, MD, Suez Canal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07080229
- Sponsor's protocol ID
- 5989#
- Status last verified
- Aug 2025
- First submitted
- 14 Jul 2025
- Last updated
- 7 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Wang K, Wu M, Xu J, Wu C, Zhang B, Wang G, Ma D. Effects of dexmedetomidine on perioperative stress, inflammation, and immune function: systematic review and meta-analysis. Br J Anaesth. 2019 Dec;123(6):777-794. doi: 10.1016/j.bja.2019.07.027. Epub 2019 Oct 24.
PubMed 31668347Liu S, Wang Y, Zhu Y, Yu T, Zhao H. Safety and sedative effect of intranasal dexmedetomidine in mandibular third molar surgery: a systematic review and meta-analysis. Drug Des Devel Ther. 2019 Apr 23;13:1301-1310. doi: 10.2147/DDDT.S194894. eCollection 2019.
PubMed 31114165Xu X, Cao Y, Wu Y, Ding M. Intranasal Dexmedetomidine in Elderly Patients (Aged > 65 Years) During Maxillofacial Surgery: Sedative Properties and Safety Analysis. J Oral Maxillofac Surg. 2022 Mar;80(3):443-455. doi: 10.1016/j.joms.2021.10.013. Epub 2021 Oct 30.
PubMed 34838503Li A, Yuen VM, Goulay-Dufay S, Sheng Y, Standing JF, Kwok PCL, Leung MKM, Leung AS, Wong ICK, Irwin MG. Pharmacokinetic and pharmacodynamic study of intranasal and intravenous dexmedetomidine. Br J Anaesth. 2018 May;120(5):960-968. doi: 10.1016/j.bja.2017.11.100. Epub 2018 Feb 2.
PubMed 29661413Fleisher LA, Fleischmann KE, Auerbach AD, Barnason SA, Beckman JA, Bozkurt B, Davila-Roman VG, Gerhard-Herman MD, Holly TA, Kane GC, Marine JE, Nelson MT, Spencer CC, Thompson A, Ting HH, Uretsky BF, Wijeysundera DN. 2014 ACC/AHA guideline on perioperative cardiovascular evaluation and management of patients undergoing noncardiac surgery: executive summary: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. Circulation. 2014 Dec 9;130(24):2215-45. doi: 10.1161/CIR.0000000000000105. Epub 2014 Aug 1. No abstract available.
PubMed 25085962Fang R, Yu YF, Li EJ, Lv NX, Liu ZC, Zhou HG, Song XD. Global, regional, national burden and gender disparity of cataract: findings from the global burden of disease study 2019. BMC Public Health. 2022 Nov 12;22(1):2068. doi: 10.1186/s12889-022-14491-0.
PubMed 36369026
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Intranasal Dexmedetomidine Compared to Placebo on Blood Pressure in Elderly Hypertensive Patients Undergoing Cataract Surgery: A Double-Blind Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07080229
- Acronym / sponsor ID
- 5989#
- Conditions
- Cataract, Hypertension
- Keywords
- Cataract, Hypertension, Intranasal Dexmedetomidine, Elderly
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 126 participants (estimated)
- Lead sponsor
- Suez Canal UniversityUniversity, hospital or other
- Study start
- 16 Jul 2025 (actual)
- Primary completion
- Apr 2026 (estimated)
- Study completion
- May 2026 (estimated)
- First posted
- 23 Jul 2025 (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.
Cataract surgery in elderly patients with controlled hypertension carries a risk of hemodynamic instability, particularly fluctuations in mean arterial blood pressure (MAP). Dexmedetomidine, a selective α2-adrenergic agonist, offers hemodynamic stabilization and sedation when administered intranasally and provides a simple and non-invasive premedication option.
This study evaluates the effects of intranasal dexmedetomidine on perioperative mean arterial blood pressure in patients undergoing cataract surgeries.
Research Question:
Does intranasal dexmedetomidine premedication control blood pressure in elderly hypertensive patients undergoing cataract surgery?
Research Hypothesis:
Intranasal dexmedetomidine significantly reduces MAP and improves secondary outcomes compared to placebo.
Primary Objective: To evaluate the efficacy of intranasal Dexmedetomidine as a premedication to control hypertension in elderly patients scheduled for cataract surgery.
Secondary Objectives: 1. To assess surgery cancellation rates. 2. To evaluate satisfaction levels among patients, anesthesiologists, and surgeons using the Modified Observer's assessment of alertness/sedation scale (MOAA/S). 3- To evaluate the effect of intranasal dexmedetomidine on HR multiple readings starting from preoperative hold area till 2 hours postoperatively.
This randomized, double-blinded clinical trial will include 126 elderly hypertensive patients (≥65 years) undergoing cataract surgery under local anesthesia. Inclusion Criteria will consist of patients aged ≥65 years, ASA II or III, stage 2 hypertension as per ACC / AHA guidelines (SBP>140 and DBP> 90 mmHg), undergoing elective cataract surgery under local anesthesia. Exclusion Criteria will include allergy or contraindication to dexmedetomidine, significant baseline bradycardia (<50 bpm) or arrhythmia, use of sedative or anxiolytic medications, history of severe hepatic, renal, or cerebrovascular disease. Participants will be randomly assigned to receive either intranasal dexmedetomidine (1 mcg/kg ideal body weight) or a placebo (normal saline) 30 minutes before surgery. MAP, HR, and SpO₂ will be recorded at multiple perioperative intervals, and surgical cancellation rates, satisfaction levels will be noted, surgical duration, and hospital stay will be documented.
Detailed description
Intranasal Administration Technique:
- Intranasal dexmedetomidine (1 mcg/kg ideal body weight) will be diluted to a total volume of 1 ml.
- A mucosal atomization device (MAD) will be used for administration.
- The dose will be divided evenly, with 0.5 mL sprayed into each nostril while the patient is in a semi-recumbent position.
- The control group will receive an equivalent volume of 0.9% saline using the same method.
Local Anesthesia A peribulbar block will be administered with a mixture of lidocaine 2% and bupivacaine 0.5% (total volume: 5 mL).
The block will be performed under aseptic conditions by an experienced anesthesiologist.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dexmedetomidine group (Study group) | Active comparator | Drug: Intranasal dexmedetomidineIn this group, Dexmedetomidine (1 mcg/kg ideal body weight) will be administered intranasally 30 minutes before surgery. |
| Placebo group (Control group) | Placebo comparator | Drug: Intranasal normal salineIn this group, Normal Saline will be administered intranasally 30 minutes before surgery. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- Patients aged ≥65 years.
- Patients who will have stage 2 hypertension as per ACC/AHA guidelines (Systolic BP > 140 and Diastolic BP> 90 mmHg)
- Elective cataract surgery under local anesthesia.
- American Society of Anesthesiologists (ASA) physical status II or III.
Key exclusion criteria (4 listed)
- Allergy or contraindication to dexmedetomidine.
- Significant baseline bradycardia (<50 bpm) or arrhythmias.
- Use of sedative or anxiolytic medications.
- History of severe hepatic, renal, or cerebrovascular diseases.
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 |
|---|---|---|
| Intranasal dexmedetomidineIntranasal dexmedetomidine (1 mcg/kg ideal body weight) will be diluted to a total volume of 1 ml and will be administered via a mucosal atomization device (MAD) 30 minutes before surgery. The dose will be divided evenly, with 0.5 mL sprayed into each nostril while the patient is in a semi-recumbent position. | Drug | Dexmedetomidine group (Study group) |
| Intranasal normal salineIntranasal normal saline (1 ml) will be administered via mucosal atomization device (MAD) 30 minutes before surgery. The dose will be divided evenly, with 0.5 mL sprayed into each nostril while the patient is in a semi-recumbent position. | Drug | Placebo group (Control group) |
Primary outcome
Mean arterial blood pressure (MAP)
Time frame: From preoperative baseline until 2 hours postoperatively
Mean arterial blood pressure (MAP), measured in mmHg, will be recorded in both groups at the following time points: * Preoperative baseline * Every 5 minutes after intranasal drug administration * Intraoperative baseline * Immediately after peribulbar block * Every 5 minutes after the block until the end of the surgery * Every 15 minutes postoperatively until discharge
6 secondary outcomes
Surgical cancellation rate
Time frame: From the preoperative period until completion or cancellation of the surgery
Sedation score using the Modified Observer's Assessment of Alertness/Sedation Scale (MOAA/S).
Time frame: From preoperative drug administration until 2 hours postoperatively
Heart rate (HR)
Time frame: From preoperative baseline until 2 hours postoperatively
Patient Satisfaction
Time frame: Assessed once the patient is in the post-anesthesia care unit (PACU) prior to discharge
Anesthesiologist Satisfaction
Time frame: Assessed immediately after completion of the procedure
Surgeon Satisfaction
Time frame: Assessed immediately after completion of the procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2026.
- Results publication: PubMed 31668347Wang K, Wu M, Xu J, Wu C, Zhang B, Wang G, Ma D. Effects of dexmedetomidine on perioperative stress, inflammation, and immune function: systematic review and meta-analysis. Br J Anaesth. 2019 Dec;123(6):777-794. doi: 10.1016/j.bja.2019.07.027. Epub 2019 Oct 24.
- Results publication: PubMed 31114165Liu S, Wang Y, Zhu Y, Yu T, Zhao H. Safety and sedative effect of intranasal dexmedetomidine in mandibular third molar surgery: a systematic review and meta-analysis. Drug Des Devel Ther. 2019 Apr 23;13:1301-1310. doi: 10.2147/DDDT.S194894. eCollection 2019.
- Results publication: PubMed 34838503Xu X, Cao Y, Wu Y, Ding M. Intranasal Dexmedetomidine in Elderly Patients (Aged > 65 Years) During Maxillofacial Surgery: Sedative Properties and Safety Analysis. J Oral Maxillofac Surg. 2022 Mar;80(3):443-455. doi: 10.1016/j.joms.2021.10.013. Epub 2021 Oct 30.
- Results publication: PubMed 29661413Li A, Yuen VM, Goulay-Dufay S, Sheng Y, Standing JF, Kwok PCL, Leung MKM, Leung AS, Wong ICK, Irwin MG. Pharmacokinetic and pharmacodynamic study of intranasal and intravenous dexmedetomidine. Br J Anaesth. 2018 May;120(5):960-968. doi: 10.1016/j.bja.2017.11.100. Epub 2018 Feb 2.
- Results publication: PubMed 25085962Fleisher LA, Fleischmann KE, Auerbach AD, Barnason SA, Beckman JA, Bozkurt B, Davila-Roman VG, Gerhard-Herman MD, Holly TA, Kane GC, Marine JE, Nelson MT, Spencer CC, Thompson A, Ting HH, Uretsky BF, Wijeysundera DN. 2014 ACC/AHA guideline on perioperative cardiovascular evaluation and management of patients undergoing noncardiac surgery: executive summary: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. Circulation. 2014 Dec 9;130(24):2215-45. doi: 10.1161/CIR.0000000000000105. Epub 2014 Aug 1. No abstract available.
- Results publication: PubMed 36369026Fang R, Yu YF, Li EJ, Lv NX, Liu ZC, Zhou HG, Song XD. Global, regional, national burden and gender disparity of cataract: findings from the global burden of disease study 2019. BMC Public Health. 2022 Nov 12;22(1):2068. doi: 10.1186/s12889-022-14491-0.
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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.
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 Intranasal dexmedetomidine and Intranasal normal saline in people with Cataract and Hypertension, run by Suez Canal University at 1 site in Egypt.
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 4 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 7 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 Egypt. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mohammad E Salama, MD (+201016865861, MohammadElhossieny88@med.suez.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean arterial blood pressure (MAP) (time frame: From preoperative baseline until 2 hours postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07080229, which also lists 6 linked publications.
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 7 Apr 2026.