Hemodynamic InstabilityNCT07797946
Preoperative Ivabradine Doses for Hemodynamic Stability in FESS
A study testing Ivabradine 5 mg/5 mg regimen and Ivabradine 5 mg/7.5 mg regimen in people with Hemodynamic Instability, run by Minia University.
Trial summary
This study compares two different preoperative doses of a heart-rate-lowering medication called ivabradine in patients undergoing endoscopic sinus surgery under general anesthesia. Patients will receive either a lower dose, a higher dose, or a placebo (inactive pill) before surgery. Read more about this study
- Who is it for?
- Ages 21 to 60 years
- Conditions the study is for
- Hemodynamic Instability
- What is being tested?
- Ivabradine 5 mg/5 mg regimen and Ivabradine 5 mg/7.5 mg regimen
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2026to 1 Feb 2027
- Phase
- Interventional
- 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 21 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age between 21 and 60 years of both sexes
- ASA physical status I or II
- Baseline heart rate ≥ 70 beats per minute in sinus rhythm on preoperative ECG
Who cannot join
- Patient refusal or inability to provide informed consent
- Baseline heart rate <70 beats per minute or any degree of heart block on preoperative ECG
- Current use of beta blockers, calcium channel blockers, digoxin, or any antiarrhythmic agent
- Severe hepatic impairment (Child-Pugh class C) or renal impairment (eGFR<30 ml/min)
- Pregnancy or breastfeeding
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Comparison of Two Preoperative Ivabradin Regimens for Hemodynamic Stability During Functional Endoscopic Sinus Surgery
This study compares two different preoperative doses of a heart-rate-lowering medication called ivabradine in patients undergoing endoscopic sinus surgery under general anesthesia. Patients will receive either a lower dose, a higher dose, or a placebo (inactive pill) before surgery. The goal is to see which approach best keeps blood pressure and heart rate stable during surgery, and whether it reduces bleeding and improves the surge
Read the detailed description
This is a prospective, randomized, double-blind, placebo-controlled, parallel-group trial conducted at Minia University Hospital. Eighty-four patients aged 21-60 years, ASA physical status I or II, scheduled for functional endoscopic sinus surgery (FESS) under general anesthesia, with a baseline heart rate of 70 beats per minute or higher in sinus rhythm, will be randomly allocated into three equal groups. Group A will receive ivabradine 5 mg the night before surgery plus 5 mg on the morning of surgery; Group B will receive ivabradine 5 mg the night before plus 7.5 mg on the morning of surgery; Group C will receive a placebo (folic acid) on both occasions. Randomization codes will be concealed in sequentially numbered opaque sealed envelopes, and study medication will be prepared by an independent pharmacist to maintain blinding. Hemodynamic parameters will be recorded at standardized time points throughout the perioperative period. Surgical field visibility will be assessed using the Boezaart Bleeding Scale, and recovery will be assessed using the modified Aldrete Score. The study aims to determine which ivabradine regimen provides superior hemodynamic stability and surgical field conditions during FESS.
- Conditions
- Hemodynamic Instability
- Being tested
- Ivabradine 5 mg/5 mg regimen, Ivabradine 5 mg/7.5 mg regimen, Placebo
- Keywords
- Ivabradine • Functional Endoscopic Sinus Surgery • Controlled Hypotension • Heart Rate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ivabradine 5 mg/5 mg regimenDrug
Oral ivabradine 5 mg administered the night before surgery, followed by an additional 5 mg on the morning of surgery.
Ivabradine 5 mg/7.5 mg regimenDrug
Oral ivabradine 5 mg administered the night before surgery, followed by an additional 7.5 mg on the morning of surgery.
PlaceboDrug
Oral placebo (folic acid) administered the night before surgery and on the morning of surgery, following the same schedule as the treatment groups.
| Study group | Role | What they receive |
|---|---|---|
| Group A: Ivabradine 5 mg/5 mg | Experimental | Patients received oral ivabradine 5 mg the night before surgery and an additional 5 mg on the morning of surgery. Receives: Drug: Ivabradine 5 mg/5 mg regimen |
| Group B: Ivabradine 5 mg/7.5 mg | Experimental | Patients received oral ivabradine 5 mg the night before surgery and an additional 7.5 mg on the morning of surgery. Receives: Drug: Ivabradine 5 mg/7.5 mg regimen |
| Placebo | Placebo comparator | Patients received an oral placebo (folic acid) the night before surgery and on the morning of surgery, following the same schedule as the treatment groups. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraoperative Heart Rate Stability
Comparison of heart rate (beats per minute) at standardized intraoperative time points (T0-T10) across the three ivabradine dosing groups, to assess hemodynamic stability during FESS under general anesthesia.
Measured: Intraoperative, from induction of anesthesia through end of surgery (approximately 60-90 minutes)
Intraoperative Mean Arterial Pressure Stability
Comparison of mean arterial pressure (mmHg) at standardized intraoperative time points (T0-T10) across the three ivabradine dosing groups, to assess hemodynamic stability during FESS under general anesthesia.
Measured: Intraoperative, from induction of anesthesia through end of surgery (approximately 60-90 minutes)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2026
- Study start1 Aug 2026 (estimated)
- Primary completion1 Feb 2027 (estimated)
- Study completion1 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemodynamic InstabilityStudies of the same condition, open and under way.
- More trials run by Minia 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Minia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yahia Magdi Mohamed Ali, Minia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07797946
- Sponsor's protocol ID
- MUFMIRB 2054/7/2026
- Status last verified
- Aug 2026
- First submitted
- 21 Aug 2026
- Last updated
- 1 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Two Preoperative Ivabradin Regimens for Hemodynamic Stability During Functional Endoscopic Sinus Surgery
- ClinicalTrials.gov ID
- NCT07797946
- Acronym / sponsor ID
- MUFMIRB 2054/7/2026
- Conditions
- Hemodynamic Instability
- Keywords
- Ivabradine • Functional Endoscopic Sinus Surgery • Controlled Hypotension • Heart Rate
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Minia UniversityUniversity, hospital or other
- Study start
- 1 Aug 2026 (estimated)
- Primary completion
- 1 Feb 2027 (estimated)
- Study completion
- 1 Feb 2027 (estimated)
- First posted
- 1 Sep 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 study compares two different preoperative doses of a heart-rate-lowering medication called ivabradine in patients undergoing endoscopic sinus surgery under general anesthesia. Patients will receive either a lower dose, a higher dose, or a placebo (inactive pill) before surgery. The goal is to see which approach best keeps blood pressure and heart rate stable during surgery, and whether it reduces bleeding and improves the surge
Detailed description
This is a prospective, randomized, double-blind, placebo-controlled, parallel-group trial conducted at Minia University Hospital. Eighty-four patients aged 21-60 years, ASA physical status I or II, scheduled for functional endoscopic sinus surgery (FESS) under general anesthesia, with a baseline heart rate of 70 beats per minute or higher in sinus rhythm, will be randomly allocated into three equal groups. Group A will receive ivabradine 5 mg the night before surgery plus 5 mg on the morning of surgery; Group B will receive ivabradine 5 mg the night before plus 7.5 mg on the morning of surgery; Group C will receive a placebo (folic acid) on both occasions. Randomization codes will be concealed in sequentially numbered opaque sealed envelopes, and study medication will be prepared by an independent pharmacist to maintain blinding. Hemodynamic parameters will be recorded at standardized time points throughout the perioperative period. Surgical field visibility will be assessed using the Boezaart Bleeding Scale, and recovery will be assessed using the modified Aldrete Score. The study aims to determine which ivabradine regimen provides superior hemodynamic stability and surgical field conditions during FESS.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A: Ivabradine 5 mg/5 mg | Experimental | Drug: Ivabradine 5 mg/5 mg regimenPatients received oral ivabradine 5 mg the night before surgery and an additional 5 mg on the morning of surgery. |
| Group B: Ivabradine 5 mg/7.5 mg | Experimental | Drug: Ivabradine 5 mg/7.5 mg regimenPatients received oral ivabradine 5 mg the night before surgery and an additional 7.5 mg on the morning of surgery. |
| Placebo | Placebo comparator | Drug: PlaceboPatients received an oral placebo (folic acid) the night before surgery and on the morning of surgery, following the same schedule as the treatment groups. |
Who may qualify
- Ages
- 21 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Age between 21 and 60 years of both sexes
- ASA physical status I or II
- Baseline heart rate ≥ 70 beats per minute in sinus rhythm on preoperative ECG
Key exclusion criteria (5 listed)
- Patient refusal or inability to provide informed consent
- Baseline heart rate <70 beats per minute or any degree of heart block on preoperative ECG
- Current use of beta blockers, calcium channel blockers, digoxin, or any antiarrhythmic agent
- Severe hepatic impairment (Child-Pugh class C) or renal impairment (eGFR<30 ml/min)
- Pregnancy or breastfeeding
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 |
|---|---|---|
| Ivabradine 5 mg/5 mg regimenOral ivabradine 5 mg administered the night before surgery, followed by an additional 5 mg on the morning of surgery. | Drug | Group A: Ivabradine 5 mg/5 mg |
| Ivabradine 5 mg/7.5 mg regimenOral ivabradine 5 mg administered the night before surgery, followed by an additional 7.5 mg on the morning of surgery. | Drug | Group B: Ivabradine 5 mg/7.5 mg |
| PlaceboOral placebo (folic acid) administered the night before surgery and on the morning of surgery, following the same schedule as the treatment groups. | Drug | Placebo |
Primary outcome
Intraoperative Heart Rate Stability
Time frame: Intraoperative, from induction of anesthesia through end of surgery (approximately 60-90 minutes)
Comparison of heart rate (beats per minute) at standardized intraoperative time points (T0-T10) across the three ivabradine dosing groups, to assess hemodynamic stability during FESS under general anesthesia.
Intraoperative Mean Arterial Pressure Stability
Time frame: Intraoperative, from induction of anesthesia through end of surgery (approximately 60-90 minutes)
Comparison of mean arterial pressure (mmHg) at standardized intraoperative time points (T0-T10) across the three ivabradine dosing groups, to assess hemodynamic stability during FESS under general anesthesia.
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 1 Sep 2026.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Ivabradine 5 mg/5 mg regimen and Ivabradine 5 mg/7.5 mg regimen in people with Hemodynamic Instability, run by Minia University.
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 3 inclusion and 5 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: opening soon, as of the sponsor's last update on 1 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
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.
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 yahia Magdi Mohamed, Resident in Anesthesia (0201112072006, magdiyahia6@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intraoperative Heart Rate Stability (time frame: Intraoperative, from induction of anesthesia through end of surgery (approximately 60-90 minutes)). The study lists 2 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 1 Sep 2026.