An interventional study of Ivabradine 5 mg/5 mg regimen and Ivabradine 5 mg/7.5 mg regimen in Hemodynamic Instability, sponsored by Minia University. Not yet recruiting. Open to participants aged 21 Years to 60 Years. Per ClinicalTrials.gov, last updated 2026-09-01.
Sponsored by Minia University · Not applicable, Interventional, and Prevention
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
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.
Exclusion Criteria:
Patients received oral ivabradine 5 mg the night before surgery and an additional 5 mg on the morning of surgery.
Drug: Ivabradine 5 mg/5 mg regimen
Patients received oral ivabradine 5 mg the night before surgery and an additional 7.5 mg on the morning of surgery.
Drug: Ivabradine 5 mg/7.5 mg regimen
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.
Drug: Placebo
Oral ivabradine 5 mg administered the night before surgery, followed by an additional 5 mg on the morning of surgery.
Oral ivabradine 5 mg administered the night before surgery, followed by an additional 7.5 mg on the morning of surgery.
Oral placebo (folic acid) administered the night before surgery and on the morning of surgery, following the same schedule as the treatment groups.
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.
Time frame: 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.
Time frame: Intraoperative, from induction of anesthesia through end of surgery (approximately 60-90 minutes)
No study locations are listed for this record.
Plan to share: Undecided
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Minia University