Ivabradine 5 mg/5 mg regimen
DrugOral ivabradine 5 mg administered the night before surgery, followed by an additional 5 mg on the morning of surgery.
NCT Number: NCT07797946
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
Trial opening soon.
Get Notified21 year–60 year
All sexes
Interventional
Not applicable
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
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.
Trial opening soon.
Get NotifiedMinia University
Other
Comparison of Two Preoperative Ivabradin Regimens for Hemodynamic Stability During Functional Endoscopic Sinus Surgery
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