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NCT Number: NCT07797946

Preoperative Ivabradine Doses for Hemodynamic Stability in FESS

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

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Key information

Age range

21 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Ivabradine 5 mg/5 mg regimen

Drug

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 regimen

Drug

Oral ivabradine 5 mg administered the night before surgery, followed by an additional 7.5 mg on the morning of surgery.

Placebo

Drug

Oral placebo (folic acid) administered the night before surgery and on the morning of surgery, following the same schedule as the treatment groups.

Primary outcomes

  1. 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.

  2. 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.

Interested in participating?

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Sponsors and collaborators

Lead sponsor

Minia University

Other

Registry information

Official study title

Comparison of Two Preoperative Ivabradin Regimens for Hemodynamic Stability During Functional Endoscopic Sinus Surgery

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Sep 1, 2026
Registry last updated
Sep 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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