Preoperative Ivabradine Doses for Hemodynamic Stability in FESS

NCT07797946 | Not Yet Recruiting

• 1 other identifier: MUFMIRB 2054/7/2026
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief 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. 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

Conditions

Hemodynamic Instability

Keywords

Ivabradine • Functional Endoscopic Sinus Surgery • Controlled Hypotension • Heart Rate

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  Intraoperative, from induction of anesthesia through end of surgery (approximately 60-90 minutes)

Study Arms (3)

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.

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.

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.

Drug: Placebo

Interventions

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.

Group A: Ivabradine 5 mg/5 mg

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.

Group B: Ivabradine 5 mg/7.5 mg

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.

Placebo

Eligibility Criteria

• Age: 21 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Minia University: lead

MeSH Terms

Interventions

Ivabradine; Clinical Protocols

Intervention Hierarchy (Ancestors)

Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Therapeutics; Epidemiologic Study Characteristics; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation

Central Study Contacts

yahia Magdi Mohamed, Resident in Anesthesia

CONTACT

0201112072006; magdiyahia6@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Randomization codes were concealed in sequentially numbered opaque sealed envelopes, and study medications were prepared by an independent pharmacist not otherwise involved in the study."
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physician, Department of Anesthesia, Intensive Care and Pain Management, Faculty of Medicine, Minia University

Study Record Dates

• First Submitted: August 21, 2026
• First Posted: September 1, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): February 1, 2027
• Last Updated: September 1, 2026

Record last verified: 2026-08