Preoperative Ivabradine Doses for Hemodynamic Stability in FESS

ConditionHemodynamic Instability

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age21-60

SponsorMinia University

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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)

Trial design

Design model

Parallel

Treatments tested in this trial

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.

Treatment groups

60 Participants

are divided into 3 treatment groups

Group A: Group A: Ivabradine 5 mg/5 mgExperimental treatment 1 intervention

Group B: Group B: Ivabradine 5 mg/7.5 mgExperimental treatment 1 intervention

Group C: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

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)

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Minia University

Lead sponsor

Source ClinicalTrials.gov

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