Hemodynamic Instability
Conditions
Keywords
Ivabradine • Functional Endoscopic Sinus Surgery • Controlled Hypotension • Heart Rate
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
Detailed description
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.
Interventions
DRUGIvabradine 5 mg/5 mg regimen
Oral ivabradine 5 mg administered the night before surgery, followed by an additional 5 mg on the morning of surgery.
DRUGIvabradine 5 mg/7.5 mg regimen
Oral ivabradine 5 mg administered the night before surgery, followed by an additional 7.5 mg on the morning of surgery.
DRUGPlacebo
Oral placebo (folic acid) administered the night before surgery and on the morning of surgery, following the same schedule as the treatment groups.
Sponsors
Minia University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
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."
Eligibility
Sex/Gender
ALL
Age
21 Years to 60 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Intraoperative Heart Rate Stability | 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. |
| Intraoperative Mean Arterial Pressure Stability | 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. |
Contacts
CONTACTyahia Magdi Mohamed, Resident in Anesthesia
Outcome results
None listed