Ivabradine Versus Propranolol for Induced Hypotension in Endoscopic Sinus Surgery

Comparative Study Between Oral Ivabradine Versus Oral Propranolol for Induced Hypotension in Functional Endoscopic Sinus Surgery

the study is designed to compare the effect of addition of oral Ivabradine, propranolol to general anesthesia aimed reduction in blood loss during functional endoscopic sinus surgery.

Study Overview

• Status: Unknown
• Conditions: Hypotension
• Intervention / Treatment: Drug: oral Ivabradine; Drug: oral Propranolol

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Amal A Mohamed; Phone Number: 0102 175 9992; Email: amalabdelnasser28@gmail.com
• Study Contact Backup: Name: Ahmed T Ahmed, A professor; Phone Number: 01062716629; Email: talaat83@aun.edu.eg

Study Locations

• Egypt
  • Assiut, Egypt
    • Recruiting
    • Ahmed Talaat Ahmed
    • Contact: Amal A Mohamed; Phone Number: 0102 175 9992; Email: amalabdelnasser28@gmail.com
    • Contact: Ahmed T Ahmed, A professor; Phone Number: 01062716629; Email: talaat83@aun.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Age of 18 - 60 years.
• Patients of both genders.
• ASA grade I - II .

Exclusion Criteria:

• Patient refusal.
• Any contraindication to medication included in the study .
• Patients with allergy to medication included in the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ivabradine group	Drug: oral Ivabradine; Ivabradine group will receive ivabradine 5mg PO in the evening and 1 hour before anesthetic induction
Experimental: propranolol group	Drug: oral Propranolol; propranolol group will receive propranolol 10 mg PO in the evening and 1 hour before anesthetic induction.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
change in blood loss	Estimated blood loss in millilitres per hour is calculated by subtracting the volume of total irrigation used during the case from the total amount of fluid in the suction canister at the end of surgery in addition, pre-weighing and post-weighing of sponges and oropharyngeal packs were also done and dividing by surgical time in hours. assessment of blood loss by Boezaart and van der Merwe Grading System for bleeding during Endoscopic Sinus Surgery	immediately after the surgery

Collaborators and Investigators

• Sponsor: Ahmed talaat ahmed aly
• Investigators: Principal Investigator: Ahmed T Ahmed, A professor, Assiut University

Study record dates

Study Major Dates

• Study Start (Anticipated): October 15, 2020
• Primary Completion (Anticipated): January 1, 2021
• Study Completion (Anticipated): January 30, 2021

Study Registration Dates

• First Submitted: September 30, 2020
• First Submitted That Met QC Criteria: October 6, 2020
• First Posted (Actual): October 8, 2020

Study Record Updates

• Last Update Posted (Actual): October 14, 2020
• Last Update Submitted That Met QC Criteria: October 12, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypotension; Physiological Effects of Drugs; Adrenergic beta-Antagonists; Adrenergic Antagonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Antihypertensive Agents; Vasodilator Agents; Propranolol
• Other Study ID Numbers: ivabradine versus propranolol

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No