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NCT04580342 Clinical Trial

Ivabradine Versus Propranolol for Induced Hypotension in Endoscopic Sinus Surgery

Hypotension Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04580342
Other study ID # ivabradine versus propranolol
Secondary ID
Status Recruiting
Phase Phase 2
First received
Last updated
Start date October 15, 2020
Est. completion date January 30, 2021

Study information
Verified date October 2020
Source Assiut University
Contact Ahmed T Ahmed, A professor
Phone 01062716629
Email talaat83@aun.edu.eg
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 60
Est. completion date January 30, 2021
Est. primary completion date January 1, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years to 60 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Drug:
• oral Ivabradine
Ivabradine group will receive ivabradine 5mg PO in the evening and 1 hour before anesthetic induction
• oral Propranolol
propranolol group will receive propranolol 10 mg PO in the evening and 1 hour before anesthetic induction.

Locations
Country Name City State
Egypt Ahmed Talaat Ahmed Assiut

Sponsors (1)
Lead Sponsor Collaborator
Ahmed talaat ahmed aly

Country where clinical trial is conducted

Egypt, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
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