search
Back to results

Ivabradine Versus Propranolol for Induced Hypotension in Endoscopic Sinus Surgery

Primary Purpose

Hypotension

Status
Unknown status
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
oral Ivabradine
oral Propranolol
Sponsored by
Ahmed talaat ahmed aly
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hypotension

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Ahmed Talaat AhmedRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Ivabradine group

propranolol group

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
September 30, 2020
Last Updated
October 12, 2020
Sponsor
Ahmed talaat ahmed aly
search

1. Study Identification

Unique Protocol Identification Number
NCT04580342
Brief Title
Ivabradine Versus Propranolol for Induced Hypotension in Endoscopic Sinus Surgery
Official Title
Comparative Study Between Oral Ivabradine Versus Oral Propranolol for Induced Hypotension in Functional Endoscopic Sinus Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Unknown status
Study Start Date
October 15, 2020 (Anticipated)
Primary Completion Date
January 1, 2021 (Anticipated)
Study Completion Date
January 30, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Ahmed talaat ahmed aly

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypotension

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Ivabradine group
Arm Type
Experimental
Arm Title
propranolol group
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
oral Ivabradine
Intervention Description
Ivabradine group will receive ivabradine 5mg PO in the evening and 1 hour before anesthetic induction
Intervention Type
Drug
Intervention Name(s)
oral Propranolol
Intervention Description
propranolol group will receive propranolol 10 mg PO in the evening and 1 hour before anesthetic induction.
Primary Outcome Measure Information:
Title
change in blood loss
Description
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
Time Frame
immediately after the surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ahmed T Ahmed, A professor
Phone
01062716629
Email
talaat83@aun.edu.eg
First Name & Middle Initial & Last Name or Official Title & Degree
Amal A Mohamed
Phone
0102 175 9992
Email
amalabdelnasser28@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ahmed T Ahmed, A professor
Organizational Affiliation
Assiut University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ahmed Talaat Ahmed
City
Assiut
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ahmed T Ahmed, A professor
Phone
01062716629
Email
talaat83@aun.edu.eg
First Name & Middle Initial & Last Name & Degree
Amal A Mohamed
Phone
0102 175 9992
Email
amalabdelnasser28@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Ivabradine Versus Propranolol for Induced Hypotension in Endoscopic Sinus Surgery

We'll reach out to this number within 24 hrs