Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Ivabradine Versus Propranolol for Induced Hypotension in Endoscopic Sinus Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04580342
Recruitment Status : Recruiting
First Posted : October 8, 2020
Last Update Posted : October 14, 2020
Sponsor:
Information provided by (Responsible Party):
Ahmed talaat ahmed aly, Assiut University

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Hypotension Drug: oral Ivabradine Drug: oral Propranolol Phase 2

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Comparative Study Between Oral Ivabradine Versus Oral Propranolol for Induced Hypotension in Functional Endoscopic Sinus Surgery
Estimated Study Start Date : October 15, 2020
Estimated Primary Completion Date : January 1, 2021
Estimated Study Completion Date : January 30, 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. change in blood loss [ Time Frame: immediately after the surgery ]

    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



Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04580342


Contacts
Layout table for location contacts
Contact: Ahmed T Ahmed, A professor 01062716629 talaat83@aun.edu.eg
Contact: Amal A Mohamed 0102 175 9992 amalabdelnasser28@gmail.com

Locations
Layout table for location information
Egypt
Ahmed Talaat Ahmed Recruiting
Assiut, Egypt
Contact: Ahmed T Ahmed, A professor    01062716629    talaat83@aun.edu.eg   
Contact: Amal A Mohamed    0102 175 9992    amalabdelnasser28@gmail.com   
Sponsors and Collaborators
Ahmed talaat ahmed aly
Investigators
Layout table for investigator information
Principal Investigator: Ahmed T Ahmed, A professor Assiut University
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Ahmed talaat ahmed aly, clinical professor, Assiut University
ClinicalTrials.gov Identifier: NCT04580342    
Other Study ID Numbers: ivabradine versus propranolol
First Posted: October 8, 2020    Key Record Dates
Last Update Posted: October 14, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Hypotension
Vascular Diseases
Cardiovascular Diseases
Propranolol
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
 Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Antihypertensive Agents
Vasodilator Agents