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
1 other identifier
interventional
60
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Oct 2020
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 30, 2020
CompletedFirst Posted
Study publicly available on registry
October 8, 2020
CompletedStudy Start
First participant enrolled
October 15, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
January 30, 2021
CompletedOctober 14, 2020
October 1, 2020
3 months
September 30, 2020
October 12, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
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
Study Arms (2)
Ivabradine group
EXPERIMENTALpropranolol group
EXPERIMENTALInterventions
Ivabradine group will receive ivabradine 5mg PO in the evening and 1 hour before anesthetic induction
propranolol group will receive propranolol 10 mg PO in the evening and 1 hour before anesthetic induction.
Eligibility Criteria
You may qualify if:
- Age of 18 - 60 years.
- Patients of both genders.
- ASA grade I - II .
You may not qualify if:
- Patient refusal.
- Any contraindication to medication included in the study .
- Patients with allergy to medication included in the study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Ahmed Talaat Ahmed
Asyut, Egypt
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ahmed T Ahmed, A professor
Assiut University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- clinical professor
Study Record Dates
First Submitted
September 30, 2020
First Posted
October 8, 2020
Study Start
October 15, 2020
Primary Completion
January 1, 2021
Study Completion
January 30, 2021
Last Updated
October 14, 2020
Record last verified: 2020-10
Data Sharing
- IPD Sharing
- Will not share