Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202111574906850 Date of Approval: 02/11/2021
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Comparing the effect of oral ivabradine versus oral propranolol premedication during controlled hypotensive anesthesia in functional endoscopic sinus surgery
Official scientific title Comparing the effect of oral ivabradine versus oral propranolol premedication during controlled hypotensive anesthesia in functional endoscopic sinus surgery
Brief summary describing the background and objectives of the trial Functional Endoscopic Sinus Surgery (FESS) is the cornerstone therapeutic management for nasal pathologies . Intraoperative bleeding causing poor visibility of surgical field is of major concern during FESS. Hypotensive anesthesia is one modilty for control and reduction of bleeding during FESS. Reflex tachycardia occur during hypotensive anesthesia increase risk of intraoperative bleedind and increase duration of surgery So, premedication with drugs that control heart rate such as Beta-blockers and Ivabradine (highly selective inhibitor of If channels) will be helpful during hypotensive anesthesia.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Anaesthesia
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 25/10/2021
Actual trial start date 01/11/2021
Anticipated date of last follow up 25/10/2021
Actual Last follow-up date 01/11/2022
Anticipated target sample size (number of participants) 40
Actual target sample size (number of participants) 40
Recruitment status Recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using a randomization table created by a computer software program Allocation was determined by the holder of the sequence who is situated off site Masking/blinding used Outcome Assessors,Participants
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using a randomization table created by a computer software program Sealed opaque envelopes Masking/blinding used Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Ivabradine 5 mg At 8:00 pm in the evening before the day of the surgery and one 5 mg tablet one hour before the induction of anesthesia. GROUP (I): will receive oral ivabradine (Procoralan ) 5 mg one tablet at 8:00 pm in the evening before the day of the surgery and one 5 mg tablet one hour before the induction of anesthesia. 20
Control Group Propranolol 10 mg one tablet at 8:00 pm in the evening before the day of the surgery and one tablet one hour before the induction of anesthesia GROUP (P): will receive oral propranolol (INDERAL -propranolol hydrochloride ) 10 mg one tablet at 8:00 pm in the evening before the day of the surgery and one 10 mg tablet one hour before the induction of anesthesia 20 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
o ASA physical status I and II. o Age group: 18-40 years old. o Patients with cardiovascular disease (hypertension , congestive heart failure , coronary artery disease , AF). o Patients on beta-blockers. o Patients with baseline heart rate < 60 beats per minute. o Patients with diabetes mellitus (DM). o Cerebrovascular insufficiency. o Coagulation defects. o History of renal or hepatic insufficiency. o Hypersensitivity to the study drugs. o Patients with history of bronchial asthema. Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year 18 Year(s) 40 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 18/11/2020 Research Ethics Committee at faculty of medicine Ain shams university
Ethics Committee Address
Street address City Postal code Country
Abbasya , Cairo, Egypt Abbasya 11517 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Hemodynamic variables: o Mean arterial blood pressure (MABP) in mmHg by non- invasive monitoring . o Heart rate: (beats / minute) . Baseline before induction of anesthesia. - Every 30 min throughout deliberate hypotension till termination of NTG infusion. - 5 minutes after the end of deliberate hypotension
Primary Outcome Amount of Blood loss Intraoperative bleedi The procedure time
Secondary Outcome The amount of nitroglycerin used Through out deliberate hypotension
Secondary Outcome Incidence of Complications The procedure time
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Ain shams universiy El-Khalyfa El-Mamoun Street Abbasya, Cairo , Eygpt Abbasya 11517 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Mostafa Abdallah Lotfy Al khankah , Qalyubia , Egypt Al Khankha 13763 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Ain shams university El-Khalyfa El-Mamoun Street Abbasya, Cairo , Eygpt Abbasya 11517 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Ain shams university El-Khalyfa El-Mamoun Street Abbasya, Cairo , Eygpt Abbasya 11517 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Mostafa Abdallah dr.mostafaabdallah90@gmail.com 01066577600 Al khankah , Qalyubiyah , Egypt
City Postal code Country Position/Affiliation
Al khankah 13763 Egypt Assistant Lecturer
Role Name Email Phone Street address
Public Enquiries Mostafa Abdallah dr.mostafaabdallah90@gmail.com 01066577600 Al khankah , Qalyubiya , Egypt
City Postal code Country Position/Affiliation
Al khankah 13763 Egypt Assistant lecturer
Role Name Email Phone Street address
Scientific Enquiries Mostafa Abdallah dr.mostafaabdallah90@gmail.com 01066577600 Al Khankha , Qalyuibya , Egypt
City Postal code Country Position/Affiliation
Al Khankha 13763 Egypt Assistant Lecturer
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant data that underlie the results reported in this article , after deidentification Study Protocol Immediately following publiation No end date Any one who wishes to access the data For any purpose Data will be available indefinitely at https://asja.springeropen.com/
URL Results Available Results Summary Result Posting Date First Journal Publication Date
https://asja.springeropen.com/ No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information