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.: PACTR201712002828410 Date of Approval: 30/11/2017
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Comparison between Phentolamine and Nitroglycerin for Controlled Hypotension during Functional Endoscopic Sinus Surgery (FESS)
Official scientific title Comparison between Phentolamine and Nitroglycerin for Controlled Hypotension during Functional Endoscopic Sinus Surgery (FESS)
Brief summary describing the background and objectives of the trial The aim and objective of this study is to compare the efficacy of controlled hypotensive anaesthesia with intravenous infusion of phentolamine versus nitroglycerine in patients undergoing Functional Endoscopic Sinus Surgery (FESS) as regarding intraoperative blood loss and hemodynamics stability.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Anaesthesia,Hypotensive Anesthesia,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Surgery
Anticipated trial start date 25/11/2017
Actual trial start date 16/12/2017
Anticipated date of last follow up 25/06/2018
Actual Last follow-up date 16/07/2018
Anticipated target sample size (number of participants) 30
Actual target sample size (number of participants) 30
Recruitment status Recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
Hatem Elmoutaz Mahmoud
Ahmed Goda Ahmed
Dina Mahmoud Fakhry
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 randomisation using a radomisation table created by a computer software program Sealed opaque envelopes Masking/blinding used Care giver/Provider
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Phentolamine 0.1-2 mg/min Till the end of surgery an infusion of Phentolamine will be started prior to surgical incision via syringe pump by adding 20 mg (2ml) of Phentolamine to 48 ml of normal saline making it to final concentration of 0.4 mg/ml at the rate of 0.1mg/min and will be titrated in between 0.1-2 mg/min according to the patients desired target blood pressure 15
Experimental Group Nitroglycerin 0.5-10 mcg/kg/min Till the end of surgery an infusion of Nitroglycerine will be started prior to surgical incision via syringe pump by adding 5mg (5ml) of Nitroglycerine to 45ml of normal saline making it to final concentration of 100¿g/ml at the rate of 0.5¿g/kg/min and will be titrated in between 0.5-10 ¿g/kg/min according to the patients desired target blood pressure 15
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
ASA grade I and II between the ages of 20-50 years BMI less than 30 kg/m2 ischemic heart diseases heart block congestive heart failure valvular heart diseases cerebrovascular diseases impaired kidney function history of chronic liver diseases uncontrolled hypertension asthma chronic obstructive lung diseases diabetes mellitus coagulation disorders pregnancy history of allergy to any drug substance abuse 20 Year(s) 50 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
No 14/12/2017 Research Ethical Committee Faculty of Medicine Beni Suef University
Ethics Committee Address
Street address City Postal code Country
Beni-Suef University Beni-Suef 62511 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome the achievement of controlled hypotension with MAP of 50-65 mmHg Every 5 minutes till termination of Anesthesia
Secondary Outcome blood loss Intraoperative
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Beni-Suef University hospital Beni-Suef Beni-Suef 62511 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
No Funding
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Dina Mahmoud Fakhry Beni-Suef Beni-Suef 62511 Egypt Hospital
COLLABORATORS
Name Street address City Postal code Country
Hatem Elmoutaz Mahmoud Beni-Suef Beni-Suef 62511 Egypt
Ahmed Goda Ahmed Beni-Suef Beni-Suef 62511 Egypt
Dina Mahmoud Fakhry Beni-Suef Beni-Suef 62511 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Dina Mahmoud dina_fakhry_91@yahoo.com 01289998680 Beni-Suef
City Postal code Country Position/Affiliation
Beni-Suef 62511 Egypt Resident of Anesthesia
Role Name Email Phone Street address
Public Enquiries Dina Mahmoud dina_fakhry_91@yahoo.com 01289998680 Beni-Suef
City Postal code Country Position/Affiliation
Beni-Suef 62511 Egypt Resident of Anesthesia
Role Name Email Phone Street address
Scientific Enquiries Dina Mahmoud dina_fakhry_91@yahoo.com 01289998680 Beni-Suef
City Postal code Country Position/Affiliation
Beni-Suef 62511 Egypt Resident of Anesthesia
REPORTING
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Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information