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.: PACTR202202877370804 Date of Approval: 09/02/2022
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title A comparison between propofol, dexmeditomedine and nitroglycerin as hypotensive agents and their effect on blood loss in functional endoscopic sinus surgery (FESS)
Official scientific title A comparison between propofol, dexmeditomedine and nitroglycerin as hypotensive agents and their effect on blood loss in functional endoscopic sinus surgery (FESS)
Brief summary describing the background and objectives of the trial There are several important advantages of using the intentional hypotensive anesthetic technique during the FESS like reduction in blood loss, hence, reduction in blood transfusion rate, improvement in the surgical field, and reduction of the duration of surgery. This study aims to compare the effect of propofol ,dexmeditomedine and nitroglycerin as hypontensive agents in FESS and their effect on decreasing blood loss during surgery.
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 12/08/2019
Actual trial start date 12/08/2019
Anticipated date of last follow up 11/08/2020
Actual Last follow-up date 11/08/2020
Anticipated target sample size (number of participants) 60
Actual target sample size (number of participants) 60
Recruitment status Completed
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
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously 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
Control Group Group P propofol infusion 10mg/Kg/hr IV 90 minutes patients will receive propofol infusion 10mg/Kg/hr IV after induction of anesthesia 20 Active-Treatment of Control Group
Experimental Group Group D loading dose of 1 mcg/kg over 10 (on 100ml normal saline) before induction followed by a maintenance infusion of 0.5mcg/kg/hr. 90 minutes patients will receive loading dose of 1 mcg/kg over 10 (on 100ml normal saline) before induction followed by a maintenance infusion of 0.5mcg/kg/hr. 20
Experimental Group Group N nitroglycerin infusion 5μg/kg/min. 90 minutes patients received nitroglycerin infusion 5μg/kg/min after induction of anesthesia. 20
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
both sexes aging 20-50 years old ASA physical status I – II -Patient refusal -Pregnant females -Patients with pulmonary diseases, ischemic cardiovascular disease, ischemic cerebrovascular disease, hepatic disease, renal disease, diabetes mellitus, coagulopathies /and anemia -Patients with uncontrolled hypertension -patients with first, second or third heart block Adult: 19 Year-44 Year 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
Yes 09/09/2018 Research Ethics Committee at Faculty of medicine Ain Shams university
Ethics Committee Address
Street address City Postal code Country
Ramsis street, Abbassia square cairo 11591 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The primary outcome measurement was to compare the efficacy of dexmedetomidine , propofol and nitroglycerine in inducing controlled hypotension and the time needed in every group to obtain the targeted blood pressure. baseline and after 15,30,45,60,75,90 minutes
Secondary Outcome The secondary outcome measurements were controlling heart rate, inducing bloodless surgical field for better exposure and shorter duration of surgery during FESS. Baseline and after 15, 30, 45, 60, 75, 90 minutes
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Faculty of medicine Ain Shams university Ramsis street, Abbassia square cairo 11591 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Sarah Abdelrazzak Mohammed Saleh nasr city cairo 11765 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Faculty of medicine Ain Shams university Ramsis street, Abbassia square cairo 11591 Egypt University
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Public Enquiries Mohamed Elshorbagy dr.mohammedelshorbagy@gmail.com 00201227528857 Ramsis street
City Postal code Country Position/Affiliation
cairo 11591 Egypt lecturer of anesthiology at faculty of medicine Ain Shams university
Role Name Email Phone Street address
Scientific Enquiries Doaa Kamal El Din MKjamaluddeen@hotmail.com 00201005667050 Ramsis street
City Postal code Country Position/Affiliation
cairo 11591 Egypt Lecturer of anesthiology at faculty of medicine Ain Shams university
Role Name Email Phone Street address
Principal Investigator Sarah Saleh drsarahsaleh21@gmail.com 00201271631637 Ahmed Fakhry
City Postal code Country Position/Affiliation
cairo 11765 Egypt Assistant lecturer of anesthiology at faculty of medicine Ain Shams university
Role Name Email Phone Street address
Public Enquiries Adel Shenoda amikhaeal@hotmail.com 00201227817112 Ramsis street
City Postal code Country Position/Affiliation
cairo 11591 Egypt professor of anestiology at faculty of medicine Ain Shams university
Role Name Email Phone Street address
Scientific Enquiries Hala Salam drhalagomaa@gmail.com 00201224607707 Ramsis street
City Postal code Country Position/Affiliation
cairo 11591 Egypt profesor of anesthiology at faculty of medicine Ain Shams university
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes individual participation data will be available Study Protocol not applicable not applicable
URL Results Available Results Summary Result Posting Date First Journal Publication Date
not applicable Yes 05/02/2022
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result - 05/02/2022
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information