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.: PACTR201801002878287 Date of Approval: 15/12/2017
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Esmolol versus Dexmedetomidine for Deliberate Hypotension during Functional Endoscopic Sinus Surgery
Official scientific title Esmolol versus Dexmedetomidine for Deliberate Hypotension during Functional Endoscopic Sinus Surgery
Brief summary describing the background and objectives of the trial The aim of this study is to compare the hypotensive effect of esmolol and dexmedetomidine during functional endoscopic sinus surgery. After approval of the Ethical Committee at Menoufiya University Hospital, an informed written consent will be obtained from each patient. A pilot study had been carried out. Based on its results, the sample sizing assumed that the expected effect size for the amount of blood loss difference between the 2 groups is 40 ml and the standard deviation of outcome variable is 43. To achieve 80% power to detect this difference with a significance level of 5% it is estimated that 18 subjects per group would be required. With a withdrawal/non-evaluable subject rate of 10% a total of 21 per group subjects will be recruited leading to a total required sample size of 42 subjects. Patients will be randomly allocated into 2 groups, using envelope randomization method. Group E (n = 21) will receive esmolol 1 mg/kg IV over 1 minute, before induction of anesthesia, followed by 150-300 ¿g /Kg/min IV infusion during maintenance, to achieve a target MAP 55-65 mmHg. Group D (n = 21) will receive dexmedetomidine loading dose 1 ¿g/kg IV over 10 minute, before induction of anesthesia, followed by 0.4 ¿ 0.8 ¿g/kg/h IV infusion, during maintenance, to achieve a target MAP 55-65 mmHg.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Deliberate Hypotension during Functional Endoscopic Sinus Surgery,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 15/01/2018
Actual trial start date 15/01/2018
Anticipated date of last follow up 15/06/2018
Actual Last follow-up date 15/07/2018
Anticipated target sample size (number of participants) 36
Actual target sample size (number of participants) 36
Recruitment status Not yet 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 randomisation using a radomisation table created by a computer software program Sealed opaque envelopes Masking/blinding 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,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Group E esmolol 1 mg/kg IV over 1 minute, before induction of anesthesia, followed by 150-300 ¿g /Kg/min IV infusion during maintenance before induction of anesthesia, followed by infusion during maintenance 18 Active-Treatment of Control Group
Experimental Group Group D dexmedetomidine loading dose 1 ¿g/kg IV over 10 minute, before induction of anesthesia, followed by 0.4 ¿ 0.8 ¿g/kg/h IV infusion, during maintenance before induction of anesthesia, followed by IV infusion, during maintenance 18
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
¿ Adult patients, 20 to 45-year-old, of both genders, scheduled for elective FESS surgery. ¿ American society of anesthesiologists class (ASA) I and II patients. ¿ Patient refusal. ¿ ASA class III and IV. ¿ Any known hypersensitivity or contraindication to esmolol or dexmedetomidine. ¿ Patients with bleeding diathesis, respiratory problems, liver failure, kidney insufficiency or heart diseases (heart block, or myocardial ischemia). ¿ Patient with poorly controlled arterial hypertension (blood pressure higher than 140/90 mmHg). ¿ Patients planned for redo surgery for recurrent rhinosinusitis. ¿ Patients on anticoagulant, ¿2 agonist or ¿ blocker therapy. 20 Year(s) 45 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 10/12/2017 Ethics committee of anesthesia, intensive care and pain management department, Faculty of Medicine, Menoufia University
Ethics Committee Address
Street address City Postal code Country
Menoufia university hospitals, 25 Yassin Abdel Ghaffar St- from Gamal Abdel Anasar St Shben Elkom 002048 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome ¿ Total blood loss (ml) during the operation, which is collected by suction added to the estimated from nasal packing. at end of operation
Secondary Outcome ¿ Surgeon's satisfaction score with 4 points subjective scale (18) at the end of surgery, as follows:-. ¿ 1 = Bad. ¿ 2 = Moderate. ¿ 3 = Good. ¿ 4 = Excellent. at end of surgery
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Menoufia University Hospitals 25 Yassin Abdel Ghaffar St- from Gamal Abdel Anasar St Shebin el-kom 002048 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Faculty of Medicine, Menoufia University 25 Yassin Abdel Ghaffar St- from Gamal Abdel Anasar St Shebin el-kom 002048 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Faculty of Medicine, Menoufia University 25 Yassin Abdel Ghaffar St- from Gamal Abdel Anasar St Shebin el-kom 002048 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Eslam Ahmed Hassan Elsayed 25 Yassin Abdel Ghaffar St- from Gamal Abdel Anasar St Shebin el-kom 002048 Egypt
Prof. Khaled Mousa Abu Elenien 25 Yassin Abdel Ghaffar St- from Gamal Abdel Anasar St Shebin el-kom 002048 Egypt
Dr. Safaa Mohammed Helal 25 Yassin Abdel Ghaffar St- from Gamal Abdel Anasar St Shebin el-kom 002048 Egypt
Dr. Khaled Mohammed Gaballah 25 Yassin Abdel Ghaffar St- from Gamal Abdel Anasar St Shebin el-kom 002048 Egypt
Dr. Zeinab Abdel Aziz Kasemy 25 Yassin Abdel Ghaffar St- from Gamal Abdel Anasar St Shebin el-kom 002048 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Eslam Elsayed dr.eslamkayed1985@hotmail.com 00201157746146 25 Yassin Abdel Ghaffar St- from Gamal Abdel Anasar St
City Postal code Country Position/Affiliation
Shebin el-kom 002048 Egypt MBBCh, MSc Alexandria University
Role Name Email Phone Street address
Public Enquiries Khaled Gaballah khgaballah@gmail.com 00201016009073 25 Yassin Abdel Ghaffar St- from Gamal Abdel Anasar St
City Postal code Country Position/Affiliation
Shebin el-kom 002048 Egypt Lecturer of Anesthesia and Critical Care Faculty of Medicine, Menoufia University
Role Name Email Phone Street address
Scientific Enquiries Khaled Abu Elenien mahmoudk16@yahoo.com 00201015406676 25 Yassin Abdel Ghaffar St- from Gamal Abdel Anasar St
City Postal code Country Position/Affiliation
Shebin el-kom 002048 Egypt Professor of Anesthesia and Critical Care Faculty of Medicine, Menoufia University
REPORTING
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Changes to trial information