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.: PACTR201902822178026 Date of Approval: 18/02/2019
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title A randomized controlled double-blind study comparing dexmedetomidine and esmolol effects on Cardiac recovery in patients undergoing valve replacement surgery.
Official scientific title A randomized controlled double-blind study comparing dexmedetomidine and esmolol effects on Cardiac recovery in patients undergoing valve replacement surgery.
Brief summary describing the background and objectives of the trial Myocardial protection for open heart surgery is of great importance in preventing perioperative morbidity and mortality and may have a long-term impact on the preservation of postoperative myocardial function. It is widely proved that increased sympathetic nervous system activity plays a fundamental role in the development of perioperative cardiac complications, and that pharmacological attenuation of this response leads to improved patient outcomes. The study aimed to evaluate and compare the effects of dexmedetomidine and esmolol on cardiac recovery and ventricular rhythm during cardiopulmonary bypass in valve replacement surgeries.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Anaesthesia,Cardiology,Circulatory System
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 01/01/2017
Actual trial start date 02/01/2017
Anticipated date of last follow up 01/01/2019
Actual Last follow-up date 01/01/2019
Anticipated target sample size (number of participants) 120
Actual target sample size (number of participants) 105
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
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
Control Group dexmedetomidine loading dose 0.05 ug/kg over 10 min with induction of anesthesia then reduced to the 0.05 ug/kg/h until closure of incision loading dose over 10 min with induction of anesthesia then maintainance dose until closure of incision iv administration 35 Uncontrolled
Experimental Group esmolol bolus of 0.5 mg/kg/min over 10 min. then 0.05mg/kg/min until closure of incision a bolus of over 10 min. then maitainance dose until closure of incision iv adminstration 35
Control Group normal saline a bolus of 0.5 mg/kg/min over 10 min. then 0.05mg/kg/min until closure of incision a bolus of 0.5 mg/kg/min over 10 min. then 0.05mg/kg/min until closure of incision iv administration 35 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
patients aged 18-70 years old, ASA I-III, of both sexes undergoing valve replacement surgery Patients refused to take part in the study, allergic to esmolol and dexmedetomidine, asthmatic, history of β-blocker or dexmedetomidine intake, history of cardiac conduction abnormalities and with pericarditis Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 60 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 25/12/2016 local ethics and research comittee of anesthesia department faculty of medicine menoufia university
Ethics Committee Address
Street address City Postal code Country
3, yassin abdelghafar street shibin elkoom 1234 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome the recovery time (time from reperfusion to steady heart rate) intraoperative from reperfusion to steady heart rate
Secondary Outcome ventricular fibrillation intraoperative
Secondary Outcome atrial fibrillation intraoperative
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
menoufia university hospital 3, yassin abdelghafar street shibin elkoom 1234 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
menoufia university hospital 3, yassin abdelghafar street shibin elkoom 1234 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor menoufia university hospitals 3, yassin abdelghafar street shibin elkoom 1234 Egypt Hospital
COLLABORATORS
Name Street address City Postal code Country
ahmed abdelraouf metwally 3, yassin abdelghafar street shibin elkoom 1234 Egypt
asmaa hamza 3, yassin abdelghafar street shibin elkoom 1234 Egypt
khalled gaballah 3, yassin abdelghafar street shibin elkoom 1234 Egypt
sadik abdelmaseeh 3, yassin abdelghafar street shibin elkoom 1234 Egypt
mohammed elhagaly 3, yassin abdelghafar street shibin elkoom 1234 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator ashraf eskandr ameskandr@yahoo.com 00201001960697 3, yassin abdelghafar street
City Postal code Country Position/Affiliation
shibin elkoom 1234 Egypt associate professor of anesthesia
Role Name Email Phone Street address
Public Enquiries ahmed metwally drahmedabdelraoufmetwally@yahoo.com 00201227968325 3, yassin abdelghafar street
City Postal code Country Position/Affiliation
shibin elkoom 1234 Egypt professor of anesthesia
Role Name Email Phone Street address
Scientific Enquiries ashraf eskandr ameskandr@yahoo.com 00201001960697 3, yassin abdelghafar street
City Postal code Country Position/Affiliation
shibin elkoom Egypt associate professor of anesthesia
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
No
URL Results Available Results Summary Result Posting Date First Journal Publication Date
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