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.: PACTR202102522324854 Date of Approval: 17/02/2021
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Comparison between metoprolol and pregabalin as premedication in spine surgery
Official scientific title Comparison between Metoprolol and Pregabalin as a Premedication for Controlled Hypotension in Spine Surgery
Brief summary describing the background and objectives of the trial This study is to compare between metoprolol and pregabalin as a premedication to induce controlled hypotensive anesthesia primarily controlontrol heart rate in spine surgery & to assess amount of blood loss, field visualization & side effects of both drugs
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: Other
Anticipated trial start date 08/08/2019
Actual trial start date 08/08/2019
Anticipated date of last follow up 16/02/2021
Actual Last follow-up date 20/07/2021
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 Sealed opaque envelopes Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Metoprolol group 50 mg tab 90 minutes before induction of anaesthesia Oral route 40
Control Group Pregabalin group 150 mg tab 90 minutes before induction of anaesthesia Oral route 40 Uncontrolled
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
ASA physical status I, aged from 18 to 50 years old scheduled for elective spine fixation surgeries will included In this study Any patient who has any of following will be excluded Hypertension, Diabetes mellitus, hepatic or renal disease, pregnancy, coagulation disorders, Anemia ( HB<10) , Ischaemia heart disease, drug or alcohol abuse, allergy to any of metoprolol or pregabalin, history of beta blockers, calcium channel blocker, tricyclic antidepressants, anticoagulant or clonidine intake Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 50 Year(s) Both
ASA physical status I, aged from 18 to 50 years old scheduled for elective spine fixation surgeries will included In this study Any patient who has any of following will be excluded Hypertension, Diabetes mellitus, hepatic or renal disease, pregnancy, coagulation disorders, Anemia ( HB<10) , Ischaemia heart disease, drug or alcohol abuse, allergy to any of metoprolol or pregabalin, history of beta blockers, calcium channel blocker, tricyclic antidepressants , anticoagulant or clonidine intake Adult: 19 Year-44 Year 18 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 19/12/2019 Menoufia faculty of medicine
Ethics Committee Address
Street address City Postal code Country
25 Yasin Abd-Elghafar Shebin Elkom 32511 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The primary aim of this study is to compare between metoprolol and pregabalin as premedication to induce controlled hypotensive anesthesia primarily control heart rate in spine surgery Each point vital parameter includes heart rate, mean systemic blood pressure, arterial oxygen saturation, will be recorded before induction every 15 minutes during operation, after recovery
Secondary Outcome The secondary aims is to assess field visualization and measure the amount of blood loss in patients of both groups, surgeons satisfaction and also to assess if there are any associated undesirable side effects of metoprolol or pregabalin wil appear Incidence of complications, bradycardia, or tachycardia, hypertension or hypotension, shivering, respiratory depression dizziness, visual disturbances, nausea, vomiting after 15 minutes of reco
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Menoufia university hospitals 25 Yasin Abd- Elghafar street Shebin Elkom 32511 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Menoufia university hospitals 25 Yasin Abd- Elghafar street Shebin Elkom 32511 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Menoufia university hospitals 25 Yasin Abd- Elghafar street Shebin Elkom 32511 Egypt Hospital
COLLABORATORS
Name Street address City Postal code Country
Mervat abd el moaty el maghraby 25 Yasin Abd- Elghafar street Shebin Elkom 32511 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Mervat abd El moaty El maghraby docmaive1992@gmail.com 0201096007502 25 Yasin Abd- Elghafar
City Postal code Country Position/Affiliation
Shebin Elkom 32511 Egypt Anaesthesia resident menoufia university hospitals
Role Name Email Phone Street address
Principal Investigator Nadia mohee ELdin Bahgat dr_nmbahgat@yahoo.com 0201009558238 Mohamed husseini street
City Postal code Country Position/Affiliation
Shebin Elkom 32511 Egypt Lecturer of anaesthesia and intensive care faculty of medicine menoufia university
Role Name Email Phone Street address
Scientific Enquiries Hatem Amin Atalla Hatattalla@hotmail.com 0201001445568 Al bahari street
City Postal code Country Position/Affiliation
Alexandria 21500 Egypt Professor of anaesthesia and intensive care. Faculty of medicine menoufia university
Role Name Email Phone Street address
Public Enquiries Osama El sharkawy docmaive92@gmail.com 0201223824088 25 Yasin Abd- Elghafar street
City Postal code Country Position/Affiliation
Shebin Elkom 32511 Egypt Professor of anaesthesia and intensive care faculty of medicine menoufia university
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes All individuals participant data collected during trial and after dedentification, demographic data , baseline and subsequent heart rate, blood pressure, saturation, fromm and Boezaar score, delayed recovery, hypertension, hypotension, bradycardia, respiratory depression, nausea, vomiting and post operative pain. Data will be available immediately after publication with any one who wish to access the data. Informed Consent Form,Statistical Analysis Plan,Study Protocol July 2021 Access controlled by Principal Investigator
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