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.: PACTR202006485196275 Date of Approval: 24/06/2020
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title effect of magnesium sulphate and dexmedetomidine on cerebral oxygenation in shoulder surgery
Official scientific title Cerebral oxygenation during hypotensive anesthesia in shoulder arthroscopy: comparative study between magnesium sulphate and dexmedetomidine
Brief summary describing the background and objectives of the trial there has been recent concern that beach chair positioning may be an independent risk factor for intraoperative cerebrovascular insult, especially in concert with hypotensive anesthesia Magnesium sulphate was previously used to induce deliberate hypotension. It produces its hypotensive effect by limiting the outflow of calcium from the sarcoplasmic reticulum and produces a vasodilating effect by increasing the synthesis of prostacyclin and inhibiting angiotensin converting enzyme activity. Hypotension induced by magnesium during surgery is also explained by its powerful analgesic effect . The analgesic action of magnesium is explained by its antagonistic effect at N-methyl d-aspartate receptors Dexmedetomidine is an α-2 adrenoreceptor agonist. It decreases heart rate and arterial blood pressure by reducing norepinephrine and epinephrine plasma levels . Activation of postsynaptic receptors in the central nervous system by α2-agonists inhibits the sympathetic activity and decreases heart rate and blood pressure and causes sedation The aim of our study is to evaluate the effects of the induced hypotension during beach-chair position on regional cerebral oxygen saturation (rSO2) in patients undergoing arthroscopic shoulder surgery by using near-infrared spectroscopy We compare the safety and efficacy of magnesium sulphate and dexmedetomidine in deliberate hypotensive anesthesia for patients undergoing shoulder arthroscope.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Anaesthesia,Orthopaedics
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 15/06/2020
Actual trial start date
Anticipated date of last follow up 15/12/2020
Actual Last follow-up date
Anticipated target sample size (number of participants) 100
Actual target sample size (number of participants)
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
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 Care giver/Provider,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group magnesium sulphate magnesium sulphate 40 mg/kg intravenous bolus over 10 minutes then 15mg/kg/h intravenous continuous infusion bolus dose will be given before induction of anesthesia then continuous infusion will be during the operation we will give magnesium sulphate 40 mg/kg intravenous bolus over 10 minutes before induction then 15mg/kg/h intravenous continuous infusion during the operation 50 Uncontrolled
Experimental Group dexmedetomidine dexmedetomidine 1 µg/kg intravenous bolus over 10 minutes then 0.5 µg/kg/h intravenous continuous infusion dexmedetomidine bolus dose over 10 minutes before induction then intravenous continuous infusion during the operation. we will give dexmedetomidine 1 µg/kg intravenous bolus over 10 minutes before induction then 0.5 µg/kg/h intravenous continuous infusion during the operation. 50
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
patients aged 20-60 years, both sex, elective arthroscopic shoulder surgery in the beach chair position will be enrolled in the study patient's refusal, pre-existing cerebrovascular or psychiatric disorders, carotid stenosis, cervical stenosis or cervical disc herniation, myocardial infarction, spinal cord injury, a history of stroke, transient ischemic attack, orthostatic hypotension or syncope, or neck surgery. Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 20 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 31/05/2020 Research Ethics Committee Tanta Univ
Ethics Committee Address
Street address City Postal code Country
Elgeish St Tanta 31527 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome frequency of cerebral oxygen desaturation. intraoperative during the whole time of surgery from the start of infusion of the study drugs until discontinue the infusion of the drugs
Secondary Outcome Cognitive dysfunction is evaluated by mini mental state examination (MMSE). The test will be performed the night before operation then before discharge and at day 3 of surgery when the patients come to the hospital for physiotherapy
Secondary Outcome haemodynamic parameters which is heart rate and mean arterial blood pressure Baseline HR and MBP will be recorded as base line, after end of bolus dose of hypotensive drug, immediately after intubation, immediately after beach chair positioning, then every 10 min until the
Secondary Outcome surgeon satisfaction postoperative
Secondary Outcome Complications (e.g. nausea, vomiting, hypotension when MBP <65 mmHg, bradycardia when HR<50 beat/min). intraoperative and up to 24 hours postoperative
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Tanta University Facualty of Medicine Elgeish street Tanta 31527 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Mona Raafat Elghamry Elgeish St Tanta 31527 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Mona Raafat Elghamry Elgeish St Tanta 31527 Egypt Individual
COLLABORATORS
Name Street address City Postal code Country
Mohammad Ali Abduallah Elgeish St Tanta 31527 Egypt
Mona Raafat Elghamry Elgeish St Tanta 31527 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Mohammad Abduallah Moh_aly_2005@hotmail.com +201099957971 Elgeish St
City Postal code Country Position/Affiliation
Tanta 31527 Egypt Assistant professor
Role Name Email Phone Street address
Scientific Enquiries Mohammad Abduallah Moh_aly_2005@hotmail.com +201099957971 Elgeish St
City Postal code Country Position/Affiliation
Tanta 31527 Egypt Assistant professor
Role Name Email Phone Street address
Public Enquiries Mona Elghamry drmonagh19802000@gmail.com +201060101867 Elgeish St
City Postal code Country Position/Affiliation
Tanta 31527 Egypt lecturer
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes statistics of age ,sex,BMI, duration of surgery frequency of cerebral oxygen desaturation, cognitive dysfunction, surgeon satisfaction, and adverse effects Statistical Analysis Plan IPD will be shared after finishing and publication of the study and it will be available for 6 months the IPD will be available for scientific research only up on e-mail request. request will be sent to e-mail of one of the authors (drmonagh19802000@gmail.com)
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