Trial no.:	PACTR201810909649406	Date of Approval:	15/10/2018
Trial Status:	Registered in accordance with WHO and ICMJE standards

TRIAL DESCRIPTION

Public title

Could intraoperative magnesium sulphate protect against postoperative cognitive dysfunction?

Official scientific title

Could intraoperative magnesium sulphate protect against postoperative cognitive impairment?

Brief summary describing the background and objectives of the trial

INTRODUCTION Postoperative cognitive dysfunction (POCD), distinct from postoperative delirium, is well described as a permanent decline of cognition after both cardiac and non-cardiac surgery [1, 2]. The incidence of POCD in old patients (>60 years) undergoing non-cardiac surgery is reported to be as high as 25.8 at 1 week and 9.9% at 3 months by the International Study of Postoperative Cognitive Dysfunction (ISPOCD) [3]. While another study conducted by Monk et al. found an incidence of 41.4% at discharge and 12.7% at 3 months in old patients with non-cardiac surgery [4]. POCD may prominently prolong the length of hospital stay, interfere the postoperative recovery [5], affect the quality of life [6] and increase the mortality [7]. Although POCD has been studied for several decades, the mechanisms of POCD still remain abstruse and a key issue about potential predicators for POCD requires being resolved. Previous studies have revealed that several factors (including postoperative pain, hypoperfusion, thrombosis, inflammatory status and anesthetic factors, etc.) might be involved in the mechanisms of POCD [8]. Potential predicative factors for POCD will be greatly helpful in the etiology investigation and risk evaluation after the surgery. Recent reports have revealed that S100B protein may be closely associated with POCD, however whether it can be used as a valid clinical indicator for POCD still remains unclear [9]. Investigations have indicated that overexpressed S100B can promote Aβ generation from amyloid precursor protein [10]. The increased Aβ and amyloid precursor protein is closely associated with cognition decline. This may provide a possible involved mechanism supporting the critical role of S100B in predicating POCD [11]. Magnesium sulfate has not been familiar to anesthesiologists until recently. However, magnesium plays a critical role in a variety of physiological processes of the human body. Recently,

Type of trial

RCT

Acronym (If the trial has an acronym then please provide)

Disease(s) or condition(s) being studied

Anaesthesia,Nervous System Diseases

Sub-Disease(s) or condition(s) being studied

Purpose of the trial

Prevention

Anticipated trial start date

13/10/2018

Actual trial start date

Anticipated date of last follow up

25/10/2018

Actual Last follow-up date

Anticipated target sample size (number of participants)

80

Actual target sample size (number of participants)

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
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously	Randomised	Simple randomization using a randomization table from a statistics book	Sealed opaque envelopes	Masking/blinding used	Participants

INTERVENTIONS
Intervention type	Intervention name	Dose	Duration	Intervention description	Group size	Nature of control
Experimental Group	Intraoperative magnesium sulphate	30 mg/kg magnesium sulphate as loading dose over 10 minutes then maintainance dose 10 mg/kg/hour	Intraoperative	Intraoperative magnesium sulphate 30 mg/kg magnesium sulphate as loading dose over 10 minutes then maintainance dose 10 mg/kg/hour	40
Control Group	intraoperative saline	30 mg/kg saline as loading dose over 10 minutes then maintainance dose 10 mg/kg/hour	intraoperative	30 mg/kg saline as loading dose over 10 minutes then maintainance dose 10 mg/kg/hour	40	Placebo

ELIGIBILITY CRITERIA
List inclusion criteria	List exclusion criteria	Age Category	Minimum age	Maximum age	Gender
1. Patients who are candidate for elective laparoscopic cholecystectomy 2. Patients should have the ability to read, write and do simple calculations 3. All the participants will be required to offer a written informed con¬sent	1. Patient subjected to gross hemodynamic or ventilatory fluctuations during the operation 2. Patient who developed postoperative shock or major bleeding 3. Patient with a history of neurodegenerative disease 4. Patients with concomitant medical or metabolic illness known to affect cognition 5. Patients with evidence of concomitant cerebrovascular stroke 6. Patient with a history of major head trauma 7. Patient with a history of epileptic fits in the last two years 8. Patient with a history of serious hearing or visual impairment 9. Patients with MRI brain showing structural lesion 10. Patients with a history of exposure to drug, toxic substances, alcohol, industrial agents, heavy metals, or any substance known to affect cognition.	Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s)	20 Year(s)	70 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

08/03/2018

Faculty of medicine. Beni suef university. Research ethical committee

Ethics Committee Address
Street address	City	Postal code	Country
Salah salem street	Beni suef	62511	Egypt

OUTCOMES
Type of outcome	Outcome	Timepoint(s) at which outcome measured
Primary Outcome	cognitive dysfunction	one week postoperative
Secondary Outcome	postoperative pain	one week postoperative

RECRUITMENT CENTRES
Name of recruitment centre	Street address	City	Postal code	Country
Beni suef university hospital	Salah Salem street	Beni suef	62511	Egypt

FUNDING SOURCES
Name of source	Street address	City	Postal code	Country
Self funded	Salah Salem street	Beni suef		Egypt

SPONSORS
Sponsor level	Name	Street address	City	Postal code	Country	Nature of sponsor
Secondary Sponsor	Beni suef university	Salah Salem street	Beni suef	62511	Egypt	University

COLLABORATORS
Name	Street address	City	Postal code	Country
Wael Fathy	Salah Salem street	Beni suef		Egypt
Tamer Nabil	Salah Salem street	Beni suef		Egypt

CONTACT PEOPLE
Role	Name	Email	Phone	Street address
Principal Investigator	Mona Hussein	mona.neuro@yahoo.com	01005131318	Salah Salem street
City	Postal code	Country	Position/Affiliation
Beni suef	62511	Egypt	Neurology lecturer
Role	Name	Email	Phone	Street address
Scientific Enquiries	Wael Fathy	drwaelfathy@yahoo.com	01006527133	Salah Salem street
City	Postal code	Country	Position/Affiliation
Beni suef	62511	Egypt	Anaesthesia lecturer
Role	Name	Email	Phone	Street address
Public Enquiries	Tamer Nabil	Tamernbl@hotmail.com	01063100888	Salah Salem street
City	Postal code	Country	Position/Affiliation
Beni suef	62511	Egypt	General surgery assistant professor

REPORTING
Share IPD	Description	Additional Document Types	Sharing Time Frame	Key Access Criteria
Undecided
URL	Results Available	Results Summary	Result Posting Date	First Journal Publication Date
	Yes	intraoperative magnesium sulphate has a protective effect against developing postoperative cognitive dysfunction and reduce the serum level of S100B; the marker of neuronal degeneration	12/10/2018	12/10/2018
Result Upload 1:	Result Upload 2:	Result Upload 3:	Result Upload 4:	Result Upload 5:

Result URL Hyperlinks	Link To Protocol
Result URL Hyperlinks	file:///C:/Users/Mona/Downloads/S100B,%20POCD%20and%20Magnesium%20sulphate.pdf

Changes to trial information

Pan African Clinical Trials Registry