Trial no.:	PACTR202408593043200	Date of Registration:	21/08/2024
Trial Status:	Registered in accordance with WHO and ICMJE standards

TRIAL DESCRIPTION

Public title

Effect of Dexmedetomidine (Precedex) Administration during Awake Craniotomy on Postoperative Inflammatory Markers and Stress Hormones

Official scientific title

Effect of Dexmedetomidine (Precedex) Administration during Awake Craniotomy on Postoperative Inflammatory Markers and Stress Hormones in Patients with Chronic Subdural Hemorrhage: A Randomized controlled Study

Brief summary describing the background and objectives of the trial

Chronic subdural hemorrhage (CSDH) is a prevalent neurological condition, particularly among the elderly, characterized by the accumulation of blood between the dura mater and the arachnoid layer of the brain. It can result from minor head trauma, often presenting with symptoms such as headaches, cognitive impairment, and motor deficits The management of CSDH typically involves surgical intervention, with craniotomy being one of the common procedures employed Awake craniotomy has gained attention for its potential benefits in neurosurgical procedures, including improved intraoperative patient monitoring and the ability to perform functional mapping of the brain Recent studies have highlighted the role of inflammatory markers and stress hormones as indicators of surgical stress and predictors of postoperative outcomes. Elevated levels of markers such as interleukins (IL-6, IL-8) and stress hormones such as noradrenaline have been associated with adverse postoperative outcomes, including prolonged recovery and increased complication rates The aim of this study is to detect role of the administration of dexmedetomidine during awake craniotomy on the inflammatory and stress response, potentially improving postoperative recovery

Type of trial

RCT

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

Disease(s) or condition(s) being studied

Nervous System Diseases

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

Purpose of the trial

Treatment: Drugs

Anticipated trial start date

10/09/2024

Actual trial start date

15/09/2024

Anticipated date of last follow up

15/01/2025

Actual Last follow-up date

31/12/2024

Anticipated target sample size (number of participants)

62

Actual target sample size (number of participants)

Recruitment status

Active, not 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	Participants

INTERVENTIONS
Intervention type	Intervention name	Dose	Duration	Intervention description	Group size	Nature of control
Control Group	General Anesthesia	Patients will receive standard general anesthesia with agents such as propofol, fentanyl, and sevoflurane.	intraoperative	• Patients will receive standard general anesthesia with agents such as propofol, fentanyl, and sevoflurane. • Standard monitoring and supportive care will be provided throughout the procedure	31	Placebo
Experimental Group	Awake Craniotomy with Dexmedetomidine	Patients will receive a loading dose of dexmedetomidine at 1 μg/kg over 10 minutes, followed by a continuous infusion of 0.2-0.7 μg/kg/hr during the surgery.	intraoperative	Patients will receive a loading dose of dexmedetomidine at 1 μg/kg over 10 minutes, followed by a continuous infusion of 0.2-0.7 μg/kg/hr during the surgery. • Sedation levels will be monitored and adjusted to maintain patient comfort while allowing for neurological assessment.	31

ELIGIBILITY CRITERIA
List inclusion criteria	List exclusion criteria	Age Category	Minimum age	Maximum age	Gender
Patients aged 18-80 years. Diagnosed with chronic subdural hemorrhage. Scheduled for elective craniotomy. Able to provide informed consent	• Patients with a history of previous brain surgery. • Presence of other significant neurological disorders. • Severe comorbidities (e.g., uncontrolled diabetes, severe cardiac disease). • Allergies or contraindications to dexmedetomidine or anesthetic agents. • Patients requiring emergency surgery.	80 and over: 80+ Year,Adult: 18 Year(s)-44 Year(s),Aged: 65 Year(s)-79 Year(s),Middle Aged: 45 Year(s)-64 Year(s)	18 Year(s)	80 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

13/08/2024

mansoura university faculty of medicine MFM IRB

Ethics Committee Address
Street address	City	Postal code	Country
El gomhuria street mansoura university	mansoura	7650001	Egypt

OUTCOMES
Type of outcome	Outcome	Timepoint(s) at which outcome measured
Primary Outcome	Levels of inflammatory markers (C-reactive protein [CRP], interleukin-6 [IL-6], interleukin-8 [IL-8]) measured preoperatively, immediately postoperatively, and at 24 and 48 hours postoperatively	immediately postoperatively, and at 24 and 48 hours postoperatively
Secondary Outcome	Levels of stress hormones (cortisol, noradrenaline) measured preoperatively, immediately postoperatively, and at 24 and 48 hours postoperatively Postoperative pain levels assessed using the Visual Analog Scale (VAS) at 24 and 48 hours postoperatively. Time to discharge from the hospital. Incidence of postoperative complications (e.g., infection, hematoma recurrence). Time to first rescue analgesic request Mean arterial pressure at 0,2,4.8,16and 24 hours postoperatively Heart rate at 0,2,4,8,16 and 24 hours postoperatively	immediately postoperatively, and at 24 and 48 hours postoperatively

RECRUITMENT CENTRES
Name of recruitment centre	Street address	City	Postal code	Country
faculty of medicine mansoura university	el gomhuria street	mansoura	7650001	Egypt

FUNDING SOURCES
Name of source	Street address	City	Postal code	Country
faculty of medicine mansoura university	el gomhuria street	mansoura	7650001	Egypt

SPONSORS
Sponsor level	Name	Street address	City	Postal code	Country	Nature of sponsor
Secondary Sponsor	faculty of medicine mansoura university	el gomhuria street	mansoura	7650001	Egypt	University

COLLABORATORS
Name	Street address	City	Postal code	Country

CONTACT PEOPLE
Role	Name	Email	Phone	Street address
Principal Investigator	mohamed salama	mohamed_615@yahoo.com	00201069940993	gehan street
City	Postal code	Country	Position/Affiliation
mansoura university	7650001	Egypt	lecturer of anesthesia and surgical icu
Role	Name	Email	Phone	Street address
Scientific Enquiries	ahmed abdelwahab	ahmedmohamed95@mans.edu.eg	00201023425946	elgomhuria
City	Postal code	Country	Position/Affiliation
mansoura	7650001	Egypt	assistant lecturer of neurosurgery
Role	Name	Email	Phone	Street address
Public Enquiries	Hossam Eldin Abdel Twab	hosamtwab@mans.edu.eg	00201111575606	elgomhuria street
City	Postal code	Country	Position/Affiliation
mansoura	7650001	Egypt	assistant professor of clinical pathology

REPORTING
Share IPD	Description	Additional Document Types	Sharing Time Frame	Key Access Criteria
Yes	De -identified individual participant data for all primary and secondary outcome measures will be made available	Analytic Code,Clinical Study Report,Informed Consent Form,Statistical Analysis Plan	will be available within 6 months of study completion	Data access requests will be reviewed by an external independent review panel .requestors will be required to sign a data access agreement
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

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