Mg Sulfate Versus Dexmedetomidine on Cerebral Oxygen Saturation

NCT ID: NCT06848595

Last Updated: 2025-02-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE3

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-02-23

Study Completion Date

2027-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This study is to evaluate the effects of dexmedetomidine and magnesium sulfate on cerebral oxygen saturation in patients undergoing spine surgeries as adjuvant to general anesthesia guided by cerebral oximetry. The main aims to are Incidence of cerebral desaturation events and duration of cerebral desaturation events.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cerebral Desaturation Events Spine Surgeries

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

MgSO4

loading dose of 40 mg/kg of magnesium sulfate diluted in 50 ml of 0.9% saline IVI will be given in 10 min before anesthesia induction then continuous infusion of 10 mg/kg/hour during the surgery.

Group Type ACTIVE_COMPARATOR

spine surgery

Intervention Type PROCEDURE

spine surgery in prone position

Magnesium sulfate

Intervention Type DRUG

Patients will receive loading dose of 40 mg/kg of magnesium sulfate diluted in 50 ml of 0.9% saline IVI will be given in 10 min before anesthesia induction then continuous infusion of 10 mg/kg/hour during the surgery.

dex.

Patients will receive loading dose of 1 mcg/kg dexmedetomidine diluted in 50 ml of saline 0.9% IVI will be given in 10 min before anesthesia induction then continuous infusion of 0.5 mcg/kg/hour during the surgery.

Group Type ACTIVE_COMPARATOR

spine surgery

Intervention Type PROCEDURE

spine surgery in prone position

Dexmedetomidine

Intervention Type DRUG

Patients will receive loading dose of 1 mcg/kg dexmedetomidine diluted in 50 ml of saline 0.9% IVI will be given in 10 min before anesthesia induction then continuous infusion of 0.5 mcg/kg/hour during the surgery.

control

Patients will receive the same volume of normal saline.

Group Type PLACEBO_COMPARATOR

spine surgery

Intervention Type PROCEDURE

spine surgery in prone position

Normal Saline (0.9% NaCl)

Intervention Type DRUG

Patients will receive the same volume of normal saline.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

spine surgery

spine surgery in prone position

Intervention Type PROCEDURE

Magnesium sulfate

Patients will receive loading dose of 40 mg/kg of magnesium sulfate diluted in 50 ml of 0.9% saline IVI will be given in 10 min before anesthesia induction then continuous infusion of 10 mg/kg/hour during the surgery.

Intervention Type DRUG

Dexmedetomidine

Patients will receive loading dose of 1 mcg/kg dexmedetomidine diluted in 50 ml of saline 0.9% IVI will be given in 10 min before anesthesia induction then continuous infusion of 0.5 mcg/kg/hour during the surgery.

Intervention Type DRUG

Normal Saline (0.9% NaCl)

Patients will receive the same volume of normal saline.

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Age from 21 to 60 years old.
* either gender.
* American Society of Anesthesiologists (ASA) physical status I and II.

Exclusion Criteria

* Patient refusal to participate in research.
* History of preoperative neuromuscular disease.
* Patients with preexisting cerebral pathology (such as previous episodes of cerebral ischemia or stroke).
* History of psychiatric illness.
* History of orthostatic hypotension, myocardial infarction, uncontrolled hypertension or documented carotid stenosis.
* Coagulopathy disorder.
* Patients receiving magnesium supplementation.
* Chronic use of opioids.
* Current treatment with a β-blocker or calcium channel blocker.
Minimum Eligible Age

21 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Tanta University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Ibrahim Elsayed

doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Ahmed Said Elgebaly, professor

Role: STUDY_DIRECTOR

Tanta University

Shimaa Farouk Abdelkader, professor

Role: STUDY_DIRECTOR

Tanta University

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Ibrahim Elsayed Elnefiawy, assisstant lectuerer

Role: CONTACT

00201001515007

Nadia Elsayed Elafify, assistant lectuerer

Role: CONTACT

0020110627640

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

36265MD317/11/24

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.