NCT06848595

Brief Summary

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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at below P25 for phase_3

Timeline
9mo left

Started Feb 2025

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress62%
Feb 2025Jan 2027

First Submitted

Initial submission to the registry

February 21, 2025

Completed
2 days until next milestone

Study Start

First participant enrolled

February 23, 2025

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 27, 2025

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 20, 2027

Expected
11 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2027

Last Updated

February 27, 2025

Status Verified

February 1, 2025

Enrollment Period

1.9 years

First QC Date

February 21, 2025

Last Update Submit

February 26, 2025

Conditions

Cerebral Desaturation EventsSpine Surgeries

Outcome Measures

Primary Outcomes (1)

  • Incidence of cerebral desaturation events.

    intraoperative

Secondary Outcomes (3)

  • Duration of cerebral desaturation events

    intraoperative

  • change in heart rate in beats

    intraoperative

  • change in blood pressure in mmHg

    Intraoperative

Study Arms (3)

MgSO4

ACTIVE COMPARATOR

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.

Procedure: spine surgeryDrug: Magnesium sulfate

dex.

ACTIVE COMPARATOR

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.

Procedure: spine surgeryDrug: Dexmedetomidine

control

PLACEBO COMPARATOR

Patients will receive the same volume of normal saline.

Procedure: spine surgeryDrug: Normal Saline (0.9% NaCl)

Interventions

spine surgeryPROCEDURE

spine surgery in prone position

MgSO4controldex.
Magnesium sulfateDRUG

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.

MgSO4
DexmedetomidineDRUG

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.

dex.
Normal Saline (0.9% NaCl)DRUG

Patients will receive the same volume of normal saline.

control

Eligibility Criteria

Age21 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Magnesium SulfateDexmedetomidineSaline Solution

Intervention Hierarchy (Ancestors)

Magnesium CompoundsInorganic ChemicalsSulfatesSulfuric AcidsSulfur AcidsSulfur CompoundsImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsCrystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Officials

  • Ahmed Said Elgebaly, professor

    Tanta University

    STUDY DIRECTOR

  • Shimaa Farouk Abdelkader, professor

    Tanta University

    STUDY DIRECTOR

Central Study Contacts

Ibrahim Elsayed Elnefiawy, assisstant lectuerer

CONTACT

00201001515007aborazan171@gmail.com

Nadia Elsayed Elafify, assistant lectuerer

CONTACT

0020110627640nadiaelsayed225@gmail.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
doctor

Study Record Dates

First Submitted

February 21, 2025

First Posted

February 27, 2025

Study Start

February 23, 2025

Primary Completion (Estimated)

January 20, 2027

Study Completion (Estimated)

January 31, 2027

Last Updated

February 27, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share