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NCT Number: NCT06848595

Mg Sulfate Versus Dexmedetomidine on Cerebral Oxygen Saturation

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.

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Key information

Age range

21 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Spine surgery

Procedure

spine surgery in prone position

Magnesium sulfate

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.

Dexmedetomidine

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.

Normal Saline (0.9% NaCl)

Drug

Patients will receive the same volume of normal saline.

Primary outcomes

  1. Incidence of cerebral desaturation events.

    Time frame: intraoperative

Secondary outcomes

  1. Duration of cerebral desaturation events

    Time frame: intraoperative

  2. change in heart rate in beats

    Time frame: intraoperative

  3. change in blood pressure in mmHg

    Time frame: Intraoperative

Study contacts

Contact information is provided by the study sponsor or research team.

Ibrahim Elsayed Elnefiawy, assisstant lectuerer

CONTACT

[email protected]

00201001515007

Nadia Elsayed Elafify, assistant lectuerer

CONTACT

[email protected]

0020110627640

Sponsors and collaborators

Lead sponsor

Tanta University

Other

Registry information

Official study title

Effects of Dexmedetomidine Versus Magnesium Sulfate on Cerebral Oxygen Saturation During Spine Surgery: a Prospective Randomized Controlled Study

Acronym: mg/dex/rSO2

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Feb 27, 2025
Registry last updated
Feb 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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