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Clinical Trial NCT07139847 for Lumbar Disc Herniation, Emergence Agitation, Magnesium Sulfate is not yet recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
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Magnesium Sulfate for Prevention of Emergence Agitation in Lumbar Disc Surgery 70 Randomized Double-Blind Prevention

Not yet recruiting
Clinical Trial NCT07139847 is an interventional study for Lumbar Disc Herniation, Emergence Agitation, Magnesium Sulfate and is currently not yet recruiting. Enrollment is planned to begin on 30 December 2025 and continue until the study accrues 70 participants. Led by Ondokuz Mayıs University, this study is expected to complete by 30 December 2026. The latest data from ClinicalTrials.gov was last updated on 12 December 2025.
Brief Summary
This randomized, double-blind, controlled trial investigates the effect of intraoperative magnesium sulfate infusion on the incidence of postoperative emergence agitation in adult patients undergoing elective lumbar microdiscectomy under general anesthesia. Eligible participants (ASA physical status I-II, aged 18-70 years) will be randomly assigned to receive either magnesium sulfate or 0.9% saline during surgery. Th...Show More
Detailed Description
This prospective, randomized, double-blind, controlled trial will be conducted at Ondokuz Mayis University and Giresun Training and Research Hospital. The study aims to evaluate the effect of intraoperative magnesium sulfate infusion on postoperative emergence agitation (EA) in patients undergoing elective lumbar microdiscectomy under general anesthesia.

Following ethics committee approval and written informed conse...

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Official Title

Effect of Intraoperative Magnesium Infusion on Postoperative Emergence Agitation in Patients Undergoing Lumbar Microdiscectomy

Conditions
Lumbar Disc HerniationEmergence AgitationMagnesium Sulfate
Publications
Scientific articles and research papers published about this clinical trial:
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Other Study IDs
  • GUAH-MAG-2025-01
NCT ID Number
NCT07139847
Start Date (Actual)
2025-12-30
Last Update Posted
2025-12-12
Completion Date (Estimated)
2026-12-30
Enrollment (Estimated)
70
Study Type
Interventional
PHASE
N/A
Status
Not yet recruiting
Keywords
Magnesium Sulfate
Lumbar Disc Herniation
Postoperative Complications
Primary Purpose
Supportive Care
Design Allocation
Randomized
Interventional Model
Parallel
Masking
Triple
Arms / Interventions
Participant Group/ArmIntervention/Treatment
Active ComparatorMagnesium Sulfate Infusion
Participants assigned to this group will receive an intravenous bolus of magnesium sulfate 30 mg/kg over 15 minutes immediately after induction of general anesthesia, followed by continuous infusion at 10 mg/kg/h until the end of surgery.
Magnesium Sulfate Infusion
Magnesium Sulfate (Experimental Group) Intravenous bolus of magnesium sulfate 30 mg/kg administered over 15 minutes immediately after induction of general anesthesia, followed by continuous infusion at 10 mg/kg/h until the end of surgery. Solutions were prepared in identical syringes and infusion bags by an anesthesia technician not involved in patient care. The preparation and administration protocol ensured blindin...Show More
Placebo Comparator0.9% Saline Infusion
Participants assigned to this group will receive an intravenous bolus and continuous infusion of 0.9% sodium chloride solution in the same volume, infusion rate, and duration as the magnesium sulfate group
0.9% Saline Infusion
ntravenous bolus and continuous infusion of 0.9% sodium chloride solution in the same volume, infusion rate, and duration as the magnesium sulfate group. Solutions were indistinguishable in appearance and prepared under the same blinding procedures.
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Incidence of Emergence Agitation in the PACU
Percentage of participants with a Ramsay Sedation Scale (RSS) score ≥5, indicating emergence agitation, in the post-anesthesia care unit (PACU)
At PACU admission (T0) and at 5, 10, 15, and 30 minutes post-admission.
Secondary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Postoperative Pain Scores in PACU
Numeric Rating Scale (NRS) pain scores ranging from 0 (no pain) to 10 (worst pain).
At PACU admission (T0) and at 5, 10, 15, and 30 minutes post-admission.
Participation Assistant
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All

Age between 18 and 70 years

ASA physical status classification I or II

Scheduled for elective single-level lumbar microdiscectomy under general anesthesia

Ability to provide written informed consent

Severe cardiovascular disease

History of psychiatric disorder

Neuromuscular disease

Pregnancy or breastfeeding

Hepatic or renal dysfunction

Current use of calcium channel blockers, hypnotics, anxiolytics, or antipsychotic medications

Known allergy to magnesium sulfate or study-related medications

Refusal to participate in the study

Ondokuz Mayıs University logoOndokuz Mayıs University
Study Responsible Party
Ilke Tamdogan, Principal Investigator, M.D., Ondokuz Mayıs University
Study Central Contact
Contact: İlke tamdoğan, MD, +905062916678, [email protected]
No location data.