Magnesium Sulfate for Prevention of Emergence Agitation in Lumbar Disc Surgery

NCT07139847 | Not Yet Recruiting

• 1 other identifier: GUAH-MAG-2025-01
• Study Type: interventional
• Target: 70
• Locations: 0 countries
• Sites: N/A

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. The primary outcome is the incidence of emergence agitation in the post-anesthesia care unit (PACU), assessed at admission and at 5, 10, 15, and 30 minutes using the Ramsay Sedation Scale. Secondary outcomes include postoperative pain scores (Numeric Rating Scale), intraoperative remifentanil consumption, recovery and extubation times, tramadol use in the PACU, and any adverse events related to magnesium infusion.

Conditions

Lumbar Disc Herniation; Emergence Agitation; Magnesium Sulfate

Keywords

Magnesium Sulfate; Lumbar Disc Herniation; Postoperative Complications

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Postoperative Pain Scores in PACU

  At PACU admission (T0) and at 5, 10, 15, and 30 minutes post-admission.

Study Arms (2)

Magnesium Sulfate Infusion

ACTIVE COMPARATOR

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.

Drug: Magnesium Sulfate Infusion

0.9% Saline Infusion

PLACEBO COMPARATOR

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

Drug: 0.9% Saline Infusion

Interventions

Magnesium Sulfate Infusion DRUG

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 blinding of participants, anesthesia providers, and outcome assessors.

Magnesium Sulfate Infusion

0.9% Saline Infusion DRUG

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.

0.9% Saline Infusion

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ondokuz Mayıs University: lead

Related Publications (3)

• 1. McKeown, A., & Agarwala, R. (2020). "Emergence agitation: Recognition, prevention, and treatment." BJA Education, 20(6), 180-184. https://doi.org/10.1016/j.bjae.2020.03.002

  RESULT

• Yu D, Chai W, Sun X, Yao L. Emergence agitation in adults: risk factors in 2,000 patients. Can J Anaesth. 2010 Sep;57(9):843-8. doi: 10.1007/s12630-010-9338-9. Epub 2010 Jun 5.

  PMID: 20526708 RESULT

• Soltész, P., Silvasti, M., & Taivainen, T. (2013). "Emergence agitation in adults after general anesthesia: A comparison of sevoflurane and propofol." Acta Anaesthesiologica Scandinavica, 57(3), 315-321. https://doi.org/10.1111/aas.12047

  RESULT

MeSH Terms

Conditions

Intervertebral Disc Displacement; Emergence Delirium; Postoperative Complications

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Pathologic Processes; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Central Study Contacts

İlke tamdoğan, MD

CONTACT

+905062916678; drilkeipek@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Both participants and clinical staff (including anesthesia providers) were blinded to group allocation. Group assignments were determined using sealed opaque envelopes and were only known to an anesthesia technician not involved in patient care or outcome assessment. The infusion solutions (magnesium sulfate or 0.9% saline) were prepared in identical syringes to maintain blinding.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D.

Model Details: Participants will be randomly assigned in a 1:1 ratio to one of two parallel groups: the experimental group receiving intraoperative magnesium sulfate infusion and the control group receiving an equivalent volume of 0.9% saline. Both groups will be managed under a standardized general anesthesia protocol, and outcomes will be assessed in the post-anesthesia care unit (PACU) by blinded evaluators.

Study Record Dates

• First Submitted: August 15, 2025
• First Posted: August 24, 2025
• Study Start: December 30, 2025
• Primary Completion (Estimated): July 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: December 12, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share