Magnesium Sulfate for Prevention of Emergence Agitation in Lumbar Disc Surgery

NCT07139847 | Not Yet Recruiting

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

Brief Summary

In this retrospective study, the effect of intraoperative magnesium sulfate infusion on the incidence of postoperative emergence agitation was evaluated in adult patients who underwent elective lumbar microdiscectomy under general anesthesia. The medical records of patients aged 18-70 years with an ASA physical status of I-II were retrospectively reviewed. Patients were evaluated according to whether they received intraoperative magnesium sulfate infusion as part of anesthetic management. The primary outcome measure was the incidence of emergence agitation in the post-anesthesia care unit; this assessment was based on Ramsay Sedation Scale scores recorded in the post-anesthesia care unit at admission and at 5, 10, 15, and 30 minutes. Secondary outcome measures included postoperative pain scores assessed using the Numeric Rating Scale, intraoperative remifentanil consumption, recovery and extubation times, tramadol requirement in the post-anesthesia care unit, and possible 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

Patients who underwent elective single-level lumbar microdiscectomy under general anesthesia and received intraoperative magnesium sulfate infusion as part of anesthetic management were included in this group. Magnesium sulfate was administered as a 30 mg/kg intravenous bolus over 15 minutes after induction, followed by a continuous infusion at 10 mg/kg/h until the end of surgery.Intraoperative magnesium sulfate infusion was retrospectively evaluated. Magnesium sulfate had been administered as part of routine anesthetic management and was not an intervention assigned by the investigators for the purpose of this retrospective study.

Drug: Magnesium Sulfate Infusion

0.9% Saline Infusion

Patients who underwent elective single-level lumbar microdiscectomy under general anesthesia and did not receive intraoperative magnesium sulfate infusion were included in this group. These patients were managed with the standard anesthesia protocol.Patients in this group had not received intraoperative magnesium sulfate infusion. Standard anesthetic management was retrospectively evaluated from medical records and was not an intervention assigned by the investigators for the purpose of this retrospective study.

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+)
• Sampling Method: Probability Sample

Study Population

Adult patients aged 18-70 years with an ASA physical status of I or II who underwent elective single-level lumbar microdiscectomy under general anesthesia at Giresun Training and Research Hospital were included in the study population. The study population consisted of patients whose medical records contained complete perioperative and post-anesthesia care unit data required for the retrospective evaluation of intraoperative magnesium sulfate infusion and postoperative emergence agitation.

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: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 1 Month
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D.

Study Record Dates

• First Submitted: August 15, 2025
• First Posted: August 24, 2025
• Study Start: July 5, 2026
• Primary Completion (Estimated): August 30, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: June 25, 2026

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share