Magnesium Sulfate for Prevention of Emergence Agitation in Lumbar Disc Surgery

Официальное название

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

Обзор

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.

Подробное описание

This retrospective study was conducted at Giresun Training and Research Hospital. The aim of the study was to evaluate the effect of intraoperative magnesium sulfate infusion on postoperative emergence agitation in patients undergoing elective lumbar microdiscectomy under general anesthesia.

After institutional ethics committee approval was obtained, the medical records of adult patients aged 18-70 years, classified as ASA physical status I or II, who underwent single-level elective lumbar microdiscectomy under general anesthesia were retrospectively reviewed.

Patients were evaluated in two groups according to intraoperative anesthetic management:

Magnesium Group (Group M): Patients who received a 30 mg/kg intravenous bolus of magnesium sulfate over 15 minutes after induction, followed by a continuous magnesium sulfate infusion at a dose of 10 mg/kg/h until the end of surgery.

Control Group (Group K): Patients who did not receive magnesium sulfate infusion and were managed with a standard anesthesia protocol.

The primary outcome measure was the incidence of emergence agitation in the post-anesthesia care unit (PACU). Emergence agitation was retrospectively assessed from PACU records using the Ramsay Sedation Scale (RSS) at admission to the PACU (T0) and at 5 (T1), 10 (T2), 15 (T3), and 30 (T4) minutes after admission.

Secondary outcome measures included Numeric Rating Scale (NRS) pain scores recorded at the same PACU time points, total intraoperative remifentanil consumption, recovery time defined as the time from discontinuation of sevoflurane to eye opening, extubation time defined as the time from discontinuation of sevoflurane to extubation, meperidine requirement in the PACU, and possible adverse events related to magnesium infusion. These adverse events included arrhythmia, prolonged neuromuscular blockade, and respiratory difficulty.

Вмешательства

• Препарат 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 blinding of participants, anesthesia providers, and outcome assessors.
• Препарат 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.

Первичные конечные точки

• Incidence of Emergence Agitation in the PACU [Срок оценки: At PACU admission (T0) and at 5, 10, 15, and 30 minutes post-admission.]

Вторичные конечные точки (1)

• Postoperative Pain Scores in PACU [Срок оценки: At PACU admission (T0) and at 5, 10, 15, and 30 minutes post-admission.]

Критерии участия

Критерии включения

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

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Публикации

• 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
• 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
• 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

Идентификаторы

NCT: NCT07139847 · GUAH-MAG-2025-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗