Magnesium Sulfate for Prevention of Emergence Agitation in Lumbar Disc Surgery

NCT ID: NCT07139847

Last Updated: 2025-12-12

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-12-30
• Study Completion Date: 2026-12-30

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.

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 consent, adult patients aged 18-70 years, classified as ASA physical status I or II, scheduled for single-level lumbar microdiscectomy, will be enrolled. Exclusion criteria include severe cardiovascular disease, psychiatric disorders, neuromuscular disease, pregnancy, hepatic or renal dysfunction, use of calcium channel blockers, hypnotics, anxiolytics, antipsychotics, allergy to study drugs, or refusal to participate.

Participants will be randomized (1:1) using a computer-generated sequence to either:

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

Control Group (Group K): Equivalent volume and rate of 0.9% saline.

All patients will receive standardized anesthesia, including premedication with midazolam, induction with propofol, fentanyl, and rocuronium, and maintenance with sevoflurane in 50% air/oxygen mixture. Remifentanil infusion (0.1-0.25 µg/kg/min) will be adjusted to maintain target bispectral index (BIS) values between 40 and 60.

The primary outcome is the incidence of emergence agitation in the post-anesthesia care unit (PACU), measured at admission (T0) and at 5 (T1), 10 (T2), 15 (T3), and 30 (T4) minutes post-admission using the Ramsay Sedation Scale (RSS).

Secondary outcomes include Numeric Rating Scale (NRS) pain scores at the same PACU time points, total intraoperative remifentanil consumption, recovery time (from sevoflurane discontinuation to eye opening), extubation time (from sevoflurane discontinuation to extubation), meperidine use in the PACU, and the incidence of adverse events (arrhythmia, neuromuscular blockade, respiratory difficulties) related to magnesium infusion.

Sample size was calculated based on pilot data, requiring 32 participants per group for 80% power at a 0.05 significance level, with 35 enrolled per group to account for potential dropouts. Statistical analysis will use Student's t-test or Mann-Whitney U test for continuous variables, Chi-square or Fisher's exact test for categorical variables, with significance set at p < 0.05. Analyses will be performed using SPSS v25.0.

Conditions

Lumbar Disc Herniation; Emergence Agitation; Magnesium Sulfate

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: TRIPLE

Study Groups

Magnesium 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.

Group Type: ACTIVE_COMPARATOR

Magnesium Sulfate Infusion

Intervention Type: 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.

0.9% 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

Group Type: PLACEBO_COMPARATOR

0.9% Saline Infusion

Intervention Type: 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.

Interventions

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.

Intervention Type: DRUG

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.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ondokuz Mayıs University

OTHER

Sponsor Role: lead

Responsible Party

Ilke Tamdogan

M.D.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

İlke tamdoğan, MD

Role: CONTACT

drilkeipek@gmail.com

+905062916678

References

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

Reference Type: 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.

Reference Type: RESULT

PMID: 20526708 (View on PubMed)

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

Reference Type: RESULT

Other Identifiers

GUAH-MAG-2025-01

Identifier Type: -

Identifier Source: org_study_id