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Magnesium Sulfate for Prevention of Emergence Agitation in Lumbar Disc Surgery

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

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07139847
Enrollment
70
Registered
2025-08-24
Start date
2025-12-30
Completion date
2026-12-30
Last updated
2025-12-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lumbar Disc Herniation, Emergence Agitation, Magnesium Sulfate

Keywords

Magnesium Sulfate, Lumbar Disc Herniation, Postoperative Complications

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.

Interventions

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.

DRUG0.9% 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.

Sponsors

Ondokuz Mayıs University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)

Masking description

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.

Intervention model description

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.

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Incidence of Emergence Agitation in the PACUAt PACU admission (T0) and at 5, 10, 15, and 30 minutes post-admission.Percentage of participants with a Ramsay Sedation Scale (RSS) score ≥5, indicating emergence agitation, in the post-anesthesia care unit (PACU)

Secondary

MeasureTime frameDescription
Postoperative Pain Scores in PACUAt PACU admission (T0) and at 5, 10, 15, and 30 minutes post-admission.Numeric Rating Scale (NRS) pain scores ranging from 0 (no pain) to 10 (worst pain).

Contacts

Primary Contactİlke tamdoğan, MD
drilkeipek@gmail.com+905062916678

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026