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Magnesium Sulfate for Prevention of Emergence Agitation in Lumbar Disc Surgery

NCT07139847 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2025-12-12

No results posted yet for this study

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

Interventions

DRUG

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.

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.

Sponsors & Collaborators

  • Ondokuz Mayıs University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-12-30
Primary Completion
2026-07-30
Completion
2026-12-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07139847 on ClinicalTrials.gov