Lumbar Disc HerniationNCT07139847
Magnesium Sulfate for Prevention of Emergence Agitation in Lumbar Disc Surgery
An observational study of Lumbar Disc Herniation and Emergence Agitation, run by Ondokuz Mayıs University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Lumbar Disc Herniation, Emergence Agitation, Magnesium Sulfate
- What is being tested?
- Magnesium Sulfate Infusion and 0.9% Saline Infusion
- Type of treatment
- Injection or infusion
- How many people
- 70 participants
- Where
- No sites listed yet
- Study dates
- 5 Jul 2026to 30 Sep 2026
- How long will I take part?
- 1 Month
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Effect of Intraoperative Magnesium Infusion on Postoperative Emergence Agitation in Patients Undergoing Lumbar Microdiscectomy
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.
Read the detailed description
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.
- Being tested
- Magnesium Sulfate Infusion, 0.9% Saline Infusion
- Keywords
- Magnesium Sulfate, Lumbar Disc Herniation, Postoperative Complications
- Medical subject headings
- Intervertebral Disc Displacement, Emergence Delirium, Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnesium Sulfate InfusionDrug
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 InfusionDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: 0.9% Saline Infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: At PACU admission (T0) and at 5, 10, 15, and 30 minutes post-admission.
Secondary outcomes (1)
Postoperative Pain Scores in PACU
Numeric Rating Scale (NRS) pain scores ranging from 0 (no pain) to 10 (worst pain).
Measured: At PACU admission (T0) and at 5, 10, 15, and 30 minutes post-admission.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2025
- Study start5 Jul 2026 (estimated)
- Primary completion30 Aug 2026 (estimated)
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Lumbar Disc HerniationStudies of the same condition, open and under way.
- More trials run by Ondokuz Mayıs UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 70 participants (estimated)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- Ondokuz Mayıs University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ilke Tamdogan, Ondokuz Mayıs University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07139847
- Sponsor's protocol ID
- GUAH-MAG-2025-01
- Status last verified
- Aug 2025
- First submitted
- 15 Aug 2025
- Last updated
- 25 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared due to privacy concerns and institutional policies.
Publications
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.
PubMed 20526708Soltész, 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
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Intraoperative Magnesium Infusion on Postoperative Emergence Agitation in Patients Undergoing Lumbar Microdiscectomy
- ClinicalTrials.gov ID
- NCT07139847
- Acronym / sponsor ID
- GUAH-MAG-2025-01
- Keywords
- Magnesium Sulfate, Lumbar Disc Herniation, Postoperative Complications
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Ondokuz Mayıs UniversityUniversity, hospital or other
- Study start
- 5 Jul 2026 (estimated)
- Primary completion
- 30 Aug 2026 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 24 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 1 Month
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Magnesium Sulfate Infusion | – | Drug: Magnesium Sulfate InfusionPatients 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. |
| 0.9% Saline Infusion | – | Drug: 0.9% Saline InfusionPatients 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- Severe cardiovascular disease
- History of psychiatric disorder
- Neuromuscular disease
- Pregnancy or breastfeeding
- Hepatic or renal dysfunction
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Magnesium Sulfate InfusionMagnesium 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 | Magnesium Sulfate Infusion |
| 0.9% Saline Infusionntravenous 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. | Drug | 0.9% Saline Infusion |
Primary outcome
Incidence of Emergence Agitation in the PACU
Time frame: At 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)
1 secondary outcome
Postoperative Pain Scores in PACU
Time frame: At PACU admission (T0) and at 5, 10, 15, and 30 minutes post-admission.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2026.
- Results publication1. 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
- Results publication: PubMed 20526708Yu 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.
- Results publicationSoltész, 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
- Individual participant dataSharing planned: No. Individual participant data will not be shared due to privacy concerns and institutional policies.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
An observational study of Lumbar Disc Herniation and Emergence Agitation, run by Ondokuz Mayıs University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 25 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact İlke tamdoğan, MD (+905062916678, drilkeipek@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Emergence Agitation in the PACU (time frame: At PACU admission (T0) and at 5, 10, 15, and 30 minutes post-admission.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07139847, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2026.