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CompletedNCT05826119MgSO4Updated Dec 19, 2025

Intravenous Administration of Magnesium Sulfate in Laparoscopic Hysterectomy Cases

An interventional study of magnesium sulfate group and Placebo in Laparoscopic Hysterectomy, Magnesium Sulfate and General Anesthesia, sponsored by Ondokuz Mayıs University. Completed at 1 site in Turkey (Türkiye). Open to female participants aged 20 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-12-19.

Sponsored by Ondokuz Mayıs University · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
20 Years to 70 Years
Sex
Female
01

Study summary

In our study, it was aimed to show the contribution of intraoperative intravenous magnesium sulfate administration to peroperative opioid consumption and postoperative analgesia.

Read the detailed description

Postsurgical pain is one of the most important issues that could impress on postoperative peace and comfort. Laparoscopic hysterectomy associated with intense inflammatory response, resulting in moderate to severe postoperative pain perception The major goal in postoperative pain management is to minimize the dose of medications and lessen side effects, while still providing adequate analgesia. Postoperative pain relief leads to earlier mobilization, shortened hospital staying, reduced hospital costs, and increased patient satisfaction Narcotics are the most common analgesics which are used after the surgeries. But anesthetists are always looking for replaceable methods with fewer side effects and cost . It seems adjuvant analgesics are those desirable replacements. Nowadays there have been many debates on the role of adjuvant analgesics on postoperative pain relief. One way to use adjuvant analgesics is preventive method Preventive analgesia is a method initiated before anesthetic procedure in order to reduce the physiological consequences of nociceptive stimulation and medical adverse effects and has been defined as an antinociceptive treatment that prevents establishment of altered central processing of afferent input from injuries. One of the intravenous adjuvant that has been shown potential in preventive analgesia is magnesium sulfate that could be administered with multiple routes or methods Mg has been used for many years in anesthesia and cardiology as an anticonvulsant or antiarrhythmic drug. The mechanism of the analgesic effect of Mg is not clear but interference with calcium channels and N-methyl-D-aspartate (NMDA) receptor seem to play an important role. It seems that analgesic mechanism of NMDA-antagonists is made by preventing nociceptive central sensitization. Another suggesting mechanism is the role of it on reduction of catecholamine release with sympathetic stimulation, thereby decreasing peripheral nociception or the stress response to the surgery. Data illustrate that the NMDA receptor antagonists "like Mg sulfate" have an effect on pain threshold and could prevent pain perception even with low doses (preventive doses) In our study, investigators aimed to determine the contribution of magnesium sulfate to postoperative analgesia in abdominal hysterectomy by considering its mechanism of action.

The patients were divided into two groups as magnesium sulfate administered and non-administered The magnesium group received a bolus of 20 mg/kg of magnesium sulfate in 100 mL of saline for 15 minutes before induction, followed by a continuous infusion of 20 mg/kg/hr until the skin was closed. The same volume of isotonic saline for the control group was administered as indicated in the magnesium group.

02

Conditions studied

  • Laparoscopic Hysterectomy
  • Magnesium Sulfate
  • General Anesthesia

Keywords

  • intravenous magnesium sulfate
  • lararoscopic hysterectomy
03

In context

Lead sponsor

Ondokuz Mayıs University is the lead sponsor of 262 studies on the registry; 68 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
20 Years to 70 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Inclusion criteria

  • Patient undergoing abdominal hysterectomy
  • Between the ages of 20-70,
  • ASA I- II

Exclusion criteria

Exclusion Criteria:

  • Presence of hepatic and renal dysfunction,
  • Presence of cardiac arrhythmia or other cardiac comorbidity,
  • Neurological and psychiatric disorder,
  • Chronic use of calcium and beta blockers,
  • Drug or alcohol abuse,
  • Pregnancy and lactation status,
  • Patients with a history of allergy to any drug included in the study protocol
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Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
60 participants (actual)

Study arms

  • Active comparator
    Magnesium sulfate

    Before induction, a bolus of 20 mg/kg magnesium sulfate in 100 mL saline was administered for 15 minutes, followed by a continuous infusion of 20 mg/kg/hour until the skin was closed.

    Drug: magnesium sulfate group

  • Active comparator
    Placebo

    The control group received only 100 ml of saline 15 minutes before induction.

    Drug: Placebo

Interventions

  • Drugmagnesium sulfate group

    Anesthesia induction was provided with propofol (2mg/kg), fentanyl (2mcg/kg). Intubation was performed after administration of 0.6 mg/kg rocuronium with an appropriate endotracheal tube. Anesthesia was maintained using AIR/O2 (50%/50%), 1 minimum alveolar concentration (MAC) sevoflurane, 0.1-0.25 mcg/kg/min remifentanil infusion. The target BIS value was kept between 40 and 50. Systolic blood pressure (SBP) \<90mmHg or \<20% of baseline was considered hypotension; remifentanil infusion was reduced. If no response was obtained, 5-10 mg of IV ephedrine was administered. HR \< 45 beats/min was evaluated as bradycardia; IV atropine 0.5 mg was planned The magnesium group received a bolus of 20 mg/kg of magnesium sulfate in 100 mL of saline for 15 minutes prior to induction, followed by a continuous infusion of 20 mg/kg/hr until skin closure.

    Also known as: magnesium sulfate

  • DrugPlacebo

    Anesthesia induction was provided with propofol (2mg/kg), fentanyl (2mcg/kg). Intubation was performed after administration of 0.6 mg/kg rocuronium with an appropriate endotracheal tube. Anesthesia was maintained using AIR/O2 (50%/50%), 1 minimum alveolar concentration (MAC) sevoflurane, 0.1-0.25 mcg/kg/min remifentanil infusion. The target BIS value was kept between 40 and 50. Systolic blood pressure (SBP) \<90mmHg or \<20% of baseline was considered hypotension; remifentanil infusion was reduced. If no response was obtained, 5-10 mg of IV ephedrine was administered. HR \< 45 beats/min was evaluated as bradycardia; IV atropine 0.5 mg was planned The same volume of isotonic saline for the control group was administered as indicated in the magnesium group.

    Also known as: saline

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What researchers measure

Primary outcomes

  1. Fentanyl consumption in the first 24 hours after surgery

    Fentanyl consumption in the first 24 hours was measured. Patients were able to request opioids via a PCA device when their VAS score is above 4 at rest and during activity (coughing and walking).

    Time frame: Postoperative Day 1

Secondary outcomes

  1. Post-operative acute pain

    Pain status at rest and while activity (coughing and walking) was assessed by VAS scores at 0, 2, 4, 6, 8, 12 and 24 hours after surgery. The VAS is an 11-point numeric scale which ranges from 0 to 10 at rest and during activity.

    Time frame: Postoperative Day 1

  2. The incidences of post-operative nausea and vomiting (PONV)

    The severity of postoperative nausea and vomiting (PONV) was assessed using a Verbal Descriptive Scale(VDS) at 0, 2, 4, 6, 8, 12 and 24, hours after surgery. If a score of 3 or more is recorded, ondansetron 0,1 mg/kg iv was administered.

    Time frame: Postoperative Day 1

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Study locations

1 site
  • Ondokuz Mayıs University Faculty of Medicine
    Samsun, Turkey (Türkiye)
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References and documents

Publications

  • Albrecht E, Kirkham KR, Liu SS, Brull R. Peri-operative intravenous administration of magnesium sulphate and postoperative pain: a meta-analysis. Anaesthesia. 2013 Jan;68(1):79-90. doi: 10.1111/j.1365-2044.2012.07335.x. Epub 2012 Nov 1. PubMed 23121612 ↗
  • Seyhan TO, Tugrul M, Sungur MO, Kayacan S, Telci L, Pembeci K, Akpir K. Effects of three different dose regimens of magnesium on propofol requirements, haemodynamic variables and postoperative pain relief in gynaecological surgery. Br J Anaesth. 2006 Feb;96(2):247-52. doi: 10.1093/bja/aei291. Epub 2005 Nov 25. PubMed 16311277 ↗
  • Benevides ML, Fialho DC, Linck D, Oliveira AL, Ramalho DHV, Benevides MM. Intravenous magnesium sulfate for postoperative analgesia after abdominal hysterectomy under spinal anesthesia: a randomized, double-blind trial. Braz J Anesthesiol. 2021 Sep-Oct;71(5):498-504. doi: 10.1016/j.bjane.2021.01.008. Epub 2021 Mar 21. PubMed 33762190 ↗
  • Sousa AM, Rosado GM, Neto Jde S, Guimaraes GM, Ashmawi HA. Magnesium sulfate improves postoperative analgesia in laparoscopic gynecologic surgeries: a double-blind randomized controlled trial. J Clin Anesth. 2016 Nov;34:379-84. doi: 10.1016/j.jclinane.2016.05.006. Epub 2016 Jun 5. PubMed 27687417 ↗

Study documents

  • Study protocol · Sep 5, 2023
  • Statistical analysis plan · Sep 1, 2023
  • Informed consent form · Sep 5, 2023

Documents are hosted by the registry — open the source record to download them.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 19, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05826119
Lead sponsor
Ondokuz Mayıs University
Responsible party
Ilke Tamdogan (Principal Investigator, Ondokuz Mayıs University) — Principal investigator
First posted
Apr 24, 2023
Start date
Jan 20, 2024
Primary completion
Mar 30, 2024
Completion
Jun 15, 2024
Last update
Dec 19, 2025

Study contacts

ilke tamdoğan
principal investigator · Ondokuz Mayıs University Faculty of Medicine

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.

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