Intravenous Administration of Magnesium Sulfate in Hysterectomy Cases

NCT05644873 | Completed

• 1 other identifier: ITamdogan
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Abdominal Hysterectomy; General Anesthesia; Magnesium Sulfate

Keywords

postoperative pain; intravenous magnesium sulfate

Outcome Measures

Primary Outcomes (1)

• The primary outcome of this study was total opioid consumption in the first 24 hours postoperatively

  IV patient-controlled analgesia (PCA) device with 5 µg/mL fentanyl was used for postoperative analgesia and was administered as a standard procedure to all patients. The bolus dose was set as 10 µg, the louckout time as 5 min, and the one-hour limit as 50 µg. In the event that the Numeric Rating Scale (NRS) pain score ≥ 4, rescue analgesia with IV tramadol 0.5 mg/kg (maximum daily dose 400 mg) was administeredThe total opioid consumption was calculated as morphine milligram equivalents (MME) using the GlobalRPH opioid equivalency calculator. Conversion factors used were: * Fentanyl: 0.1 mg IV fentanyl = 10 mg IV morphine * Tramadol: 100 mg tramadol = 10 mg morphine

  Postoperative Day 1

Secondary Outcomes (2)

• Post-operative acute pain

  Postoperative Day 1

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

  Postoperative Day 1

Study Arms (2)

Magnesium sulfate

ACTIVE COMPARATOR

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

Placebo

ACTIVE COMPARATOR

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

Drug: control group saline

Interventions

magnesium sulfate group DRUG

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

Magnesium sulfate

control group saline DRUG

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

Placebo

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ondokuz Mayıs University: lead

Study Sites (1)

Ondokuz Mayıs University Faculty of Medicine

Samsun, Turkey (Türkiye)

Location

Related Publications (4)

• 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.

  PMID: 23121612 RESULT

• 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.

  PMID: 16311277 RESULT

• 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.

  PMID: 33762190 RESULT

• 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.

  PMID: 27687417 RESULT

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Magnesium Sulfate; Sodium Chloride

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Magnesium Compounds; Inorganic Chemicals; Sulfates; Sulfuric Acids; Sulfur Acids; Sulfur Compounds; Chlorides; Hydrochloric Acid; Chlorine Compounds; Sodium Compounds

Study Officials

• ilke tamdoğan

  ndokuz Mayıs University Faculty of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: The patients were randomly divided into two groups according to a 1:1 randomization ratio using opaque sealed envelopes before surgery. Study randomization was performed using computer generated randomization codes by SPSS v23.0 (IBM, New York, USA). Each patient was asked to choose an envelope and the patients were assigned to the study according to the group specified in the envelope. The drugs to be used were prepared 30 minutes before the surgery by the nurse who did not participate in the study in the drug preparation room. Everyone involved in this study, including patients, researchers, the anesthesiologist responsible for anesthesia management, and the surgeon, remained blind to group distribution during the study.

Study Record Dates

• First Submitted: December 1, 2022
• First Posted: December 9, 2022
• Study Start: November 15, 2023
• Primary Completion: February 20, 2024
• Study Completion: April 30, 2024
• Last Updated: May 21, 2025

Record last verified: 2025-05

Locations

TU (1)