Intravenous Administration of Magnesium Sulfate in Laparoscopic Hysterectomy Cases

NCT05826119 | Completed

• 1 other identifier: drilke
• Study Type: interventional
• Target: 60
• 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

Laparoscopic Hysterectomy; Magnesium Sulfate; General Anesthesia

Keywords

intravenous magnesium sulfate; lararoscopic hysterectomy

Outcome Measures

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).

  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: Placebo

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

Placebo 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Interventions

Magnesium Sulfate; Sodium Chloride

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

  Ondokuz 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: April 11, 2023
• First Posted: April 24, 2023
• Study Start: January 20, 2024
• Primary Completion: March 30, 2024
• Study Completion: June 15, 2024
• Last Updated: December 19, 2025

Record last verified: 2025-12

Locations

TU (1)