Clinical trial NCT05826119: Intravenous Administration of Magnesium Sulfate in Laparoscopic Hysterectomy Cases
Official title: The Effect of Intravenous Magnesium Sulfate Use on Intraoperative Remifentanil Consumption and Postoperative Pain in Laparoscopic Hysterectomy Cases
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Laparoscopic Hysterectomy
Magnesium Sulfate
General Anesthesia
Keywords: intravenous magnesium sulfate
lararoscopic hysterectomy
Lead sponsor: Ondokuz Mayıs University
Sponsor class: OTHER
First posted: 2023-04-24
Enrollment: 60
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility criteria: Inclusion Criteria:

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

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

Primary outcomes:
measure: Fentanyl consumption in the first 24 hours after surgery
timeFrame: Postoperative Day 1
Secondary outcomes:
measure: Post-operative acute pain
timeFrame: Postoperative Day 1
measure: The incidences of post-operative nausea and vomiting (PONV)
timeFrame: Postoperative Day 1
Other outcomes:
Locations:
city: Samsun
country: Turkey
facility: Ondokuz Mayıs University Faculty of Medicine
Study officials:
affiliation: Ondokuz Mayıs University Faculty of Medicine
name: ilke tamdoğan
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.