A Study of the Effects of Intravenous Magnesium Sulphate on Anaesthesia and Analgesia in Elective General Surgery Patients

Aretaieion University Hospital

Status: Enrolling

Conditions: Pain, Acute; Pain, Postoperative; Pain, Nociceptive; Analgesia; Magnesium

Treatments: Drug: magnesium bolus followed by magnesium infusion; Drug: normal saline bolus followed by normal saline infusion; Drug: magnesium bolus followed by normal saline infusion

Study type: Interventional

Funder types: Other

Identifiers

NCT05598307

13/22-09-2021

Details and patient eligibility

About

The aim of this double-blind randomized study will be to evaluate the effect an intravenous infusion of magnesium has on recovery outcomes after elective laparoscopic cholecystectomy

Full description

Magnesium consists one of the most important electrolytes of the human body, producing effects in various systems, one of them being the central nervous system. It has been shown that the administration of intravenous magnesium sulphate during anesthesia can significantly reduce the requirements for anaesthetic and analgesic agents, perioperatively, and improve the quality of post anesthetic recovery. The present study will examine the effect of administering intravenous magnesium sulphate during anesthesia in patients undergoing elective laparoscopic cholecystectomy surgery. This is a single centre, double-blinded, randomised controlled trial in an adult population, taking place in a tertiary medical centre in Athens. The study consists of three comparison groups of equivalent population, produced by double blinded randomisation. Each comparison arm will be administered a different regimen of magnesium sulphate/placebo. During the perioperative time, depth of anaesthesia will be monitored using the Bispectral Index, (BIS™) and the nociceptive level with nociception level index (NOL®). Dosing of the anaesthetic agent, desflurane, as well as of the analgesic medication, remifentanil, will be adjusted according to the prior indices. Patients included in the study will be monitored in the PACU and the surgical ward for the first 24 hours, postoperatively. Primary outcomes include the requirements for anaesthetic and analgesic agents, time to emergence, time to extubation, time to recovery, quality of recovery variables, pain scores during the first 24 hours and adverse effects and/or complications of magnesium administration. Ethical approval for this trial has been granted by the Ethics Committee of the hospital.

Enrollment: 90 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult patents
• American Society of Anesthesiologists (ASA) class I-III
• elective laparoscopic cholecystectomy

Exclusion criteria

• body mass index (BMI) >35 kg/m2
• systematic use of analgesic agents preoperatively
• chronic pain syndromes preoperatively
• neurological or psychiatric disease on treatment
• pregnancy
• severe hepatic or renal disease
• drug or alcohol abuse
• language or communication barriers lack of informed consent

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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90 participants in 3 patient groups, including a placebo group

magnesium bolus

Active Comparator group

Description:

A bolus dose of magnesium of 40 mg/kg will be administered within 10 minutes preoperatively diluted in 100 mL of saline. Followingly, normal saline will be administered at a rate of 20 mL/h

Treatment:

Drug: magnesium bolus followed by normal saline infusion

magnesium bolus and magnesium infusion

Active Comparator group

Description:

A bolus dose of magnesium of 40 mg/kg will be administered within 10 minutes preoperatively diluted in 100 mL of saline. Followingly, 10 mg/kg/h of magnesium will be administered intraoperatively diluted in a 60 mL syringe and administered at a rate of 20 mL/h

Treatment:

Drug: magnesium bolus followed by magnesium infusion

placebo

Placebo Comparator group

Description:

100 mL of normal saline will be administered within 10 minutes preoperatively. Followingly, normal saline will be administered at a rate of 20 mL/h

Treatment:

Drug: normal saline bolus followed by normal saline infusion