Clinical trial NCT05598307: A Study of the Effects of Intravenous Magnesium Sulphate on Anaesthesia and Analgesia in Elective General Surgery Patients
Official title: The Anesthetic and Analgesic Effects of Intravenous Magnesium Sulphate in Elective Laparoscopic Cholecystectomy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pain, Postoperative
Pain, Acute
Pain, Nociceptive
Analgesia
Magnesium
Lead sponsor: Aretaieion University Hospital
Sponsor class: OTHER
First posted: 2022-10-28
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: pain score on arrival to Post-Anesthesia Care Unit (PACU)
timeFrame: immediately postoperatively
measure: pain score at discharge from Post-Anesthesia Care Unit (PACU)
timeFrame: at discharge from Post Anesthesia Care Unit (PACU), approximately 1 hour postoperatively
measure: pain score 24 hours postoperatively
timeFrame: 24 hours postoperatively
Secondary outcomes:
Other outcomes:
measure: time to first request for analgesia
timeFrame: during stay in Post-Anesthesia Care Unit (PACU), approximately 1 hour postoperatively
measure: morphine consumption in Post-Anesthesia Care Unit (PACU)
timeFrame: immediately postoperatively
measure: pethidine consumption in the first 48 hours
timeFrame: 48 hours postoperatively
measure: remifentanil requirement during surgery
timeFrame: intraoperatively
measure: number of participants experiencing side effects intraoperatively
timeFrame: intraoperatively
measure: number of participants experiencing side effects postoperatively
timeFrame: 48 hours postoperatively
measure: time to emergence
timeFrame: end of operation, approximately 1 hour after start of surgery
measure: time to extubation
timeFrame: end of operation, approximately 1 hour after start of surgery
measure: duration of nociception level<25 intraoperatively
timeFrame: intraoperatively
Locations:
city: Piraeus
country: Greece
facility: General Hospital of Nikea
state: Attiki, Greece
Study officials:
affiliation: Aretaieion University Hospital, National and Kapodistrian University of Athens, Greece
name: KASSIANI THEODORAKI, PhD, DESA
role: PRINCIPAL_INVESTIGATOR
References:
citation: Haryalchi K, Abedinzade M, Khanaki K, Mansour Ghanaie M, Mohammad Zadeh F. Whether preventive low dose magnesium sulphate infusion has an influence on postoperative pain perception and the level of serum beta-endorphin throughout the total abdominal hysterectomy. Rev Esp Anestesiol Reanim. 2017 Aug-Sep;64(7):384-390. doi: 10.1016/j.redar.2016.11.009. Epub 2017 Feb 14. English, Spanish.