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

Pain, Postoperative Clinical Trial

Official title:

The Anesthetic and Analgesic Effects of Intravenous Magnesium Sulphate in Elective Laparoscopic Cholecystectomy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05598307
• Other study ID #: 13/22-09-2021
• Status: Recruiting
• Phase: N/A
• Start date: June 1, 2022
• Est. completion date: June 1, 2024

Study information

• Verified date: October 2022
• Source: Aretaieion University Hospital
• Contact: KASSIANI THEODORAKI, PhD, DESA
• Phone: +306974634162
• Email: ktheodoraki[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: June 1, 2024
• Est. primary completion date: June 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Pain
• Analgesia
• Magnesium
• Nociceptive Pain
• Pain, Acute
• Pain, Postoperative

Intervention

Drug:
• magnesium bolus followed by normal saline infusion
a bolus dose of magnesium will be followed by normal saline infusion
• magnesium bolus followed by magnesium infusion
a bolus dose of magnesium will be followed by a magnesium infusion
• normal saline bolus followed by normal saline infusion
a bolus of normal saline will be followed by normal saline infusion

Locations

Country	Name	City	State
Greece	General Hospital of Nikea	Piraeus	Attiki, Greece

Sponsors (1)

Lead Sponsor	Collaborator
Aretaieion University Hospital

Country where clinical trial is conducted

Greece, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	time to first request for analgesia	the time for the first patient request for analgesia will be noted	during stay in Post-Anesthesia Care Unit (PACU), approximately 1 hour postoperatively
Other	morphine consumption in Post-Anesthesia Care Unit (PACU)	mg of morphine requested during patient PACU stay	immediately postoperatively
Other	pethidine consumption in the first 48 hours	patients will be followed for cumulative pethidine consumption for 48 hours postoperatively	48 hours postoperatively
Other	remifentanil requirement during surgery	dose of required remifentanil intraoperatively to maintain systolic arterial blood pressure and heart rate within the 20% of baseline value	intraoperatively
Other	number of participants experiencing side effects intraoperatively	patients will be monitored for side-effects of the administered agents intraoperatively	intraoperatively
Other	number of participants experiencing side effects postoperatively	patients will be monitored for side-effects of the administered agents postoperatively	48 hours postoperatively
Other	time to emergence	time from desflurane discontinuation to first patient response (eye opening)	end of operation, approximately 1 hour after start of surgery
Other	time to extubation	time from desflurane discontinuation to tracheal extubation	end of operation, approximately 1 hour after start of surgery
Other	duration of nociception level<25 intraoperatively	nociception level (NOL) is a device that measures the status of analgesia intraoperatively. Levels<25 suggest adequate intraoperatively analgesia	intraoperatively
Primary	pain score on arrival to Post-Anesthesia Care Unit (PACU)	pain score by the use of Numeric Rating Scale (NRS) on arrival to PACU, ranging from 0 to 10, where 0 means "no pain" and 10 means "worst pain imaginable"	immediately postoperatively
Primary	pain score at discharge from Post-Anesthesia Care Unit (PACU)	pain score by the use of Numeric Rating Scale (NRS) at discharge from PACU, ranging from 0 to 10, where 0 means "no pain" and 10 means "worst pain imaginable"	at discharge from Post Anesthesia Care Unit (PACU), approximately 1 hour postoperatively
Primary	pain score 24 hours postoperatively	pain score by the use of Numeric Rating Scale (NRS) 24 hours postoperatively, ranging from 0 to 10, where 0 means "no pain" and 10 means "worst pain imaginable"	24 hours postoperatively