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

Sponsor
Aretaieion University Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT05598307
Collaborator
(none)
90
1
3
24
3.7

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
  • Drug: magnesium bolus followed by normal saline infusion
  • Drug: magnesium bolus followed by magnesium infusion
  • Drug: normal saline bolus followed by normal saline infusion
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
90 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
The Anesthetic and Analgesic Effects of Intravenous Magnesium Sulphate in Elective Laparoscopic Cholecystectomy
Actual Study Start Date :
Jun 1, 2022
Anticipated Primary Completion Date :
Jun 1, 2024
Anticipated Study Completion Date :
Jun 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: magnesium bolus

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

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

Active Comparator: magnesium bolus and magnesium infusion

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

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

Placebo Comparator: placebo

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

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

Outcome Measures

Primary Outcome Measures

  1. pain score on arrival to Post-Anesthesia Care Unit (PACU) [immediately postoperatively]

    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"

  2. pain score at discharge from Post-Anesthesia Care Unit (PACU) [at discharge from Post Anesthesia Care Unit (PACU), approximately 1 hour postoperatively]

    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"

  3. pain score 24 hours postoperatively [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"

Other Outcome Measures

  1. time to first request for analgesia [during stay in Post-Anesthesia Care Unit (PACU), approximately 1 hour postoperatively]

    the time for the first patient request for analgesia will be noted

  2. morphine consumption in Post-Anesthesia Care Unit (PACU) [immediately postoperatively]

    mg of morphine requested during patient PACU stay

  3. pethidine consumption in the first 48 hours [48 hours postoperatively]

    patients will be followed for cumulative pethidine consumption for 48 hours postoperatively

  4. remifentanil requirement during surgery [intraoperatively]

    dose of required remifentanil intraoperatively to maintain systolic arterial blood pressure and heart rate within the 20% of baseline value

  5. number of participants experiencing side effects intraoperatively [intraoperatively]

    patients will be monitored for side-effects of the administered agents intraoperatively

  6. number of participants experiencing side effects postoperatively [48 hours postoperatively]

    patients will be monitored for side-effects of the administered agents postoperatively

  7. time to emergence [end of operation, approximately 1 hour after start of surgery]

    time from desflurane discontinuation to first patient response (eye opening)

  8. time to extubation [end of operation, approximately 1 hour after start of surgery]

    time from desflurane discontinuation to tracheal extubation

  9. duration of nociception level<25 intraoperatively [intraoperatively]

    nociception level (NOL) is a device that measures the status of analgesia intraoperatively. Levels<25 suggest adequate intraoperatively analgesia

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 General Hospital of Nikea Piraeus Attiki, Greece Greece 18454

Sponsors and Collaborators

  • Aretaieion University Hospital

Investigators

  • Principal Investigator: KASSIANI THEODORAKI, PhD, DESA, Aretaieion University Hospital, National and Kapodistrian University of Athens, Greece

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Dr Kassiani Theodoraki, Professor of Anesthesiology, Aretaieion University Hospital
ClinicalTrials.gov Identifier:
NCT05598307
Other Study ID Numbers:
  • 13/22-09-2021
First Posted:
Oct 28, 2022
Last Update Posted:
Oct 31, 2022
Last Verified:
Oct 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 31, 2022