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

Primary Purpose

Pain, Postoperative, Pain, Acute, Pain, Nociceptive

Status
Recruiting
Phase
Not Applicable
Locations
Greece
Study Type
Interventional
Intervention
magnesium bolus followed by normal saline infusion
magnesium bolus followed by magnesium infusion
normal saline bolus followed by normal saline infusion
Sponsored by
Aretaieion University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pain, Postoperative

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • General Hospital of NikeaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

magnesium bolus

magnesium bolus and magnesium infusion

placebo

Arm 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

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

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

Outcomes

Primary Outcome Measures

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"
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"
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"

Secondary Outcome Measures

Full Information

First Posted
October 25, 2022
Last Updated
October 27, 2022
Sponsor
Aretaieion University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05598307
Brief Title
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

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 1, 2022 (Actual)
Primary Completion Date
June 1, 2024 (Anticipated)
Study Completion Date
June 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Aretaieion University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative, Pain, Acute, Pain, Nociceptive, Analgesia, Magnesium

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
magnesium bolus
Arm Type
Active Comparator
Arm 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
Arm Title
magnesium bolus and magnesium infusion
Arm Type
Active Comparator
Arm 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
Arm Title
placebo
Arm Type
Placebo Comparator
Arm 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
Intervention Type
Drug
Intervention Name(s)
magnesium bolus followed by normal saline infusion
Intervention Description
a bolus dose of magnesium will be followed by normal saline infusion
Intervention Type
Drug
Intervention Name(s)
magnesium bolus followed by magnesium infusion
Intervention Description
a bolus dose of magnesium will be followed by a magnesium infusion
Intervention Type
Drug
Intervention Name(s)
normal saline bolus followed by normal saline infusion
Intervention Description
a bolus of normal saline will be followed by normal saline infusion
Primary Outcome Measure Information:
Title
pain score on arrival to Post-Anesthesia Care Unit (PACU)
Description
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"
Time Frame
immediately postoperatively
Title
pain score at discharge from Post-Anesthesia Care Unit (PACU)
Description
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"
Time Frame
at discharge from Post Anesthesia Care Unit (PACU), approximately 1 hour postoperatively
Title
pain score 24 hours postoperatively
Description
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"
Time Frame
24 hours postoperatively
Other Pre-specified Outcome Measures:
Title
time to first request for analgesia
Description
the time for the first patient request for analgesia will be noted
Time Frame
during stay in Post-Anesthesia Care Unit (PACU), approximately 1 hour postoperatively
Title
morphine consumption in Post-Anesthesia Care Unit (PACU)
Description
mg of morphine requested during patient PACU stay
Time Frame
immediately postoperatively
Title
pethidine consumption in the first 48 hours
Description
patients will be followed for cumulative pethidine consumption for 48 hours postoperatively
Time Frame
48 hours postoperatively
Title
remifentanil requirement during surgery
Description
dose of required remifentanil intraoperatively to maintain systolic arterial blood pressure and heart rate within the 20% of baseline value
Time Frame
intraoperatively
Title
number of participants experiencing side effects intraoperatively
Description
patients will be monitored for side-effects of the administered agents intraoperatively
Time Frame
intraoperatively
Title
number of participants experiencing side effects postoperatively
Description
patients will be monitored for side-effects of the administered agents postoperatively
Time Frame
48 hours postoperatively
Title
time to emergence
Description
time from desflurane discontinuation to first patient response (eye opening)
Time Frame
end of operation, approximately 1 hour after start of surgery
Title
time to extubation
Description
time from desflurane discontinuation to tracheal extubation
Time Frame
end of operation, approximately 1 hour after start of surgery
Title
duration of nociception level<25 intraoperatively
Description
nociception level (NOL) is a device that measures the status of analgesia intraoperatively. Levels<25 suggest adequate intraoperatively analgesia
Time Frame
intraoperatively

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
KASSIANI THEODORAKI, PhD, DESA
Phone
+306974634162
Email
ktheodoraki@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
KASSIANI THEODORAKI, PhD, DESA
Organizational Affiliation
Aretaieion University Hospital, National and Kapodistrian University of Athens, Greece
Official's Role
Principal Investigator
Facility Information:
Facility Name
General Hospital of Nikea
City
Piraeus
State/Province
Attiki, Greece
ZIP/Postal Code
18454
Country
Greece
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
George Gantinas, MD
Email
gadinasgio@gmail.com
First Name & Middle Initial & Last Name & Degree
Kassiani Theodoraki, PhD, DESA

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
28214095
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.
Results Reference
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A Study of the Effects of Intravenous Magnesium Sulphate on Anaesthesia and Analgesia in Elective General Surgery Patients

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