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

NCT ID: NCT05598307

Last Updated: 2022-10-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-06-01

Study Completion Date

2024-06-01

Brief Summary

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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

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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.

Conditions

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Pain, Postoperative Pain, Acute Pain, Nociceptive Analgesia Magnesium

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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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

Group Type ACTIVE_COMPARATOR

magnesium bolus followed by normal saline infusion

Intervention Type DRUG

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

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

Group Type ACTIVE_COMPARATOR

magnesium bolus followed by magnesium infusion

Intervention Type DRUG

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

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

Group Type PLACEBO_COMPARATOR

normal saline bolus followed by normal saline infusion

Intervention Type DRUG

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

Interventions

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magnesium bolus followed by normal saline infusion

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

Intervention Type DRUG

magnesium bolus followed by magnesium infusion

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

Intervention Type DRUG

normal saline bolus followed by normal saline infusion

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Aretaieion University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Dr Kassiani Theodoraki

Professor of Anesthesiology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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KASSIANI THEODORAKI, PhD, DESA

Role: PRINCIPAL_INVESTIGATOR

Aretaieion University Hospital, National and Kapodistrian University of Athens, Greece

Locations

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General Hospital of Nikea

Piraeus, Attiki, Greece, Greece

Site Status RECRUITING

Countries

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Greece

Central Contacts

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KASSIANI THEODORAKI, PhD, DESA

Role: CONTACT

Phone: +306974634162

Email: [email protected]

Facility Contacts

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George Gantinas, MD

Role: primary

References

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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.

Reference Type BACKGROUND
PMID: 28214095 (View on PubMed)

Other Identifiers

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13/22-09-2021

Identifier Type: -

Identifier Source: org_study_id