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

NCT05598307 | Unknown

• 1 other identifier: 13/22-09-2021
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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

Conditions

Pain, Postoperative; Pain, Acute; Pain, Nociceptive; Analgesia; Magnesium

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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

Other Outcomes (9)

• time to first request for analgesia

  during stay in Post-Anesthesia Care Unit (PACU), approximately 1 hour postoperatively

• morphine consumption in Post-Anesthesia Care Unit (PACU)

  immediately postoperatively

• pethidine consumption in the first 48 hours

  48 hours postoperatively

Study Arms (3)

magnesium bolus

ACTIVE COMPARATOR

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

magnesium bolus and magnesium infusion

ACTIVE COMPARATOR

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

placebo

PLACEBO COMPARATOR

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

Interventions

magnesium bolus followed by normal saline infusion DRUG

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

magnesium bolus

magnesium bolus followed by magnesium infusion DRUG

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

magnesium bolus and magnesium infusion

normal saline bolus followed by normal saline infusion DRUG

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

placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patents
• American Society of Anesthesiologists (ASA) class I-III
• elective laparoscopic cholecystectomy

You may not qualify if:

• 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

Sponsors & Collaborators

• Aretaieion University Hospital: lead

Study Sites (1)

General Hospital of Nikea

Piraeus, Attiki, Greece, 18454, Greece

RECRUITING

Related 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.

  PMID: 28214095 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative; Acute Pain; Nociceptive Pain; Agnosia

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Study Officials

• KASSIANI THEODORAKI, PhD, DESA

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

KASSIANI THEODORAKI, PhD, DESA

CONTACT

+306974634162; ktheodoraki@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Anesthesiology

Study Record Dates

• First Submitted: October 25, 2022
• First Posted: October 28, 2022
• Study Start: June 1, 2022
• Primary Completion: June 1, 2024
• Study Completion: June 1, 2024
• Last Updated: October 31, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

GR (1)