Pain, PostoperativeNCT05598307
A Study of the Effects of Intravenous Magnesium Sulphate on Anaesthesia and Analgesia in Elective General Surgery Patients
A study testing magnesium bolus followed by normal saline infusion, magnesium bolus followed by magnesium infusion and normal saline bolus followed by normal saline infusion in people with Pain, Postoperative and Pain, Acute, run by Aretaieion University Hospital at 1 site in Greece.
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 Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Pain, Postoperative, Pain, Acute, Pain, Nociceptive
- What is being tested?
- magnesium bolus followed by normal saline infusion, magnesium bolus followed by magnesium infusion and normal saline bolus followed by normal saline infusion
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteGreece
- Study dates
- 1 Jun 2022to 1 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patents
- American Society of Anesthesiologists (ASA) class I-III
- elective laparoscopic cholecystectomy
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Greece1 site, 1 recruiting
- Recruiting
General Hospital of Nikea
Piraeus, Attiki, Greece, 18454
George Gantinas, MD, gadinasgio@gmail.com
Kassiani Theodoraki, PhD, DESA
About this study
Official title: The Anesthetic and Analgesic Effects of Intravenous Magnesium Sulphate in Elective Laparoscopic Cholecystectomy
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
Read the 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.
- Conditions
- Pain, Postoperative, Pain, Acute, Pain, Nociceptive, Analgesia, Magnesium
- Being tested
- magnesium bolus followed by normal saline infusion, magnesium bolus followed by magnesium infusion, normal saline bolus followed by normal saline infusion
- Medical subject headings
- Pain, Postoperative, Acute Pain, Nociceptive Pain, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
magnesium bolus followed by normal saline infusionDrug
a bolus dose of magnesium will be followed by normal saline infusion
magnesium bolus followed by magnesium infusionDrug
a bolus dose of magnesium will be followed by a magnesium infusion
normal saline bolus followed by normal saline infusionDrug
a bolus of normal saline will be followed by normal saline infusion
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: 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 Receives: Drug: normal saline bolus followed by normal saline infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
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"
Measured: 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"
Measured: 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"
Measured: 24 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2022
- Study start1 Jun 2022
- Primary completion1 Jun 2024 (estimated)
- Study completion1 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pain, PostoperativeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aretaieion University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Kassiani Theodoraki, Aretaieion University Hospital
- Investigators
- KASSIANI THEODORAKI, PhD, DESA, Principal investigator, Aretaieion University Hospital, National and Kapodistrian University of Athens, Greece
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05598307
- Sponsor's protocol ID
- 13/22-09-2021
- Status last verified
- Oct 2022
- First submitted
- 25 Oct 2022
- Last updated
- 31 Oct 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 28214095
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Anesthetic and Analgesic Effects of Intravenous Magnesium Sulphate in Elective Laparoscopic Cholecystectomy
- ClinicalTrials.gov ID
- NCT05598307
- Acronym / sponsor ID
- 13/22-09-2021
- Conditions
- Pain, Postoperative, Pain, Acute, Pain, Nociceptive, Analgesia, Magnesium
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Aretaieion University HospitalUniversity, hospital or other
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 1 Jun 2024 (estimated)
- Study completion
- 1 Jun 2024 (estimated)
- First posted
- 28 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| magnesium bolus | Active comparator | Drug: magnesium bolus followed by normal saline infusionA 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 |
| magnesium bolus and magnesium infusion | Active comparator | Drug: magnesium bolus followed by magnesium infusionA 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 |
| placebo | Placebo comparator | Drug: normal saline bolus followed by normal saline infusion100 mL of normal saline will be administered within 10 minutes preoperatively. Followingly, normal saline will be administered at a rate of 20 mL/h |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult patents
- American Society of Anesthesiologists (ASA) class I-III
- elective laparoscopic cholecystectomy
Key exclusion criteria (8 listed)
- body mass index (BMI) >35 kg/m2
- systematic use of analgesic agents preoperatively
- chronic pain syndromes preoperatively
- neurological or psychiatric disease on treatment
- pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| magnesium bolus followed by normal saline infusiona bolus dose of magnesium will be followed by normal saline infusion | Drug | magnesium bolus |
| magnesium bolus followed by magnesium infusiona bolus dose of magnesium will be followed by a magnesium infusion | Drug | magnesium bolus and magnesium infusion |
| normal saline bolus followed by normal saline infusiona bolus of normal saline will be followed by normal saline infusion | Drug | placebo |
Primary outcome
pain score on arrival to Post-Anesthesia Care Unit (PACU)
Time frame: 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"
pain score at discharge from Post-Anesthesia Care Unit (PACU)
Time frame: 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"
pain score 24 hours postoperatively
Time frame: 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"
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2022.
- Background: PubMed 28214095Haryalchi 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
KASSIANI THEODORAKI, PhD, DESA principal investigator
Aretaieion University Hospital, National and Kapodistrian University of Athens, Greece
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing magnesium bolus followed by normal saline infusion, magnesium bolus followed by magnesium infusion and normal saline bolus followed by normal saline infusion in people with Pain, Postoperative and Pain, Acute, run by Aretaieion University Hospital at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact KASSIANI THEODORAKI, PhD, DESA (+306974634162, ktheodoraki@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pain score on arrival to Post-Anesthesia Care Unit (PACU) (time frame: immediately postoperatively). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05598307, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Oct 2022.