NCT03558516

Magnesium and Intraoperative Blood Loss in Meningioma Surgery

Completed Phase 3 Results posted Last updated 13 July 2020

What this trial tests

Phase 3 trial testing Magnesium group in Meningioma in 80 participants. Completed in 18 February 2020.

Timeline

1 August 2018

Primary endpoint
3 February 2020

18 February 2020

Quick facts

Lead sponsor	Mahidol University
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	other
Enrollment	80
Start date	1 August 2018
Primary completion	3 February 2020
Estimated completion	18 February 2020
Sites	1 location across Thailand

Drugs / interventions tested

• Magnesium group — full drug profile →
• Normal saline group

Conditions studied

• Meningioma — all drugs for Meningioma →

Sponsor

Mahidol University

Who can join

Adults 18 to 70, any sex, with Meningioma. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Intraoperative Blood Loss Primary · Intraoperative period from skin was incised to the skin was closure, an average 5 hours.

We measure the amount of blood loss in the operative room in suction box, gauze and plastic bag. The unit measure is millimeter.

Group	Value	95% CI
Group NSS	510	100 – 1600
Group Mg	500	70 – 2300

Intraoperative Packed Red Cell (PRC) Transfusion Secondary · Intraoperative period from skin was incised to the skin was closure, an average 5 hours.

The amount of blood transfusion in patient who required PRC transfusion intraoperatively.

Group	Value	95% CI
Group NSS	2	1 – 4
Group Mg	1	1 – 3

Postoperative MOCA Score Secondary · Postoperative day 3-7

MOCA or Montreal Cognitive Assessment is a screening instrument used to facilitate the assessment of cognitive impairment. MOCA scores range between 0-30, do higher values represent a better outcome. A score of 26 or over is considered to be normal. We measure Montreal assessment score for assess cognitive function after operation at postoperative day 3-7.

Group	Value	95% CI
Group NSS	23	15 – 28
Group Mg	25	8 – 30

Sevoflurane Requirement Secondary · Intraoperative period from skin was incised to the skin was closure, an average 5 hours.

Amount of sevoflurane agents usage during surgery. The unit of measurement of volatile agent is minimum alveolar concentration (MAC). 1 MAC-hour was defined as 2% of sevoflurane for 1 hour duration.

Group	Value	95% CI
Group NSS	0.65	± 0.12
Group Mg	0.66	± 0.17

Fentanyl Requirement Secondary · Intraoperative period from skin was incised to the skin was closure, an average 5 hours.

Amount of fentanyl usage during surgery

Group	Value	95% CI
Group NSS	0.65	± 0.19
Group Mg	0.6	± 0.18

Cis-atracurium Requirement Secondary · Intraoperative period from skin was incised to the skin was closure, an average 5 hours.

Amount of cis-atracurium usage during surgery

Group	Value	95% CI
Group NSS	0.08	± 0.02
Group Mg	0.08	± 0.01

Patient Received Intraoperative Packed Red Cell (PRC) Secondary · Intraoperative period from skin was incised to the skin was closure, an average 5 hours.

Number of patients who required Intraoperative PRC transfusion

Group	Value	95% CI
Group NSS	10
Group Mg	7

Adverse events — posted to ClinicalTrials.gov

Time frame: adverse event that occurred in the operating room until discharge from hospital, an average 8 days but maximum is 35 days. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Group NSS

Serious: 1/38 (3%)

Deaths: 0/38

Group Mg

Serious: 1/38 (3%)

Deaths: 0/38

Serious adverse events (1 terms)

Reaction	System	Group NSS	Group Mg
Severe brain edema	Nervous system disorders	—	—

Other adverse events (2 terms — click to expand)

Reaction	System	Group NSS	Group Mg
Minor neurological complication	Nervous system disorders	—	—
Infection	Infections and infestations	—	—

Most-reported serious reactions: Severe brain edema.

Data from ClinicalTrials.gov NCT03558516 adverse events section.

Sponsor's own description

Meningioma is the most common central nervous system tumor and craniotomy with tumor removal was associated with moderate blood loss and blood transfusion. Magnesium has hypotensive effect and probably reduce intraoperative blood loss. Whether or not magnesium sulphate can reduce intraoperative blood loss and improve postoperative cognitive function is still inconclusive. So the investigators conduct the randomized control trial to compare the effect of magnesium with placebo control in blood loss and cognitive function in meningioma patient undergoing craniotomy.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.