NCT04603638

Brief Summary

In this study ; Two randomized groups will be created. Iv magnesium will be given to one of the blindly designated groups. The other group will be given only isotonic. All patients will be awakened after the analgesic agents (0,1mg / kg morphine, 15mg / kg paracetamol, nsaid) are used in routine practice and will be followed up for intensive care. The use of PCA (patient controlled analgesia) device is available in both groups.In post-operative period, magnesium infusion will be continued for 12 h. Only 100cc isotonic will be given without using magnesium to the other group. VAS (visual analog scale) score will be recorded at postoperative 30. minutes and 2,6,12,18,24 hours. In routine administration, the patient should be given 2 mg of morphine if vas\>4 and the maximum dose will be increased to 10 mg.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
82

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 4, 2020

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

August 9, 2020

Completed
3 months until next milestone

First Posted

Study publicly available on registry

October 27, 2020

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 4, 2021

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 4, 2022

Completed
Last Updated

October 27, 2020

Status Verified

October 1, 2020

Enrollment Period

1.3 years

First QC Date

August 9, 2020

Last Update Submit

October 25, 2020

Conditions

AnalgesiaPostoperative Pain

Keywords

magnesiummorphinescoliosis

Outcome Measures

Primary Outcomes (2)

  • morphine consumption

    The analgesia methods will be compared with morphine consumption

    24 hours

  • VAS score

    The analgesia methods will be compared with VAS score

    24 hours

Study Arms (2)

magnesium

ACTIVE COMPARATOR

participations will be given intravenous magnesium.

Drug: Magnesium

control

PLACEBO COMPARATOR

participations will be given intravenous isotonic.

Drug: Isotonic

Interventions

MagnesiumDRUG

40 mg/kg(peroperative), 40 mg/kg (postoperative 12 h)

Also known as: NMDA (n-metil d aspartat) blocker
magnesium
IsotonicDRUG

100 ml

Also known as: Saline
control

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years old
  • Patients with posterior instrumentation surgery of 3 or more levels under general anesthesia with a cobb angle of 40 degrees and above
  • Patients who will be awakened after the surgery is completed and intensive care follow-up
  • Patients with ASA classification 1-3
  • Patients with creatine value \<1.3 g / dl

You may not qualify if:

  • Having a history of chronic neuropathic pain
  • Having a psychiatric illness
  • Patients who should not be awakened after surgery but should be followed up intubated and sedated
  • Patients who cannot provide adequate cooperation for scoring
  • Patients with chronic opioid use and / or substance use
  • Patients with ASA classification\> 3
  • Patients with a creatinine value of 1.3 g / dl and higher

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul University

Istanbul, 34093, Turkey (Türkiye)

RECRUITING

Related Publications (1)

  • Jabbour HJ, Naccache NM, Jawish RJ, Abou Zeid HA, Jabbour KB, Rabbaa-Khabbaz LG, Ghanem IB, Yazbeck PH. Ketamine and magnesium association reduces morphine consumption after scoliosis surgery: prospective randomised double-blind study. Acta Anaesthesiol Scand. 2014 May;58(5):572-9. doi: 10.1111/aas.12304. Epub 2014 Mar 17.

    PMID: 24635528BACKGROUND

MeSH Terms

Conditions

AgnosiaPain, PostoperativeScoliosis

Interventions

MagnesiumN-MethylaspartateSodium Chloride

Condition Hierarchy (Ancestors)

Perceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsPostoperative ComplicationsPathologic ProcessesPainSpinal CurvaturesSpinal DiseasesBone DiseasesMusculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Metals, Alkaline EarthElementsInorganic ChemicalsMetals, LightMetalsAspartic AcidAmino Acids, AcidicAmino AcidsAmino Acids, Peptides, and ProteinsAmino Acids, DicarboxylicChloridesHydrochloric AcidChlorine CompoundsSodium Compounds

Study Officials

  • Mehmet Ilke Buget

    Istanbul University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Dilek HUNDUR

CONTACT

+905367044679dilekhundur@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident at Anesthesiology and Reanimation

Study Record Dates

First Submitted

August 9, 2020

First Posted

October 27, 2020

Study Start

March 4, 2020

Primary Completion

July 4, 2021

Study Completion

February 4, 2022

Last Updated

October 27, 2020

Record last verified: 2020-10

Locations

TU(1)