NCT04716439

Brief Summary

Anesthesia for neurosurgery requires balancing deep and effective anesthesia as well as postoperative analgesia versus the risks of delayed recovery and postoperative respiratory depression. This randomized placebo-controlled, double-blind study was designed to evaluate the effect of magnesium sulfate on the total anesthetic and analgesic consumption using the clinical parameters in addition to the effect on IONM reading.

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
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2021

Shorter than P25 for all trials

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

First Submitted

Initial submission to the registry

January 11, 2021

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 20, 2021

Completed
12 days until next milestone

Study Start

First participant enrolled

February 1, 2021

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2021

Completed
Last Updated

January 22, 2021

Status Verified

January 1, 2021

Enrollment Period

7 months

First QC Date

January 11, 2021

Last Update Submit

January 19, 2021

Conditions

Spine Surgery

Outcome Measures

Primary Outcomes (1)

  • IONM Reading

    Reading the effect on the intraoperative neuromonitoring either motor or sensory evoked potential

    1- baseline 2-during surgery 3-immediately after surgery

Secondary Outcomes (4)

  • Blood Pressure

    1- baseline 2-during surgery 3-immediately after surgery 4- every one hour postoperative till 24 hours

  • Heart Rate

    1- baseline 2-during surgery 3-immediately after surgery 4- every one hour postoperative till 24 hours

  • Morphine Consumption

    Over 24 hours postoperative

  • Pain Score

    Over 24 hours postoperative

Study Arms (1)

magnesium sulfate effect on IONM reading in spine surgery

one group receives magnesium other do not

Procedure: Spine Surgery

Interventions

Spine SurgeryPROCEDURE

spine decompression and fixation

magnesium sulfate effect on IONM reading in spine surgery

Eligibility Criteria

Age30 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Adult ASA 1OR 2

You may qualify if:

  • Adult Patients Undergoing Spine Surgery

You may not qualify if:

  • Renal Impairment
  • Liver Cell failure
  • Heart Block

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Anesthesia Department, Faculty of Medicine, King Khalid University Hospital, King Saud University

Riyadh, Saudi Arabia

Location

Study Officials

  • ESSAM M MANAA, MD

    Assistant Professor and Consultant, Anesthesia Department, Faculty of Medicine, KKUH, KSU, Riyadh, Saudi Arabia

    PRINCIPAL INVESTIGATOR

Central Study Contacts

ESSAM M MANAA, MD

CONTACT

+966509870124e_manaa@yahoo.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Target Duration
8 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor & Consultant

Study Record Dates

First Submitted

January 11, 2021

First Posted

January 20, 2021

Study Start

February 1, 2021

Primary Completion

September 1, 2021

Study Completion

October 1, 2021

Last Updated

January 22, 2021

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will not share

Locations

SA(1)