NCT03399890

Brief Summary

Neurological physical exam is a very important outcome that should be evaluated as soon as possible after every lumbar procedures. The aim of this study was to evaluate the neurological physical examination time after lumbar procedures.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
107

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2017

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

May 10, 2017

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 10, 2017

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 10, 2017

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 11, 2017

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 17, 2018

Completed
Last Updated

January 24, 2018

Status Verified

January 1, 2018

Enrollment Period

2 months

First QC Date

December 11, 2017

Last Update Submit

January 23, 2018

Conditions

Neurological Complication

Outcome Measures

Primary Outcomes (1)

  • Neurological physical examination time

    Neurological physical examination time

    postoperative first 30 minutes

Secondary Outcomes (1)

  • Muscle strength at PACU transfer

    postoperative first 60 minutes

Study Arms (2)

Group S

Group S: Group sugammadex Patients in this group received sugammadex at the end of the surgery, as neuromuscular reversal agent. Neurological physical exam time was recorded.

Diagnostic Test: Neurological physical exam

Group N

Group N: Group Neostigmine Patients in this group received neostigmine at the end of the surgeryas neuromuscular reversal agent. Neurological physical exam time was recorded.

Diagnostic Test: Neurological physical exam

Interventions

Neurological physical examDIAGNOSTIC_TEST

Neurological physical exam is performed in all patients at the OR table, immediately after the operation.

Group NGroup S

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All lumbar surgeries performed during the study period were enrolled in the study.

You may qualify if:

  • Lumber surgery
  • ASA I-II
  • Elective surgery

You may not qualify if:

  • Emergency cases
  • Age lower than 18
  • Age higher than 65
  • Patient with existing neurological deficit
  • Patient with existing renal insufficiency

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ankara University Faculty of Medicine

Ankara, Turkey (Türkiye)

Location

Study Officials

  • Basak Ceyda MECO, MD

    Ankara University Faculty of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Prof.

Study Record Dates

First Submitted

December 11, 2017

First Posted

January 17, 2018

Study Start

May 10, 2017

Primary Completion

July 10, 2017

Study Completion

October 10, 2017

Last Updated

January 24, 2018

Record last verified: 2018-01

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)