The Influence of Neuromuscular Reversal on Neurological Physical Exam Time in Lumbar Neurosurgical Cases.

January 23, 2018 updated by: Basak Ceyda MECO, Ankara University

The Influence of Neuromuscular Reversal With Neostigmine or Sugammadex on Neurological Physical Exam Time in Lumbar Neurosurgical Cases.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Neurological physical exam is a very important outcome that should be evaluated as soon as possible after every lumbar procedures. By that early postoperative neurological complications can be revealed and early interventions planned. The aim of this study was to evaluate the neurological physical examination time after lumbar procedures. Two routinely used different reversal agents (neostigmine or sugammadex) were compared according reversal times and muscle strength on PACU admission.

Study Type

Observational

Enrollment (Actual)

107

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Ankara, Turkey
        • Ankara University Faculty of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

  • Lumber surgery
  • ASA I-II
  • Elective surgery

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
Neurological physical exam is performed in all patients at the OR table, immediately after the operation.
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
Neurological physical exam is performed in all patients at the OR table, immediately after the operation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Neurological physical examination time
Time Frame: postoperative first 30 minutes
Neurological physical examination time
postoperative first 30 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Muscle strength at PACU transfer
Time Frame: postoperative first 60 minutes
Muscle strength at PACU transfer (evaluated with a 5 point scale) 0/5: no contraction in muscles 1/5: muscle flicker but no movement 2/5: movement possible bıt not against gravity (test the joint in its horizontal plane) 3/5: moment possible against gravity but not against resistance by the examiner 4/5: movement possible against resistance by the examiner 5/5: normal strength
postoperative first 60 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ankara University

Investigators

  • Principal Investigator: Basak Ceyda MECO, MD, Ankara University Faculty of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

May 10, 2017

Primary Completion (ACTUAL)

July 10, 2017

Study Completion (ACTUAL)

October 10, 2017

Study Registration Dates

First Submitted

December 11, 2017

First Submitted That Met QC Criteria

January 8, 2018

First Posted (ACTUAL)

January 17, 2018

Study Record Updates

Last Update Posted (ACTUAL)

January 24, 2018

Last Update Submitted That Met QC Criteria

January 23, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

  • 10-544

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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