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

• Sponsor: Ankara University (Other)
• Overall Status: Completed
• CT.gov ID: NCT03399890
• Collaborator: (none)
• Enrollment: 107
• Location: 1
• Actual Duration (Months): 5
• Patients Per Site Per Month: 21.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Neurological Complication	Diagnostic Test: Neurological physical exam

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 Design

• Study Type: Observational
• Actual Enrollment: 107 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: The Influence of Neuromuscular Reversal With Neostigmine or Sugammadex on Neurological Physical Exam Time in Lumbar Neurosurgical Cases.
• Actual Study Start Date: May 10, 2017
• Actual Primary Completion Date: Jul 10, 2017
• Actual Study Completion Date: Oct 10, 2017

Arms and Interventions

Arm	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.

Outcome Measures

Primary Outcome Measures

1. Neurological physical examination time [postoperative first 30 minutes]

   Neurological physical examination time

Secondary Outcome Measures

1. Muscle strength at PACU transfer [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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ankara University Faculty of Medicine	Ankara		Turkey

Sponsors and Collaborators

• Ankara University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Basak Ceyda MECO, Associate Prof., Ankara University
• ClinicalTrials.gov Identifier: NCT03399890
• Other Study ID Numbers: 10-544
• First Posted: Jan 17, 2018
• Last Update Posted: Jan 24, 2018
• Last Verified: Jan 1, 2018

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Jan 24, 2018