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

Neurological Complication Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03399890
• Other study ID #: 10-544
• Status: Completed
• Phase: N/A
• First received: December 11, 2017
• Last updated: January 23, 2018
• Start date: May 10, 2017
• Est. completion date: October 10, 2017

Study information

• Verified date: January 2018
• Source: Ankara University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 107
• Est. completion date: October 10, 2017
• Est. primary completion date: July 10, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Neurological Complication

Intervention

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

Locations

Country	Name	City	State
Turkey	Ankara University Faculty of Medicine	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Ankara University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Neurological physical examination time	Neurological physical examination time	postoperative first 30 minutes
Secondary	Muscle strength at PACU transfer	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 bit 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