Neurological ComplicationNCT03399890
The Influence of Neuromuscular Reversal on Neurological Physical Exam Time in Lumbar Neurosurgical Cases.
An observational study of Neurological Complication, run by Ankara University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Neurological Complication
- What is being tested?
- Neurological physical exam
- How many people
- 107 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 May 2017to 10 Oct 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All lumbar surgeries performed during the study period were enrolled in the study.
Who may be able to join
- Lumber surgery
- ASA I-II
- Elective surgery
Who cannot join
- Emergency cases
- Age lower than 18
- Age higher than 65
- Patient with existing neurological deficit
- Patient with existing renal insufficiency
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Neurological Complication
- Being tested
- Neurological physical exam
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neurological physical examDiagnostic test
Neurological physical exam is performed in all patients at the OR table, immediately after the operation.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Diagnostic Test: Neurological physical exam |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neurological physical examination time
Neurological physical examination time
Measured: postoperative first 30 minutes
Secondary outcomes (1)
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 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
Measured: postoperative first 60 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2018
- Study start10 May 2017
- Primary completion10 Jul 2017
- Study completion10 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neurological ComplicationStudies of the same condition, open and under way.
- More trials run by Ankara UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 107 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Basak Ceyda MECO, Ankara University
- Investigators
- Basak Ceyda MECO, MD, Principal investigator, Ankara University Faculty of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03399890
- Sponsor's protocol ID
- 10-544
- Status last verified
- Jan 2018
- First submitted
- 11 Dec 2017
- Last updated
- 24 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Neuromuscular Reversal With Neostigmine or Sugammadex on Neurological Physical Exam Time in Lumbar Neurosurgical Cases.
- ClinicalTrials.gov ID
- NCT03399890
- Acronym / sponsor ID
- 10-544
- Conditions
- Neurological Complication
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 107 participants (actual)
- Lead sponsor
- Ankara UniversityUniversity, hospital or other
- Study start
- 10 May 2017 (actual)
- Primary completion
- 10 Jul 2017 (actual)
- Study completion
- 10 Oct 2017 (actual)
- First posted
- 17 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group S | – | Diagnostic Test: Neurological physical examGroup 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. |
| Group N | – | Diagnostic Test: Neurological physical examGroup N: Group Neostigmine Patients in this group received neostigmine at the end of the surgeryas neuromuscular reversal agent. Neurological physical exam time was recorded. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All lumbar surgeries performed during the study period were enrolled in the study.
Key inclusion criteria (3 listed)
- Lumber surgery
- ASA I-II
- Elective surgery
Key exclusion criteria (5 listed)
- Emergency cases
- Age lower than 18
- Age higher than 65
- Patient with existing neurological deficit
- Patient with existing renal insufficiency
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neurological physical examNeurological physical exam is performed in all patients at the OR table, immediately after the operation. | Diagnostic test | Group N, Group S |
Primary outcome
Neurological physical examination time
Time frame: postoperative first 30 minutes
Neurological physical examination time
1 secondary outcome
Muscle strength at PACU transfer
Time frame: postoperative first 60 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2018.
- Individual participant dataSharing planned: No
Related trials for Neurological Complication
RecruitingPhase 4
ESP Blocks for Posterior Spinal Fusion
Postoperative Pain
Recruiting
Effect of Cryotherapeutic and Nanotherapeutic Sodium Hypochlorite on Post-Operative Endodontic Pain.
Symptomatic Irreversible Pulpitis, Symptomatic Apical Periodontitis
RecruitingPhase 2
REctus Sheath Trial
Acute Pain, Postoperative Pain, Acute
Not yet recruiting
Effect of Pectoral Nerve Block (PECS) Using Magnesium Sulfate Added to Dexamethasone on Quality of Recovery and Chronic Post-Mastectomy Pain
Breast Cancer, Postoperative Pain
RecruitingObservational study
The Impact of Fast-Track Anesthesia on Postoperative Neurocognitive Function in Patients Undergoing Cardiac Surgery
Delirium - Postoperative, Cardiac Surgery
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Basak Ceyda MECO, MD principal investigator
Ankara University Faculty of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neurological Complication, run by Ankara University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neurological physical examination time (time frame: postoperative first 30 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jan 2018.