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Other Fusion of Spine, Cervical RegionNCT04161508

Enhanced Recovery After Surgery for Anterior Cervcial Spine Surgeries in Elderly Patients

A study testing Sugammadex Injection and Neostigmine Injection in people with Other Fusion of Spine, Cervical Region, run by Taipei Veterans General Hospital, Taiwan.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Elderly patients are subjected to airway and other complications after cervical spine surgeries. The study aim to investigate the efficacy of sugammadex (vs. neostigmine) in the recovery after anterior cervical spine surgery. Read more about this study

Who is it for?
Ages 65 to 85 years
Conditions the study is for
Other Fusion of Spine, Cervical Region
What is being tested?
Sugammadex Injection and Neostigmine Injection
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
No sites listed yet
Study dates
20 Dec 2019to 20 Dec 2022
Phase
Interventional
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 65 to 85 years
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • anterior cervical spine surgery American society of anesthesiologist (ASA) physical status I~III

Who cannot join

  • unstable cervical spine requiring immobilization orthosis previous allgery to rocurium, sugammadex, and neostigmine anticipated difficult tracheal intubation preoperative sorethroat, dysphoina or dysphagia history, regardless of etiology lack of informed consent
  • -

Trial locations and contacts

No sites are listed yet.

Ya-Chun Chu, MD, PhD contact

+886-2-287549 ext. 379

yachunchu@gmail.com

Wen-Cheng Huang, MD, PhD contact

+886-2-2875-7491

wchuang518@gmail.com

About this study

Official title: Enhanced Recovery After Surgery in Elderly Patients: Effects of Sugammadex on Recovery After Anterior Cervical Spine Surgery

Elderly patients are subjected to airway and other complications after cervical spine surgeries. The study aim to investigate the efficacy of sugammadex (vs. neostigmine) in the recovery after anterior cervical spine surgery.

Read the detailed description

Cervical spine surgeries have been increasing for many years. In Taiwan, according to the data published by the Department of Statistics, Ministry of the Interior, the elderly population (≥ 65 years old) increased and comprised 14.4% of the whole population in March, 2018. The percentages is likely to rise to 20% after 8 years. Because cervical spine surgery is a procedure commonly performed in elderly patients, the increasing trend of cervical spine surgery will likely continue. Elderly patients experienced an increased odds of length of stay ≥ 5 days, pulmonary complications, cardiac compilations, venous thromboembolism, UTI, sepsis, and unplanned readmission after anterior cervical spine surgeries according to the literature. For example, in patients ≥ 65 years old undergoing cervical spine surgery, 9.80% patients experienced at least 1 complication or death. Patients of 70~74 years old (odds ratio [OR] =1.94, 95% confidence interval [CI] = 1.03~3.65) and patients with at least 1 postoperative complication (OR 9.59, 95% CI 5.17~17.80) had increased risks of unplanned readmissions. Patients ≥ 75 years old were at higher risk of developing a complication or death with an odds ratio (OR 1.72, 95% CI 1.13~2.61). Identification of factors and change the policy of standard care in elderly patients can improve surgical outcome. The elderly have a different physiological change, such as lower elimination of the anesthetics, resulting in the confusion or delaying of detecting complications after the surgery.

Airway complications after ACCS are not uncommon. This includes sorethroat, vocal cord paresis without overt symptoms, vocal cord palsy or dysphonia, and dysphagia. The incidence of voice and swallowing complaints is primarily published in the spine literature and is inconsistent with rates ranging between 0.4% and 71%. The discrepancy may result from differences in the measurements and timepoints. We have performed a preliminary observational study investigating postoperative dysphonia and dysphagia after anterior cervical spine surgeries. We demonstrated more patients score none or mild dysphonia after surgeries in groups receiving sugammadex as a reversal of muscle relaxants. Suggammadex is a unique neuromuscular reversal drug; modified γ-cyclodextrin that allows binding encapsulation of rocuronium. The rocuronium molecule (a modified steroid) bound within sugammadex's lipophilic core, is rendered unavailable to bind to the acetylcholine receptor at the neuromuscular junction and results in the revesal of the effect of neuromuscular blackade. As the preliminary observation was not a randomized, blinded study, whether sugammadex posses beneficial effect on postoerative dysphonia warrants investigation.

Enhanced Recovery After Surgery (ERAS) proposes a multimodal, evidence-based approach to perioperative care. The first goal of ERAS is the improvement of surgical outcomes and patient experience, with a final impact on a reduction in the hospital length of stay (LOS). The implementation of ERAS in spinal surgery is in the early stages. We believe the elements for ERAS should direct to the specific characteristics of surgery and surgical population. Therefore, our investigation for improving posteropative dyshonia and dysphagia will provide a important reference for choice of elements for ERAS of cervical spine surgeries in the future.

Being tested
Sugammadex Injection, Neostigmine Injection
Keywords
sugammadex, anterior cervical spine surgery

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Sugammadex InjectionDrug

    injection of sugammadex for the reversal of neuromuscular blockade at the end of the surgery

  • Neostigmine InjectionDrug

    Also called glycopyrrolate

    injection of neostigmine for the reversal of neuromuscular blockade at the end of the surgery

Study groups in NCT04161508
Study groupRoleWhat they receive
SugammadexExperimentalsugammadex 2 mg/ Kg for the reversal of neuromuscular blockade at the end of surgery
Receives: Drug: Sugammadex Injection
NeostigmineActive comparatorneostigmine 50 mcg/Kg + glycopyrrolate 10 mcg/kg for the reversal of neuromuscular blockade at the end of surgery
Receives: Drug: Neostigmine Injection

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. mean time to 90% TOF ratio

    time from injection of drug to train of four ratio to 90%

    Measured: up to postoperative 2 hour

  2. mean time to extubation

    time from injection of drug to tracheal extubation

    Measured: up to postoperative 3 day

Secondary outcomes (3)
  1. postoperative sorethroat

    verbal numerical rating scale (0~10, 0 denotes no sorethroat; 10 denotes maximal sorethroat)

    Measured: postoperative Day 1, 2,3,7,10,30

  2. postoperative dysphonia

    subjective assessment of voice change in horaseness, pitch, and loudness(0, 1, 2; 0 denotes none or no change; 1 denotes mild change; 2 denotes obvious change)

    Measured: postoperative Day 1, 2,3,7,10,30

  3. postoperative dysphagia

    subjective assessment of dsyphagia by Bazaz classification (based on the easiness to swallow liquid or solid food, the severity is classified into none, mild, moderate and severe)

    Measured: postoperative Day 1, 2,3,7,10,30

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Nov 2019
  2. Study start20 Dec 2019 (estimated)
  3. Primary completion20 Dec 2021 (estimated)
  4. Study completion20 Dec 2022 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
Participants are randomly allocated into one of the two group: neostigmine and sugammadex group for reversal of neuromuscular blockade
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04161508
Sponsor's protocol ID
2019-06-003B
Status last verified
Nov 2019
First submitted
7 Nov 2019
Last updated
13 Nov 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Sugammadex Injection and Neostigmine Injection in people with Other Fusion of Spine, Cervical Region, run by Taipei Veterans General Hospital, Taiwan.

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 1 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 13 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.

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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Ya-Chun Chu, MD, PhD (+886-2-287549 ext. 379, yachunchu@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

mean time to 90% TOF ratio (time frame: up to postoperative 2 hour). The study lists 2 primary outcomes in all. 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 13 Nov 2019.

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