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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04161508
Enrollment
100
Registered
2019-11-13
Start date
2019-12-20
Completion date
2022-12-20
Last updated
2019-11-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Other Fusion of Spine, Cervical Region

Keywords

sugammadex, anterior cervical spine surgery

Brief 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.

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.

Interventions

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

DRUGNeostigmine Injection

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

Sponsors

Taipei Veterans General Hospital, Taiwan
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)

Masking description

Randomization and drug preparation are executed by a nurse anesthetist according to the body weight of the patients. The nurse anesthetist is not responsible for perioperative anesthetic care, and outcome assessemnt. The volume of drugs is adjusted to 10 ml with addition of normal saline to become undifferent in appearance

Intervention model description

Participants are randomly allocated into one of the two group: neostigmine and sugammadex group for reversal of neuromuscular blockade

Eligibility

Sex/Gender
ALL
Age
65 Years to 85 Years
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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 \-

Design outcomes

Primary

MeasureTime frameDescription
mean time to 90% TOF ratioup to postoperative 2 hourtime from injection of drug to train of four ratio to 90%
mean time to extubationup to postoperative 3 daytime from injection of drug to tracheal extubation

Secondary

MeasureTime frameDescription
postoperative sorethroatpostoperative Day 1, 2,3,7,10,30verbal numerical rating scale (0\ 10, 0 denotes no sorethroat; 10 denotes maximal sorethroat)
postoperative dysphoniapostoperative Day 1, 2,3,7,10,30subjective 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)
postoperative dysphagiapostoperative Day 1, 2,3,7,10,30subjective 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)

Other

MeasureTime frameDescription
postoperative muscle powerpostoperative 2 hour, Day 1the grading of muscle power (MRC):0\ 5, 0 denotes complete paralysis, 5 denote normal power
time to remove foley catheterup to postoperative 7 daytime to the foley catheter can be removed from patient
time to left off bedup to postoperative 14 daytime to patient can left off from bed
complicationsup to postoperative 14 dayany occurrence of global, respiratory and cardiovascular adverse events
hospital dayup to postoperative 14 daytotal day that patients are kept in the hospital

Contacts

Primary ContactYa-Chun Chu, MD, PhD
yachunchu@gmail.com+886-2-287549
Backup ContactWen-Cheng Huang, MD, PhD
wchuang518@gmail.com+886-2-2875-7491

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026