Clinical trial NCT04161508: Enhanced Recovery After Surgery for Anterior Cervcial Spine Surgeries in Elderly Patients
Official title: Enhanced Recovery After Surgery in Elderly Patients: Effects of Sugammadex on Recovery After Anterior Cervical Spine Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Other Fusion of Spine, Cervical Region
Keywords: sugammadex, anterior cervical spine surgery
Lead sponsor: Taipei Veterans General Hospital, Taiwan
Sponsor class: OTHER_GOV
First posted: 2019-11-13
Enrollment: 100
Sex: ALL
Minimum age (years): 65
Maximum age (years): 85
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants are randomly allocated into one of the two group: neostigmine and sugammadex group for reversal of neuromuscular blockade
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

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Primary outcomes:
measure: mean time to 90% TOF ratio
timeFrame: up to postoperative 2 hour
measure: mean time to extubation
timeFrame: up to postoperative 3 day
Secondary outcomes:
measure: postoperative sorethroat
timeFrame: postoperative Day 1, 2,3,7,10,30
measure: postoperative dysphonia
timeFrame: postoperative Day 1, 2,3,7,10,30
measure: postoperative dysphagia
timeFrame: postoperative Day 1, 2,3,7,10,30
Other outcomes:
measure: postoperative muscle power
timeFrame: postoperative 2 hour, Day 1
measure: time to left off bed
timeFrame: up to postoperative 14 day
measure: time to remove foley catheter
timeFrame: up to postoperative 7 day
measure: complications
timeFrame: up to postoperative 14 day
measure: hospital day
timeFrame: up to postoperative 14 day
Locations:
Study officials:
affiliation: Taipei Veterans General Hospital, Taiwan
name: Ya-Chun Chu, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: