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

NCT ID: NCT04161508

Last Updated: 2019-11-13

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-12-20
• Study Completion Date: 2022-12-20

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.

Conditions

Other Fusion of Spine, Cervical Region

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Sugammadex

sugammadex 2 mg/ Kg for the reversal of neuromuscular blockade at the end of surgery

Group Type: EXPERIMENTAL

Sugammadex Injection

Intervention Type: DRUG

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

Neostigmine

neostigmine 50 mcg/Kg + glycopyrrolate 10 mcg/kg for the reversal of neuromuscular blockade at the end of surgery

Group Type: ACTIVE_COMPARATOR

Neostigmine Injection

Intervention Type: DRUG

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

Interventions

Sugammadex Injection

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

Intervention Type: DRUG

Neostigmine Injection

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

Intervention Type: DRUG

Other Intervention Names

glycopyrrolate

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

-

• Minimum Eligible Age: 65 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Taipei Veterans General Hospital, Taiwan

OTHER_GOV

Sponsor Role: lead

Responsible Party

vghtpe user

Ya-Chun Chu, MD, PhD, Chief of Division of Neuroanesthesia, department of Anesthesiology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ya-Chun Chu, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Taipei Veterans General Hospital, Taiwan

Central Contacts

Ya-Chun Chu, MD, PhD

Role: CONTACT

yachunchu@gmail.com

+886-2-287549 ext. 379

Wen-Cheng Huang, MD, PhD

Role: CONTACT

wchuang518@gmail.com

+886-2-2875-7491

Other Identifiers

2019-06-003B

Identifier Type: -

Identifier Source: org_study_id