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

Other Fusion of Spine, Cervical Region Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04161508
• Other study ID #: 2019-06-003B
• Status: Not yet recruiting
• Phase: N/A
• Start date: December 20, 2019
• Est. completion date: December 20, 2022

Study information

• Verified date: November 2019
• Source: Taipei Veterans General Hospital, Taiwan
• Contact: Ya-Chun Chu, MD, PhD
• Phone: +886-2-287549
• Email: yachunchu[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: December 20, 2022
• Est. primary completion date: December 20, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years to 85 Years

Eligibility

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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Related Conditions & MeSH terms

• Other Fusion of Spine, Cervical Region

Intervention

Drug:
• Sugammadex Injection
injection of sugammadex for the reversal of neuromuscular blockade at the end of the surgery
• Neostigmine Injection
injection of neostigmine for the reversal of neuromuscular blockade at the end of the surgery

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Taipei Veterans General Hospital, Taiwan

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	postoperative muscle power	the grading of muscle power (MRC):0~5, 0 denotes complete paralysis, 5 denote normal power	postoperative 2 hour, Day 1
Other	time to left off bed	time to patient can left off from bed	up to postoperative 14 day
Other	time to remove foley catheter	time to the foley catheter can be removed from patient	up to postoperative 7 day
Other	complications	any occurrence of global, respiratory and cardiovascular adverse events	up to postoperative 14 day
Other	hospital day	total day that patients are kept in the hospital	up to postoperative 14 day
Primary	mean time to 90% TOF ratio	time from injection of drug to train of four ratio to 90%	up to postoperative 2 hour
Primary	mean time to extubation	time from injection of drug to tracheal extubation	up to postoperative 3 day
Secondary	postoperative sorethroat	verbal numerical rating scale (0~10, 0 denotes no sorethroat; 10 denotes maximal sorethroat)	postoperative Day 1, 2,3,7,10,30
Secondary	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)	postoperative Day 1, 2,3,7,10,30
Secondary	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)	postoperative Day 1, 2,3,7,10,30