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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Other Fusion of Spine, Cervical Region
• Intervention / Treatment: Drug: Sugammadex Injection; Drug: Neostigmine Injection

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.

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ya-Chun Chu, MD, PhD; Phone Number: 379 +886-2-287549; Email: yachunchu@gmail.com
• Study Contact Backup: Name: Wen-Cheng Huang, MD, PhD; Phone Number: +886-2-2875-7491; Email: wchuang518@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years to 85 years (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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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Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sugammadex; sugammadex 2 mg/ Kg for the reversal of neuromuscular blockade at the end of surgery	Drug: Sugammadex Injection; injection of sugammadex for the reversal of neuromuscular blockade at the end of the surgery
Active Comparator: Neostigmine; neostigmine 50 mcg/Kg + glycopyrrolate 10 mcg/kg for the reversal of neuromuscular blockade at the end of surgery	Drug: Neostigmine Injection; injection of neostigmine for the reversal of neuromuscular blockade at the end of the surgery; Other Names: glycopyrrolate

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
mean time to 90% TOF ratio	time from injection of drug to train of four ratio to 90%	up to postoperative 2 hour
mean time to extubation	time from injection of drug to tracheal extubation	up to postoperative 3 day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
postoperative sorethroat	verbal numerical rating scale (0~10, 0 denotes no sorethroat; 10 denotes maximal sorethroat)	postoperative Day 1, 2,3,7,10,30
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
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
postoperative muscle power	the grading of muscle power (MRC):0~5, 0 denotes complete paralysis, 5 denote normal power	postoperative 2 hour, Day 1
time to left off bed	time to patient can left off from bed	up to postoperative 14 day
time to remove foley catheter	time to the foley catheter can be removed from patient	up to postoperative 7 day
complications	any occurrence of global, respiratory and cardiovascular adverse events	up to postoperative 14 day
hospital day	total day that patients are kept in the hospital	up to postoperative 14 day

Collaborators and Investigators

• Sponsor: Taipei Veterans General Hospital, Taiwan
• Investigators: Principal Investigator: Ya-Chun Chu, MD, PhD, Taipei Veterans General Hospital, Taiwan

Study record dates

Study Major Dates

• Study Start (Anticipated): December 20, 2019
• Primary Completion (Anticipated): December 20, 2021
• Study Completion (Anticipated): December 20, 2022

Study Registration Dates

• First Submitted: November 7, 2019
• First Submitted That Met QC Criteria: November 9, 2019
• First Posted (Actual): November 13, 2019

Study Record Updates

• Last Update Posted (Actual): November 13, 2019
• Last Update Submitted That Met QC Criteria: November 9, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Keywords: sugammadex, anterior cervical spine surgery
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Muscarinic Antagonists; Cholinergic Antagonists; Cholinergic Agents; Enzyme Inhibitors; Adjuvants, Anesthesia; Cholinesterase Inhibitors; Parasympathomimetics; Glycopyrrolate; Neostigmine
• Other Study ID Numbers: 2019-06-003B

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No