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

NCT04161508 | Unknown

• 1 other identifier: 2019-06-003B
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Other Fusion of Spine, Cervical Region

Keywords

sugammadex, anterior cervical spine surgery

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• postoperative sorethroat

  postoperative Day 1, 2,3,7,10,30

• postoperative dysphonia

  postoperative Day 1, 2,3,7,10,30

• postoperative dysphagia

  postoperative Day 1, 2,3,7,10,30

Other Outcomes (5)

• postoperative muscle power

  postoperative 2 hour, Day 1

• time to left off bed

  up to postoperative 14 day

• time to remove foley catheter

  up to postoperative 7 day

Study Arms (2)

Sugammadex

EXPERIMENTAL

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

Drug: Sugammadex Injection

Neostigmine

ACTIVE COMPARATOR

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

Drug: Neostigmine Injection

Interventions

Sugammadex Injection DRUG

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

Sugammadex

Neostigmine Injection DRUG

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

Also known as: glycopyrrolate

Neostigmine

Eligibility Criteria

• Age: 65 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Taipei Veterans General Hospital, Taiwan: lead

MeSH Terms

Interventions

Sugammadex; Neostigmine; Glycopyrrolate

Intervention Hierarchy (Ancestors)

gamma-Cyclodextrins; Cyclodextrins; Macrocyclic Compounds; Polycyclic Compounds; Dextrins; Starch; Glucans; Polysaccharides; Carbohydrates; Phenylammonium Compounds; Quaternary Ammonium Compounds; Amines; Organic Chemicals; Onium Compounds; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Ya-Chun Chu, MD, PhD

  Taipei Veterans General Hospital, Taiwan

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ya-Chun Chu, MD, PhD

CONTACT

+886-2-287549; yachunchu@gmail.com

Wen-Cheng Huang, MD, PhD

CONTACT

+886-2-2875-7491; wchuang518@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ya-Chun Chu, MD, PhD, Chief of Division of Neuroanesthesia, department of Anesthesiology

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

Study Record Dates

• First Submitted: November 7, 2019
• First Posted: November 13, 2019
• Study Start: December 20, 2019
• Primary Completion: December 20, 2021
• Study Completion: December 20, 2022
• Last Updated: November 13, 2019

Record last verified: 2019-11