Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04272177 |
| Other study ID # |
N201909073 |
| Secondary ID |
10812-015 |
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
March 20, 2020 |
| Est. completion date |
September 20, 2020 |
Study information
| Verified date |
March 2021 |
| Source |
Taipei Medical University Shuang Ho Hospital |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
General anesthesia is an important procedure for patients undergoing a surgery. When
awakening is required after the surgery, the supply of anesthetic gas is terminated together
with the administration of reversal drugs. Acetylcholinesterase inhibitors were the main
drugs of choice in the past, most of the patients will awake in 15 to 30 minutes. The
breathing circuit will then be extracted when patient breathing has recovered to normal.
sugammadex, a new generation reversal drug, is a type of selective relaxant-binding agent
which recover patient muscle and breathing activities at around 3 minutes. In comparison with
neostigmine, sugammadex has a shorter awakening time and lower risk of bradycardia,
postoperative nausea vomiting, and postoperative residual paralysis. However, the drug has
not been widely applied in Taiwan because it is not covered by the national insurance. We
believe it would the patients to understand the characteristics of sugammadex in fair
perspectives and increase the operation power of surgical rooms if shared decision making
with the use of Patient Decision Aids (PDAs) is used during anesthesia consultation.
Description:
Background:
A PDA was developed to be administered during anethesia consultation for surgical patients.
We expect the PDA would benefit the intervention group in the aspects of knowledge and
communication in choosing reversal drugs.The aim of this study is to conduct a multicenter
randomized controlled trial (RCT) to evaluate the benefit of PDAs on decision making.
Patients and Methods:
Decision aids are interventions designed to help surgical patients with general anethesia to
choose their options of neostigmine or sugammadex by providing information on those options.
In this multicenter RCT, surgical patients are randomly divided into SDM and control groups.
In control group, patients will receive details of anesthesia using single introductory
sheet. In SDM group, PDA will be used as a tool to explain the benefits and harms between the
traditional reversal drugs and sugammadex. And by following SDM principles, the patients are
guided to consider their individual values and preferences and helped to make a choice that
best meet their needs. This study will be conducted in 2 hospitals (Shuang Ho Hospital and
Chi Mei Medical Center). The outcomes are decision conflicts and decision-making difficulties
after consultation of the patients.
Hypothesis:
The patients of the SDM group are predicted to have lower decisional conflict scores and
higher knowledge scores when compared with controlled group. Our study hopes to support the
efficacy of PDAs in helping surgical patients to make a choice that best meet their needs.
