Influence of Shared-Decision Making in Reducing Decision Conflict on the Choice of Awakening Agent After General Anesthesia

Influence of Shared-Decision Making in Reducing Decision Conflict on the Choice of Awakening Agent After General Anesthesia: A Multicenter Randomized Controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Decision Making, Shared
• Intervention / Treatment: Other: Shared decision making with the used of patient decision aids

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 3309
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • New Taipei City, Taiwan, 23561
    • Shuang Ho Hospital, Taipei Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Patients who receive general anesthesia
2. Adults older than 20 years
3. Communicable with Mandarin
4. Patients who receive anesthesia consulting

Exclusion Criteria:

1. Patients who do not receive general anesthesia
2. Patients receive spinal anesthesia
3. Not communicable with Mandarin.
4. Emergency patient who do not receive anesthesia consulting

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SDM group; Shared decision making using PDAs. PDAs is used as a tool explain the advantages and disadvantages of 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.	Other: Shared decision making with the used of patient decision aids; PDA is used to explain choices of reversal drugs using SDM approach during consultation. The patients and medical staff explore the preferences with PDA and make decision together.
No Intervention: Control group; Current approach to explain details of anesthesia using a single introductory sheet made by the two hospitals or provided by the pharmaceutical companies is used.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Decision conflicts	Mean score of decisional conflict scale by SURE test (developed by Ottawa University) using a five-item scale: 1. disagree strongly; 2. disagree; 3. neutral; 4. agree; 5. agree strongly.	One day after surgery
Knowledge	Mean score of understanding of reversal drugs by SURE test (developed by Ottawa University) using a five-item scale: 1. disagree strongly; 2. disagree; 3. neutral; 4. agree; 5. agree strongly.	One day after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of choices of reversal drugs	Percentage of choices of reversal drugs	10 minutes before anesthesia

Collaborators and Investigators

• Sponsor: Taipei Medical University Shuang Ho Hospital
• Collaborators: Chi Mei Medical Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 20, 2020
• Primary Completion (Actual): August 20, 2020
• Study Completion (Actual): September 20, 2020

Study Registration Dates

• First Submitted: February 13, 2020
• First Submitted That Met QC Criteria: February 13, 2020
• First Posted (Actual): February 17, 2020

Study Record Updates

• Last Update Posted (Actual): March 19, 2021
• Last Update Submitted That Met QC Criteria: March 18, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: shared decision making, sugammadex, patient decision aids
• Other Study ID Numbers: N201909073; 10812-015 (Other Identifier: Chi Mei Medical Center)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes

Drug and device information, study documents

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