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

NCT04272177 | Completed DMC

• 2 other identifiers: N20190907310812-015
• Study Type: interventional
• Target: 3,309
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Decision Making, Shared

Keywords

shared decision making, sugammadex, patient decision aids

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Percentage of choices of reversal drugs

  10 minutes before anesthesia

Study Arms (2)

SDM group

EXPERIMENTAL

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

Control group

NO INTERVENTION

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.

Interventions

Shared decision making with the used of patient decision aids OTHER

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.

SDM group

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who receive general anesthesia
• Adults older than 20 years
• Communicable with Mandarin
• Patients who receive anesthesia consulting

You may not qualify if:

• Patients who do not receive general anesthesia
• Patients receive spinal anesthesia
• Not communicable with Mandarin.
• Emergency patient who do not receive anesthesia consulting

Sponsors & Collaborators

• Taipei Medical University Shuang Ho Hospital: lead
• Chi Mei Medical Hospital: collaborator

Study Sites (1)

Shuang Ho Hospital, Taipei Medical University

New Taipei City, 23561, Taiwan

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Shared Decision Making Resource Center

Study Record Dates

• First Submitted: February 13, 2020
• First Posted: February 17, 2020
• Study Start: March 20, 2020
• Primary Completion: August 20, 2020
• Study Completion: September 20, 2020
• Last Updated: March 19, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will share

Locations

TW (1)