Influence of Shared-Decision Making in Reducing Decision Conflict on the Choice of Awakening Agent After General Anesthesia
Condition: Decision Making, Shared
Study type: Interventional

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.
    

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.
    

Intervention name(s): Shared decision making with the used of patient decision aids
Intervention type(s): Other
Intervention description(s): 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Health Services Research
Keywords: shared decision making, sugammadex, patient decision aids