Clinical trial NCT06609538: The Impact of Preoperative Suggestion on Dreaming
Official title: The Impact of Preoperative Suggestions on Dreaming With Intravenous Sedation: A Randomized Controlled, Blinded Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dream, Day
Ketamine Adverse Reaction
Propofol Adverse Reaction
Keywords: Suggestion
dream incidence
dream contents
emotional tone
patient satisfaction
Lead sponsor: Wonkwang University Hospital
Sponsor class: OTHER
First posted: 2024-09-24
Enrollment: 250
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: 1. Control Group with Propofol: Receives standard preoperative instructions and propofol infusion.
2. Suggestion Group with Propofol: Receives positive preoperative suggestions and propofol infusion.
3. Control Group with Ketamine: Receives standard preoperative instructions and ketamine infusion.
4. Suggestion Group with Ketamine: Receives positive preoperative suggestions and ketamine infusion.
Primary purpose: SUPPORTIVE_CARE

Brief summary: Recent studies have shown that positive preoperative suggestions can significantly influence the quality of dreams and reduce the incidence of unpleasant dreams during sedation with agents like ketamine and propofol.

Detailed description: Cheong et al. demonstrated that a simple positive suggestion before ketamine administration could reduce unpleasant dreams, while Kim et al. found that propofol, compared to midazolam, led to more vivid and memorable dreams, along with similar satisfaction levels in patients. This study aims to extend these findings by comparing the effects of propofol and ketamine sedation on dreaming during anesthesia, with a focus on how preoperative suggestions might influence dream content, emotional tone, and patient satisfaction.

Eligibility criteria: Inclusion Criteria:

* Adult patients aged 20-65 years.
* ASA physical status I-III.
* Scheduled for elective spinal anesthesia or brachial plexus block.
* Fluent in Korean.

Exclusion Criteria:

* Use of any medication, including premedication, within 12 hours before surgery.
* Cognitive impairments or psychiatric disorders (including a history of unpleasant dreams or nightmares).
* Current use of sedatives or hypnotics.
* History of severe or recurrent nightmares.

Primary outcomes:
measure: Incidence of Dreaming
timeFrame: Dreaming will be assessed immediately after full awakeness in the Post-Anesthesia Care Unit (PACU).
measure: Quality of Dreaming
timeFrame: Dreaming will be assessed immediately in the Post-Anesthesia Care Unit (PACU).
Secondary outcomes:
measure: Satisfaction with Care
timeFrame: Satisfaction will be assessed immediately after full awakeness in the Post-Anesthesia Care Unit (PACU)
measure: Adverse events
timeFrame: Monitoring will be continuous with regular vital signs recorded every 5 minutes during surgery and every 15 minutes in the PACU.
Other outcomes:
Locations:
city: Iksan
country: Korea, Republic of
facility: WonwangUH
state: Please Select
Study officials:
affiliation: Wonkwang University Hospital
name: Cheol Lee, M.D.,Ph.D
role: STUDY_DIRECTOR
References: