- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06609538
The Impact of Preoperative Suggestion on Dreaming
February 22, 2025 updated by: Cheol Lee,MD,PhD,, Wonkwang University Hospital
The Impact of Preoperative Suggestions on Dreaming With Intravenous Sedation: A Randomized Controlled, Blinded Trial.
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.
Study Overview
Status
Completed
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
250
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Please Select
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Iksan, Please Select, Korea, Republic of, 54538
- WonwangUH
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Control Group with Propofol
Receives standard preoperative instructions and propofol infusion.
|
Receives standard preoperative instructions and propofol or ketamine infusion.
Other Names:
|
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Experimental: Suggestion Group with Propofol
Receives positive preoperative suggestions and propofol infusion.
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Receives positive preoperative suggestions and propofol or ketamine infusion.
Other Names:
|
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Active Comparator: Control Group with Ketamine
Receives standard preoperative instructions and ketamine infusion.
|
Receives standard preoperative instructions and propofol or ketamine infusion.
Other Names:
|
|
Experimental: Suggestion Group with Ketamine
Receives positive preoperative suggestions and ketamine infusion.
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Receives positive preoperative suggestions and propofol or ketamine infusion.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Incidence of Dreaming
Time Frame: Dreaming will be assessed immediately after full awakeness in the Post-Anesthesia Care Unit (PACU).
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The "Dreaming and Cognition Evaluation Questionnaire" will be used.questionnaire
evaluates the incidence of dreaming, as well as the dream's content, emotional tone (rated on a 1-5 scale from very unpleasant to very pleasant), memorability, visual vividness, intensity, and other qualitative aspects such as sound, movement, and emotional significance.
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Dreaming will be assessed immediately after full awakeness in the Post-Anesthesia Care Unit (PACU).
|
|
Quality of Dreaming
Time Frame: Dreaming will be assessed immediately in the Post-Anesthesia Care Unit (PACU).
|
The "Dreaming and Cognition Evaluation Questionnaire" will be used.
This questionnaire evaluates the incidence of dreaming, as well as the dream's content, emotional tone (rated on a 1-5 scale from very unpleasant to very pleasant), memorability, visual vividness, intensity, and other qualitative aspects such as sound, movement, and emotional significance.
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Dreaming will be assessed immediately in the Post-Anesthesia Care Unit (PACU).
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Satisfaction with Care
Time Frame: Satisfaction will be assessed immediately after full awakeness in the Post-Anesthesia Care Unit (PACU)
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A 101-point numerical rating scale included in the "Dreaming and Cognition Evaluation Questionnaire" will be used to measure patient satisfaction with the overall care and sedation experience.
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Satisfaction will be assessed immediately after full awakeness in the Post-Anesthesia Care Unit (PACU)
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Adverse events
Time Frame: Monitoring will be continuous with regular vital signs recorded every 5 minutes during surgery and every 15 minutes in the PACU.
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Any complications such as hypotension,or bradycardia, will be recorded systematically.
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Monitoring will be continuous with regular vital signs recorded every 5 minutes during surgery and every 15 minutes in the PACU.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Cheol Lee, M.D.,Ph.D, Wonkwang University Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 19, 2024
Primary Completion (Actual)
November 25, 2024
Study Completion (Actual)
January 30, 2025
Study Registration Dates
First Submitted
September 22, 2024
First Submitted That Met QC Criteria
September 22, 2024
First Posted (Actual)
September 24, 2024
Study Record Updates
Last Update Posted (Actual)
March 25, 2025
Last Update Submitted That Met QC Criteria
February 22, 2025
Last Verified
February 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Peripheral Nervous System Agents
- Anesthetics
- Central Nervous System Depressants
- Sensory System Agents
- Analgesics
- Neurotransmitter Agents
- Hypnotics and Sedatives
- Anesthetics, Intravenous
- Anesthetics, General
- Excitatory Amino Acid Agents
- Anesthetics, Dissociative
- Excitatory Amino Acid Antagonists
- Propofol
- Ketamine
Other Study ID Numbers
- Wonkwang UH15
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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