NCT06609538

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
250

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 19, 2024

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

September 22, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 24, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 25, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2025

Completed
Last Updated

February 25, 2025

Status Verified

February 1, 2025

Enrollment Period

2 months

First QC Date

September 22, 2024

Last Update Submit

February 22, 2025

Conditions

Keywords

Suggestiondream incidencedream contentsemotional tonepatient satisfaction

Outcome Measures

Primary Outcomes (2)

  • Incidence of Dreaming

    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.

    Dreaming will be assessed immediately after full awakeness in the Post-Anesthesia Care Unit (PACU).

  • Quality of Dreaming

    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.

    Dreaming will be assessed immediately in the Post-Anesthesia Care Unit (PACU).

Secondary Outcomes (2)

  • Satisfaction with Care

    Satisfaction will be assessed immediately after full awakeness in the Post-Anesthesia Care Unit (PACU)

  • Adverse events

    Monitoring will be continuous with regular vital signs recorded every 5 minutes during surgery and every 15 minutes in the PACU.

Study Arms (4)

Control Group with Propofol

ACTIVE COMPARATOR

Receives standard preoperative instructions and propofol infusion.

Other: Control Group

Suggestion Group with Propofol

EXPERIMENTAL

Receives positive preoperative suggestions and propofol infusion.

Other: Suggestion Group

Control Group with Ketamine

ACTIVE COMPARATOR

Receives standard preoperative instructions and ketamine infusion.

Other: Control Group

Suggestion Group with Ketamine

EXPERIMENTAL

Receives positive preoperative suggestions and ketamine infusion.

Other: Suggestion Group

Interventions

Receives standard preoperative instructions and propofol or ketamine infusion.

Also known as: Propofol, Ketamine
Control Group with KetamineControl Group with Propofol

Receives positive preoperative suggestions and propofol or ketamine infusion.

Also known as: Propofol, Ketamine
Suggestion Group with KetamineSuggestion Group with Propofol

Eligibility Criteria

Age20 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

WonwangUH

Iksan, Please Select, 54538, South Korea

Location

MeSH Terms

Conditions

Patient Satisfaction

Interventions

Control GroupsPropofolKetamine

Condition Hierarchy (Ancestors)

Treatment Adherence and ComplianceHealth BehaviorBehavior

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethodsPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsCyclohexanesCycloparaffinsHydrocarbons, Alicyclic

Study Officials

  • Cheol Lee, M.D.,Ph.D

    Wonkwang University Hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, M.D., Ph.D

Study Record Dates

First Submitted

September 22, 2024

First Posted

September 24, 2024

Study Start

September 19, 2024

Primary Completion

November 25, 2024

Study Completion

January 30, 2025

Last Updated

February 25, 2025

Record last verified: 2025-02

Locations