NCT05173688

Brief Summary

Dreams are a remarkable experiment in psychology and neuroscience, conducted every night in every sleeping person. 74% of awakenings from REM sleep resulted in recall of a dream, as compared with only 9% of awakenings from NREM sleep. The association between dreaming and REM sleep was subsequently replicated by many other investigators; typically, around 80% of REM awakenings yield dreams. It became clear over time that there is a good deal of mental activity that occurs during NREM sleep. Typically, it is more thought like, fragmentary, and related to daily concerns than the vivid, hallucinatory, predominantly visual narratives that are most commonly reported from REM sleep. But even this distinction appears not to be absolute. There is now wide acceptance of the view that some dreaming that is indistinguishable from REM sleep dreaming occurs in NREM sleep, most frequently in the sleep-onset period. General anesthesia causes a drug-induced state of unconsciousness and is a non-physiological process that is similar to natural sleep. Patients receiving propofol for maintenance of general anesthesia often report higher incidences of dreaming than patients maintained with volatile anesthetics. One explanation is that propofol and volatile anesthetic have different pharmacological effects in the central nervous system. An alternative explanation is that propofol is associated with more rapid emergence from anesthesia than the older volatile anesthetics, allowing patients to report their dreams before they are forgotten. In order to further verify the hypothesis, the investigators choose gynecological general anesthesia to observe whether the generation of dreams is related to the dose of general anesthesia maintenance .

Trial Health

87
On Track

Trial Health Score

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

Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2021

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 25, 2021

Completed
5 days until next milestone

Study Start

First participant enrolled

November 30, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

December 30, 2021

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 10, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 10, 2022

Completed
Last Updated

June 2, 2022

Status Verified

June 1, 2022

Enrollment Period

5 months

First QC Date

November 25, 2021

Last Update Submit

June 1, 2022

Conditions

DreamingGeneral Anesthesia

Outcome Measures

Primary Outcomes (17)

  • Mean blood pressure (systolic and diastolic)

    record mean blood pressure during the surgery

    5 minutes after entering the operation room

  • Mean blood pressure (systolic and diastolic)

    record mean blood pressure during the surgery

    Anesthesia induction to fall asleep

  • Mean blood pressure (systolic and diastolic)

    record mean blood pressure during the surgery

    at the end of surgery

  • Mean blood pressure (systolic and diastolic)

    record mean blood pressure during the surgery

    Upon awakening from anesthesia

  • Mean blood pressure (systolic and diastolic)

    record mean blood pressure during the surgery

    leaving the operation room

  • heart rate

    record heart rate during the surgery

    entering the operation room

  • heart rate

    record heart rate during the surgery

    Anesthesia induction to fall asleep

  • heart rate

    record heart rate during the surgery

    at the end of surgery

  • heart rate

    record heart rate during the surgery

    Upon awakening from anesthesia

  • heart rate

    record heart rate during the surgery

    leaving the operation room

  • BIS

    record BIS during the surgery

    entering the operation room

  • BIS

    record BIS during the surgery

    Anesthesia induction to fall asleep

  • BIS

    record BIS during the surgery

    at the end of surgery

  • BIS

    record BIS during the surgery

    Upon awakening from anesthesia

  • BIS

    record BIS during the surgery

    leaving the operation room

  • Total dose of propofol

    record total dose of propofol

    at the end of surgery

  • Dream

    Dreaming during anesthesia was defined as any experience that was described by the patient as dreaming and was thought by the patient to have occurred between the induction of anesthesia and the first moment of consciousness after anesthesia.27 Awareness was defined as postoperative recall of intraoperative events. All patients who reported dreaming were considered to be "dreamers" for the purpose of the analyses, whether or not they could remember the narrative of the dream. However, only dreaming reports where the narrative was remembered were classified using five-point Likert scales as follows. Emotional content (1 very negative; 5 very positive) ● Memorability (1 can't remember narrative of dream; 5 most memorable ever) ● Visual vividness (1 not at all vivid; 5 most vivid ever) ● Amount of sound (1 no sound; 5 most sound ever)

    at the end of surgery

Secondary Outcomes (1)

  • Postoperative adverse effects

    24 hours after surgery

Study Arms (2)

Low maintenance dose propofol group

EXPERIMENTAL

The low maintenance dose propofol group was maintained at 4-6 mg/kg/h

Drug: Propofol

High maintenance dose propofol group

EXPERIMENTAL

The high maintenance dose propofol group was maintained at 8-12 mg/kg/h

Drug: Propofol

Interventions

PropofolDRUG

The low maintenance dose propofol group was maintained at 4-6 mg/kg/h ；and The high maintenance dose propofol group was maintained at 8-12 mg/kg/h

High maintenance dose propofol groupLow maintenance dose propofol group

Eligibility Criteria

Age18 Years - 70 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • between 18 and 70 years
  • with an ASA physical status of I or II

You may not qualify if:

  • presence of sleep disorders
  • pain syndrome
  • cardiovascular disease
  • sleep apnea syndrome
  • psychosis
  • history of opioid usage
  • history of abnormal operation or anesthesia recovery
  • unwillingness to provide informed consent
  • a patient with a language communication disorder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shengjing Hospital

Shenyang, Liaoning, 110004, China

Location

MeSH Terms

Interventions

Propofol

Intervention Hierarchy (Ancestors)

PhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Study Officials

  • junchao zhu

    Shengjing Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

November 25, 2021

First Posted

December 30, 2021

Study Start

November 30, 2021

Primary Completion

May 10, 2022

Study Completion

May 10, 2022

Last Updated

June 2, 2022

Record last verified: 2022-06

Locations

CN(1)