The Relationship Between Different Doses of Propofol and the Occurrence of Dreams in Short Surgery Under General Anesthesia

June 1, 2022 updated by: Yanchao Yang, Shengjing Hospital
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 .

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
300

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • China
    • Liaoning
      • Shenyang, Liaoning, China, 110004
        • Shengjing Hospital

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

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: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: Low maintenance dose propofol group
The low maintenance dose propofol group was maintained at 4-6 mg/kg/h
Drug: Propofol
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
EXPERIMENTAL: High maintenance dose propofol group
The high maintenance dose propofol group was maintained at 8-12 mg/kg/h
Drug: Propofol
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Mean blood pressure (systolic and diastolic)
Time Frame: 5 minutes after entering the operation room
record mean blood pressure during the surgery
5 minutes after entering the operation room
Mean blood pressure (systolic and diastolic)
Time Frame: Anesthesia induction to fall asleep
record mean blood pressure during the surgery
Anesthesia induction to fall asleep
Mean blood pressure (systolic and diastolic)
Time Frame: at the end of surgery
record mean blood pressure during the surgery
at the end of surgery
Mean blood pressure (systolic and diastolic)
Time Frame: Upon awakening from anesthesia
record mean blood pressure during the surgery
Upon awakening from anesthesia
Mean blood pressure (systolic and diastolic)
Time Frame: leaving the operation room
record mean blood pressure during the surgery
leaving the operation room
heart rate
Time Frame: entering the operation room
record heart rate during the surgery
entering the operation room
heart rate
Time Frame: Anesthesia induction to fall asleep
record heart rate during the surgery
Anesthesia induction to fall asleep
heart rate
Time Frame: at the end of surgery
record heart rate during the surgery
at the end of surgery
heart rate
Time Frame: Upon awakening from anesthesia
record heart rate during the surgery
Upon awakening from anesthesia
heart rate
Time Frame: leaving the operation room
record heart rate during the surgery
leaving the operation room
BIS
Time Frame: entering the operation room
record BIS during the surgery
entering the operation room
BIS
Time Frame: Anesthesia induction to fall asleep
record BIS during the surgery
Anesthesia induction to fall asleep
BIS
Time Frame: at the end of surgery
record BIS during the surgery
at the end of surgery
BIS
Time Frame: Upon awakening from anesthesia
record BIS during the surgery
Upon awakening from anesthesia
BIS
Time Frame: leaving the operation room
record BIS during the surgery
leaving the operation room
Total dose of propofol
Time Frame: at the end of surgery
record total dose of propofol
at the end of surgery
Dream
Time Frame: at the end of surgery
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Postoperative adverse effects
Time Frame: 24 hours after surgery
record postoperative adverse effects
24 hours after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Shengjing Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: junchao zhu, Shengjing 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 30, 2021

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 10, 2022

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 10, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 25, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 29, 2021

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 30, 2021

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 2, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 1, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Propofol and dream

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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