- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05173688
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
Study Type
Interventional
Enrollment (Actual)
300
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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Liaoning
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Shenyang, Liaoning, China, 110004
- Shengjing Hospital
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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
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 |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: Low maintenance dose propofol group
The low maintenance dose propofol group was maintained at 4-6 mg/kg/h
|
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
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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
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
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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
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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
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at the end of surgery
|
|
Mean blood pressure (systolic and diastolic)
Time Frame: Upon awakening from anesthesia
|
record mean blood pressure during the surgery
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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
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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
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
Investigators
- 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)
November 30, 2021
Primary Completion (ACTUAL)
May 10, 2022
Study Completion (ACTUAL)
May 10, 2022
Study Registration Dates
First Submitted
November 25, 2021
First Submitted That Met QC Criteria
December 29, 2021
First Posted (ACTUAL)
December 30, 2021
Study Record Updates
Last Update Posted (ACTUAL)
June 2, 2022
Last Update Submitted That Met QC Criteria
June 1, 2022
Last Verified
June 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID 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
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