DreamingNCT05173688
The Relationship Between Different Doses of Propofol and the Occurrence of Dreams in Short Surgery Under General Anesthesia
A study testing Propofol in people with Dreaming and General Anesthesia, run by Shengjing Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Dreaming, General Anesthesia
- What is being tested?
- Propofol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 30 Nov 2021to 10 May 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- between 18 and 70 years
- with an ASA physical status of I or II
Who cannot join
- presence of sleep disorders
- pain syndrome
- cardiovascular disease
- sleep apnea syndrome
- psychosis
- history of opioid usage
Show all 9Show fewer
- history of abnormal operation or anesthesia recovery
- unwillingness to provide informed consent
- a patient with a language communication disorder
Trial locations and contacts
1 site in 1 country.
About this study
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 .
- Conditions
- Dreaming, General Anesthesia
- Being tested
- Propofol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| Low maintenance dose propofol group | Experimental | The low maintenance dose propofol group was maintained at 4-6 mg/kg/h Receives: Drug: Propofol |
| High maintenance dose propofol group | Experimental | The high maintenance dose propofol group was maintained at 8-12 mg/kg/h Receives: Drug: Propofol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean blood pressure (systolic and diastolic)
record mean blood pressure during the surgery
Measured: 5 minutes after entering the operation room
Mean blood pressure (systolic and diastolic)
record mean blood pressure during the surgery
Measured: Anesthesia induction to fall asleep
Mean blood pressure (systolic and diastolic)
record mean blood pressure during the surgery
Measured: at the end of surgery
Mean blood pressure (systolic and diastolic)
record mean blood pressure during the surgery
Measured: Upon awakening from anesthesia
Mean blood pressure (systolic and diastolic)
record mean blood pressure during the surgery
Measured: leaving the operation room
heart rate
record heart rate during the surgery
Measured: entering the operation room
heart rate
record heart rate during the surgery
Measured: Anesthesia induction to fall asleep
heart rate
record heart rate during the surgery
Measured: at the end of surgery
heart rate
record heart rate during the surgery
Measured: Upon awakening from anesthesia
heart rate
record heart rate during the surgery
Measured: leaving the operation room
BIS
record BIS during the surgery
Measured: entering the operation room
BIS
record BIS during the surgery
Measured: Anesthesia induction to fall asleep
BIS
record BIS during the surgery
Measured: at the end of surgery
BIS
record BIS during the surgery
Measured: Upon awakening from anesthesia
BIS
record BIS during the surgery
Measured: leaving the operation room
Total dose of propofol
record total dose of propofol
Measured: 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)
Measured: at the end of surgery
Secondary outcomes (1)
Postoperative adverse effects
record postoperative adverse effects
Measured: 24 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2021
- Study start30 Nov 2021
- Primary completion10 May 2022
- Study completion10 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DreamingStudies of the same condition, open and under way.
- More trials run by Shengjing HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shengjing Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yanchao Yang, Shengjing Hospital
- Investigators
- junchao zhu, Principal investigator, Shengjing Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05173688
- Sponsor's protocol ID
- Propofol and dream
- Status last verified
- Jun 2022
- First submitted
- 25 Nov 2021
- Last updated
- 2 Jun 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship Between Different Doses of Propofol and the Occurrence of Dreams in Short Surgery Under General Anesthesia
- ClinicalTrials.gov ID
- NCT05173688
- Acronym / sponsor ID
- Propofol and dream
- Conditions
- Dreaming, General Anesthesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Shengjing HospitalUniversity, hospital or other
- Study start
- 30 Nov 2021 (actual)
- Primary completion
- 10 May 2022 (actual)
- Study completion
- 10 May 2022 (actual)
- First posted
- 30 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low maintenance dose propofol group | Experimental | Drug: PropofolThe low maintenance dose propofol group was maintained at 4-6 mg/kg/h |
| High maintenance dose propofol group | Experimental | Drug: PropofolThe high maintenance dose propofol group was maintained at 8-12 mg/kg/h |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- between 18 and 70 years
- with an ASA physical status of I or II
Key exclusion criteria (9 listed)
- presence of sleep disorders
- pain syndrome
- cardiovascular disease
- sleep apnea syndrome
- psychosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PropofolThe 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 | Drug | High maintenance dose propofol group, Low maintenance dose propofol group |
Primary outcome
Mean blood pressure (systolic and diastolic)
Time frame: 5 minutes after entering the operation room
record mean blood pressure during the surgery
Mean blood pressure (systolic and diastolic)
Time frame: Anesthesia induction to fall asleep
record mean blood pressure during the surgery
Mean blood pressure (systolic and diastolic)
Time frame: at the end of surgery
record mean blood pressure during the surgery
Mean blood pressure (systolic and diastolic)
Time frame: Upon awakening from anesthesia
record mean blood pressure during the surgery
Mean blood pressure (systolic and diastolic)
Time frame: leaving the operation room
record mean blood pressure during the surgery
heart rate
Time frame: entering the operation room
record heart rate during the surgery
heart rate
Time frame: Anesthesia induction to fall asleep
record heart rate during the surgery
heart rate
Time frame: at the end of surgery
record heart rate during the surgery
heart rate
Time frame: Upon awakening from anesthesia
record heart rate during the surgery
heart rate
Time frame: leaving the operation room
record heart rate during the surgery
BIS
Time frame: entering the operation room
record BIS during the surgery
BIS
Time frame: Anesthesia induction to fall asleep
record BIS during the surgery
BIS
Time frame: at the end of surgery
record BIS during the surgery
BIS
Time frame: Upon awakening from anesthesia
record BIS during the surgery
BIS
Time frame: leaving the operation room
record BIS during the surgery
Total dose of propofol
Time frame: at the end of surgery
record total dose of propofol
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)
1 secondary outcome
Postoperative adverse effects
Time frame: 24 hours after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
junchao zhu principal investigator
Shengjing Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Propofol in people with Dreaming and General Anesthesia, run by Shengjing Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean blood pressure (systolic and diastolic) (time frame: 5 minutes after entering the operation room). The study lists 17 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2022.