DreamingNCT05357872
Dreaming During Anesthesia and Anesthetic Depth in Elective Surgery Patients Under General Anesthesia
A study testing deep anesthesia depth and light anesthesia depth in people with Dreaming and General Anesthesia, run by Shengjing Hospital at 1 site in China.
Trial summary
Dreaming is a common, enduring, and fascinating part of the anesthetic experience, but its cause and timing remain elusive. Patients typically report that they were dreaming during anesthesia, but the actual timing of anesthetic dreaming is unknown. 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?
- deep anesthesia depth and light anesthesia depth
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2021to 31 Jul 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.
China1 site, 1 recruiting
- Recruiting
Shengjing Hospital
Shenyang, Liaoning, 110004
junchao zhu, +8618940257257, zhujunchao1@hotmail.com
About this study
Dreaming is a common, enduring, and fascinating part of the anesthetic experience, but its cause and timing remain elusive. Patients typically report that they were dreaming during anesthesia, but the actual timing of anesthetic dreaming is unknown. The following evidence supports the hypothesis that dreaming occurs intraoperatively and is related to light or inadequate anesthesia: (1) The incidence of dreaming has decreased as anesthetic techniques have improved; (2) dreamers exhibit more clinical signs of light anesthesia or report more awareness than non dreamers; (3) dreamers may receive lower doses of anesthetic drugs than non dreamers and emerge more rapidly from anesthesia; (4) the content of dreams may involve surgical topics or events occurring during anesthesia; and (5) in one study, the incidence of dreaming was lower in Bispectral Index (BIS)-monitored patients. Alternatively, dreaming may occur during emergence from anesthesia, when the brain is still affected by sedative concentrations of anesthetic drugs and the patient enters a sleep state. Few studies have assessed the relation between dreaming and depth of anesthesia, and their results were inconclusive.Most recently, in the B-Aware Trial, no differences in depth of anesthesia, as measured by BIS, were detected between dreamers and non dreamers. However, the patients were at high risk of awareness, and BIS data were collected manually and were only recorded in the BIS group and during maintenance. No studies investigating the relation between dreaming and depth of anesthesia during recovery were identified. Why is the investigation of dreaming during anesthesia important? Dreaming is one of the most common side effects of anesthesia but remains puzzling and requires explanation. Dreaming is sometimes distressing to patients and may decrease satisfaction with care. Some patients who report dreaming fear that their anesthetic was inadequate and that their experience was, in fact, awareness. Indeed, in a minority of cases, dreaming may truly represent near-miss awareness. The investigators therefore tested the hypothesis that dreaming during anesthesia is associated with light or inadequate anesthesia, as evidenced by higher median BIS values during maintenance of anesthesia. The investigators also explored the depth of anesthesia until emergence, the form and content of dreams, the predictors of dreaming during anesthesia, and the effect of dreaming on quality of recovery and satisfaction with anesthetic care
- Conditions
- Dreaming, General Anesthesia
- Being tested
- deep anesthesia depth, light anesthesia depth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
deep anesthesia depthDevice
The anesthesiologist adjusted the intravenous speed of remifentanil and propofol to maintain the bispectral index (BIS, BIS monitor; Aspect Medical System, Newton, MA) between 40-50 and 50-60 during the operation.
light anesthesia depthDevice
The anesthesiologist adjusted the intravenous speed of remifentanil and propofol to maintain the bispectral index (BIS, BIS monitor; Aspect Medical System, Newton, MA) between 40-50 and 50-60 during the operation.
| Study group | Role | What they receive |
|---|---|---|
| BIS 40-50 Group | Experimental | The anesthesiologist adjusted the intravenous speed of remifentanil and propofol to maintain the bispectral index (BIS, BIS monitor; Aspect Medical System, Newton, MA) between 40-50 Receives: Device: deep anesthesia depth |
| BIS 50-60 Group | Experimental | The anesthesiologist adjusted the intravenous speed of remifentanil and propofol to maintain the bispectral index (BIS, BIS monitor; Aspect Medical System, Newton, MA) between 50-60 during the operation. Receives: Device: light anesthesia depth |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean blood pressure
record mean blood pressure during the surgery. Systolic, diastolic, or both pressures don't need to be assessed during the study period.
Measured: 5 minutes after entering the operation room
Mean blood pressure
record mean blood pressure during the surgery. Systolic, diastolic, or both pressures don't need to be assessed during the study period.
Measured: procedure (anesthesia induction)
Mean blood pressure
record mean blood pressure during the surgery. Systolic, diastolic, or both pressures don't need to be assessed during the study period.
Measured: at the end of surgery
Mean blood pressure
record mean blood pressure during the surgery. Systolic, diastolic, or both pressures don't need to be assessed during the study period.
Measured: procedure (anesthesia extubation)
Mean blood pressure
record mean blood pressure during the surgery. Systolic, diastolic, or both pressures don't need to be assessed during the study period.
Measured: the time when leaving the operation room
heart rate
record heart rate during the surgery
Measured: 5 minutes after entering the operation room
heart rate
record heart rate during the surgery
Measured: procedure (Anesthesia induction)
heart rate
record heart rate during the surgery
Measured: at the end of surgery
heart rate
record heart rate during the surgery
Measured: procedure (anesthesia extubation)
heart rate
record heart rate during the surgery
Measured: the time when leaving the operation room
Bispectral Index (BIS)
record BIS during the surgery. The range was 0-100. We control the range of BIS in 40-60 during the surgery
Measured: 5 minutes after entering the operation room
Bispectral Index (BIS)
record BIS during the surgery. record BIS during the surgery. The range was 0-100. We control the range of BIS in 40-60 during the surgery
Measured: procedure (Anesthesia induction)
Bispectral Index (BIS)
record BIS during the surgery. record BIS during the surgery. The range was 0-100. We control the range of BIS in 40-60 during the surgery
Measured: at the end of surgery
Bispectral Index (BIS)
record BIS during the surgery. record BIS during the surgery. The range was 0-100. We control the range of BIS in 40-60 during the surgery
Measured: procedure (anesthesia extubation)
Bispectral Index (BIS)
record BIS during the surgery. record BIS during the surgery. The range was 0-100. We control the range of BIS in 40-60 during the surgery
Measured: the time when 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 posted3 May 2022
- Study start1 Dec 2021
- Primary completion30 Jun 2022 (estimated)
- Study completion31 Jul 2022 (estimated)
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
- 100 participants (estimated)
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
- NCT05357872
- Sponsor's protocol ID
- BIS and dream
- Status last verified
- Apr 2022
- First submitted
- 25 Nov 2021
- Last updated
- 3 May 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 3 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dreaming During Anesthesia and Anesthetic Depth in Elective Surgery Patients Under General Anesthesia
- ClinicalTrials.gov ID
- NCT05357872
- Acronym / sponsor ID
- BIS and dream
- Conditions
- Dreaming, General Anesthesia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Shengjing HospitalUniversity, hospital or other
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- 30 Jun 2022 (estimated)
- Study completion
- 31 Jul 2022 (estimated)
- First posted
- 3 May 2022 (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.
Dreaming is a common, enduring, and fascinating part of the anesthetic experience, but its cause and timing remain elusive. Patients typically report that they were dreaming during anesthesia, but the actual timing of anesthetic dreaming is unknown. The following evidence supports the hypothesis that dreaming occurs intraoperatively and is related to light or inadequate anesthesia: (1) The incidence of dreaming has decreased as anesthetic techniques have improved; (2) dreamers exhibit more clinical signs of light anesthesia or report more awareness than non dreamers; (3) dreamers may receive lower doses of anesthetic drugs than non dreamers and emerge more rapidly from anesthesia; (4) the content of dreams may involve surgical topics or events occurring during anesthesia; and (5) in one study, the incidence of dreaming was lower in Bispectral Index (BIS)-monitored patients. Alternatively, dreaming may occur during emergence from anesthesia, when the brain is still affected by sedative concentrations of anesthetic drugs and the patient enters a sleep state. Few studies have assessed the relation between dreaming and depth of anesthesia, and their results were inconclusive.Most recently, in the B-Aware Trial, no differences in depth of anesthesia, as measured by BIS, were detected between dreamers and non dreamers. However, the patients were at high risk of awareness, and BIS data were collected manually and were only recorded in the BIS group and during maintenance. No studies investigating the relation between dreaming and depth of anesthesia during recovery were identified. Why is the investigation of dreaming during anesthesia important? Dreaming is one of the most common side effects of anesthesia but remains puzzling and requires explanation. Dreaming is sometimes distressing to patients and may decrease satisfaction with care. Some patients who report dreaming fear that their anesthetic was inadequate and that their experience was, in fact, awareness. Indeed, in a minority of cases, dreaming may truly represent near-miss awareness. The investigators therefore tested the hypothesis that dreaming during anesthesia is associated with light or inadequate anesthesia, as evidenced by higher median BIS values during maintenance of anesthesia. The investigators also explored the depth of anesthesia until emergence, the form and content of dreams, the predictors of dreaming during anesthesia, and the effect of dreaming on quality of recovery and satisfaction with anesthetic care
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 |
|---|---|---|
| BIS 40-50 Group | Experimental | Device: deep anesthesia depthThe anesthesiologist adjusted the intravenous speed of remifentanil and propofol to maintain the bispectral index (BIS, BIS monitor; Aspect Medical System, Newton, MA) between 40-50 |
| BIS 50-60 Group | Experimental | Device: light anesthesia depthThe anesthesiologist adjusted the intravenous speed of remifentanil and propofol to maintain the bispectral index (BIS, BIS monitor; Aspect Medical System, Newton, MA) between 50-60 during the operation. |
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 |
|---|---|---|
| deep anesthesia depthThe anesthesiologist adjusted the intravenous speed of remifentanil and propofol to maintain the bispectral index (BIS, BIS monitor; Aspect Medical System, Newton, MA) between 40-50 and 50-60 during the operation. | Device | BIS 40-50 Group |
| light anesthesia depthThe anesthesiologist adjusted the intravenous speed of remifentanil and propofol to maintain the bispectral index (BIS, BIS monitor; Aspect Medical System, Newton, MA) between 40-50 and 50-60 during the operation. | Device | BIS 50-60 Group |
Primary outcome
Mean blood pressure
Time frame: 5 minutes after entering the operation room
record mean blood pressure during the surgery. Systolic, diastolic, or both pressures don't need to be assessed during the study period.
Mean blood pressure
Time frame: procedure (anesthesia induction)
record mean blood pressure during the surgery. Systolic, diastolic, or both pressures don't need to be assessed during the study period.
Mean blood pressure
Time frame: at the end of surgery
record mean blood pressure during the surgery. Systolic, diastolic, or both pressures don't need to be assessed during the study period.
Mean blood pressure
Time frame: procedure (anesthesia extubation)
record mean blood pressure during the surgery. Systolic, diastolic, or both pressures don't need to be assessed during the study period.
Mean blood pressure
Time frame: the time when leaving the operation room
record mean blood pressure during the surgery. Systolic, diastolic, or both pressures don't need to be assessed during the study period.
heart rate
Time frame: 5 minutes after entering the operation room
record heart rate during the surgery
heart rate
Time frame: procedure (Anesthesia induction)
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: procedure (anesthesia extubation)
record heart rate during the surgery
heart rate
Time frame: the time when leaving the operation room
record heart rate during the surgery
Bispectral Index (BIS)
Time frame: 5 minutes after entering the operation room
record BIS during the surgery. The range was 0-100. We control the range of BIS in 40-60 during the surgery
Bispectral Index (BIS)
Time frame: procedure (Anesthesia induction)
record BIS during the surgery. record BIS during the surgery. The range was 0-100. We control the range of BIS in 40-60 during the surgery
Bispectral Index (BIS)
Time frame: at the end of surgery
record BIS during the surgery. record BIS during the surgery. The range was 0-100. We control the range of BIS in 40-60 during the surgery
Bispectral Index (BIS)
Time frame: procedure (anesthesia extubation)
record BIS during the surgery. record BIS during the surgery. The range was 0-100. We control the range of BIS in 40-60 during the surgery
Bispectral Index (BIS)
Time frame: the time when leaving the operation room
record BIS during the surgery. record BIS during the surgery. The range was 0-100. We control the range of BIS in 40-60 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
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 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 deep anesthesia depth and light anesthesia depth 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: status not confirmed, as of the sponsor's last update on 3 May 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact junchao zhu (+8618940257257, zhujunchao1@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean blood pressure (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 3 May 2022.