- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05357872
Dreaming During Anesthesia and Anesthetic Depth in Elective Surgery Patients Under General Anesthesia
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Liaoning
-
Shenyang, Liaoning, China, 110004
- Recruiting
- Shengjing Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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: BIS 40-50 Group
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
|
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.
|
EXPERIMENTAL: BIS 50-60 Group
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
heart rate
Time Frame: at the end of surgery
|
record heart rate during the surgery
|
at the end of surgery
|
Total dose of propofol
Time Frame: at the end of surgery
|
record total dose of propofol
|
at the end of surgery
|
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.
|
5 minutes after entering the operation room
|
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.
|
procedure (anesthesia induction)
|
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.
|
at the end of surgery
|
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.
|
procedure (anesthesia extubation)
|
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.
|
the time when leaving the operation room
|
heart rate
Time Frame: 5 minutes after entering the operation room
|
record heart rate during the surgery
|
5 minutes after entering the operation room
|
heart rate
Time Frame: procedure (Anesthesia induction)
|
record heart rate during the surgery
|
procedure (Anesthesia induction)
|
heart rate
Time Frame: procedure (anesthesia extubation)
|
record heart rate during the surgery
|
procedure (anesthesia extubation)
|
heart rate
Time Frame: the time when leaving the operation room
|
record heart rate during the surgery
|
the time when leaving the operation room
|
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
|
5 minutes after entering the operation room
|
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
|
procedure (Anesthesia induction)
|
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
|
at the end of 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
|
procedure (anesthesia extubation)
|
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
|
the time when leaving the operation room
|
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
Sponsor
Investigators
- Principal Investigator: junchao zhu, Shengjing Hospital
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- BIS and dream
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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