Cognitive FunctioningNCT06775366
The Effect of General Anesthesia with Remimazolam and Propofol on Rhythmic State and Cognitive Function
A study testing Remimazolam and propofol in people with Cognitive Functioning and Propofol, run by The Second Affiliated Hospital of Chongqing Medical University at 1 site in China.
Trial summary
This study want to observe the effects of remimazolam and propofol for general anesthesia on postoperative rhythm and cognitive function. The observation group was given remimazolam for general anesthesia, and the control group was given propofol for general anesthesia. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Cognitive Functioning, Propofol, Remimazolam
- What is being tested?
- Remimazolam and propofol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 174 participants
- Where
- 1 siteChina
- Study dates
- 24 Feb 2025to 30 May 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 18-65 years old, ASAI-III class, BMI18.5-25kg/m2 Inpatients undergoing laparoscopic cholecystectomy The estimated time of operation is 1.5~2.5 hours Preoperative brief mental status examination (MMSE) score ≥24 Voluntary participation and signed informed consent
Who cannot join
- Pregnant or lactating women Patients who are allergic to remimazolam or contraindicated Patients who are dependent on or tolerant to opioids or have long-term alcoholism Serious cardiovascular system, respiratory system, liver and kidney diseases History of obstructive sleep apnea mental disorders or neurological diseases Patients who participated in clinical trials of other drugs within the last 3 months The attending physician or researcher considers that there are other circumstances that are not suitable for participation in this study Refuse to participate in the study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
The Second Affiliated Hospital of Chongqing Medical University
Chongqing, 400000
He Huang, ph.D, 86+13708385559, huanghe@cqmu.edu.cn
About this study
Official title: Effects of General Anesthesia with Remimazolam and Propofol on Rhythmic State and Cognitive Function
This study want to observe the effects of remimazolam and propofol for general anesthesia on postoperative rhythm and cognitive function. The observation group was given remimazolam for general anesthesia, and the control group was given propofol for general anesthesia. Both drugs are commonly used as intravenous anesthetics for general anesthesia and have been shown to be safe for use in general anesthesia. The investigators hope can understand the effects of remimazolam and propofol for general anesthesia on rhythm status and cognitive function through this study, further reduce the occurrence of postoperative cognitive function impairment, and enable subjects to better recover.
Read the detailed description
Benzodiazepines are one of the most important and commonly used intravenous sedatives in the perioperative period. However, benzodiazepines are often associated with a variety of side effects, including respiratory depression, cardiovascular depression, excessive sedation, delayed recovery, disturbance of consciousness, dizziness and nausea, postoperative delirium, and postoperative cognitive impairment. Remimazolam is a new type of benzodiazepine anesthetic drug. It can be rapidly hydrolyzed into inactive carboxylic acid metabolites by widely existing carboxylesterases in the human body. Therefore, it has the characteristics of fast onset, fast metabolism, little impact on liver and kidney function, and little inhibition of respiratory circulation. However, as a benzodiazepine, remimazolam has little effect on postoperative cognitive function.
Biorhythms are currently a hot topic in medical research. Many organisms, including mammals, have the suprachiasmatic nucleus (SCN), a circadian clock pacemaker located in the hypothalamus, which drives the rhythms of activity and rest, fasting and eating, body temperature and hormones to synchronize to 24 hours. Many anesthetic drugs, such as propofol, dexmedetomidine, and volatile anesthetic drugs such as sevoflurane and desflurane, interfere with the expression of circadian rhythm genes in mammals. For example, the expression of rhythm genes per1 and per2 in supratasmatic nucleus of rats injected with a single dose of propofol is down-regulated, and irregular resting activity rhythm is observed in patients undergoing colonoscopy under anesthesia with propofol. The circadian period of patients undergoing general anesthesia is obviously advanced, and the disturbance of circadian rhythm is an important feature of postoperative sleep disorders. However, sleep disorders can aggravate postoperative delirium and postoperative cognitive dysfunction, and related rhythm genes such as Dbp participate in the plasticity of the hippocampus, so the interference of anesthesia drugs on the biological rhythm of the body may be an important cause of postoperative cognitive dysfunction. Since propofol is commonly used in clinical intravenous anesthesia, this study intends to compare the effects of remimazolam and propofol on patients' activity rest rhythm and their effects on learning and memory functions.
- Conditions
- Cognitive Functioning, Propofol, Remimazolam, Circadian Rhythm
- Being tested
- Remimazolam, propofol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RemimazolamDrug
Remimazolam 6mg/kg/h was pumped intravenously for 2.5 min, Sufentanil 0.5 μg/kg and rocuronium 0.6mg/kg were injected intravenously, and endotracheal intubation was performed 3 minutes later. Remimazolam was then pumped at 1 mg/kg/h, the BIS was kept in the range of 40-60 through general anesthesia, and the remimazolam infusion rate was adjusted (0.5-3 mg/kg/h).If the BIS cannot be maintained at ≤ 60 or there are signs of potential inadequate anesthesia (such as cough, sweating, and patient movement), and the maximum infusion dose of remimazolam has been given, supplemental sedation with the remedial drug sevoflurane or propofol is used and the case is dismissed.
propofolDrug
Propofol (2-3mg/kg), Sufentanil (0.5μg /kg), rocuronium (0.6mg/kg) were injected intravenously, and endotracheal intubation was performed for 3 minutes. Subsequently, propofol was pumped at 4-10mg/kg/h to maintain the BIS in the range of 40-60.
| Study group | Role | What they receive |
|---|---|---|
| remimazolam for general anesthesia | Experimental | Remimazolam 6mg/kg/h was pumped intravenously for 2.5 min, Sufentanil 0.5 μg/kg and rocuronium 0.6mg/kg were injected intravenously, and endotracheal intubation was performed 3 minutes later. Remimazolam was then pumped at 1 mg/kg/h, the BIS was kept in the range of 40-60 through general anesthesia, and the remimazolam infusion rate was adjusted (0.5-3 mg/kg/h).If the BIS cannot be maintained at ≤ 60 or there are signs of potential inadequate anesthesia (such as cough, sweating, and patient movement), and the maximum infusion dose of remimazolam has been given, supplemental sedation with the remedial drug sevoflurane or propofol is used and the case is dismissed. Receives: Drug: Remimazolam |
| propofol for general anesthesia | Active comparator | Propofol (2-3mg/kg), Sufentanil (0.5μg /kg), rocuronium (0.6mg/kg) were injected intravenously, and endotracheal intubation was performed for 3 minutes. Subsequently, propofol was pumped at 4-10mg/kg/h to maintain the BIS in the range of 40-60. Receives: Drug: propofol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cognitive function
The digital symbol task was measured 30 minutes after extubation and 24 hours after surgery to assess the patient's attention and executive ability. The test requires subjects to quickly transcribe numbers into symbols within their line of sight. The score is the number of correct numeric symbols recorded by the subject within 20 seconds.
Measured: 30 minutes after extubation and 24 hours after surgery
Cognitive function
The finger tap test was measured 30 minutes after extubation and 24 hours after surgery to assess the fine motor ability. The average stroke number of a normal person within a 10-second time limit is about 40, and the speed of the right hand is about 1.1 times that of the left hand. The test includes a keystroke and a device that records the number of keystrokes. We performed this test using a tablet: a square area was placed in the middle of the screen to allow the subject to click as quickly as possible, while the tablet automatically recorded the completion time.The subjects were asked to complete 10 seconds of tapping with each hand separately and take short breaks between each test.Record the number of strokes each hand completes in 10 seconds.
Measured: 30 minutes after extubation and 24 hours after surgery
Cognitive function
The digital span test was measured 30 minutes after extubation and 24 hours after surgery to assess the short-term memory. The digital span test assays memory ability and attention span by having subjects recall the correct number immediately after seeing a randomly appearing string of numbers and input it into an electronic device, and increase the length of the string one digit at a time after remembering it correctly. Record the length of the numeric string that the subject can eventually recall.
Measured: 30 minutes after extubation and 24 hours after surgery
Cognitive function
The stroop color word test was measured 30 minutes after extubation and 24 hours after surgery to assess the distraction and conditioned reflex suppression. Mixing words with different colors and meanings and the same meaning in the center of the screen (for example, on the word "green" written in red) requires subjects to quickly select the meaning of the word and suppress automatic reflexes to recognize the color. Record the subject completion time.
Measured: 30 minutes after extubation and 24 hours after surgery
Cognitive function
The schulte square test was measured 30 minutes after extubation and 24 hours after surgery to assess the patient attention level ability. The investigators used a tablet to do this test: there are 16 grids in the center of the screen. The grid is arbitrarily filled with Arabic numerals 1-16, with a total of 16 digits. During the test, participants were asked to manually click on number locations in order of 1-16, and only after clicking the correct location could they proceed to the next number click. The software automatically records the time spent. Subjects were asked to complete two trials each time, with a short break between each trial, and to record the shortest time to complete the trial between the two tests.
Measured: 30 minutes after extubation and 24 hours after surgery
Secondary outcomes (10)
Patient activity/rest condition
From 24 hours before surgery to 24 hours after surgery, the patient will wear a Huawei sports bracelet to record the patient's activity and rest condition
Measured: 30 minutes after extubation and 24 hours after surgery
The quality of recovery score
The quality of postoperative recovery was assessed by quality of recovery score-15(QoR-15). The quality of postoperative recovery score includes 15 questions, with a maximum of 10 points for each question, a maximum of 150 points, and a minimum of 0 points. The higher the score, the better the patient's recovery quality.
Measured: 24 hours after surgery to complete the QoR-15 score assessment
ramsay sedation score
The degree of sedation was assessed by ramsay sedation score.1 score: restlessness;2 points: sober, quiet and cooperative;3 points: lethargy, quick response to instructions;4 points: light sleep state, can quickly wake up;5 points: sleep, slow response to calls;6 points: Deep sleep, unresponsive to calls.
Measured: 30min after extubation to complete the ramsay sedation score assessment
Anesthesia adverse events
such as hypotension, hypertension, bradycardia or other anesthesia adverse events
Measured: during surgery
drug-related adverse reactions
Adverse reactions, such as respiratory depression, itching, coughing, irritability, drowsiness, dizziness, delirium, or other adverse reactions
Measured: during surgery
Use of vasoactive drugs
The use of vasoactive drugs during the operation was recorded
Measured: during surgery
fluid volume
Record the Infusion volume during the surgery
Measured: during surgery
Record the time of extubation
Record the time of extubation
Measured: From the end of the surgery to leaving the postoperative recovery room
Numerical rating scale 24 hours after surgery
The degree of postoperative pain was assessed by the numerical rating scale(NRS). A minimum score of 0 means no pain. A maximum score of 10 represents the highest level of pain.
Measured: from 24 hours after surgery to complete the NRS pain assessment
Postoperative nausea numerical rating scale
The degree of postoperative nausea was assessed by the nausea numerical rating scale. A minimum score of 0 means no nausea. The highest score of 10, represents the most intense nausea.
Measured: from 24 hours after surgery to complete the postoperative nausea NRS score
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2025
- Study start24 Feb 2025 (estimated)
- Primary completion30 Apr 2026 (estimated)
- Study completion30 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive FunctioningStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 174 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Second Affiliated Hospital of Chongqing Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06775366
- Sponsor's protocol ID
- RPPOCD
- Status last verified
- Dec 2024
- First submitted
- 1 Jan 2025
- Last updated
- 14 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of General Anesthesia with Remimazolam and Propofol on Rhythmic State and Cognitive Function
- ClinicalTrials.gov ID
- NCT06775366
- Acronym / sponsor ID
- RPPOCD
- Conditions
- Cognitive Functioning, Propofol, Remimazolam, Circadian Rhythm
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 174 participants (estimated)
- Lead sponsor
- The Second Affiliated Hospital of Chongqing Medical UniversityUniversity, hospital or other
- Study start
- 24 Feb 2025 (estimated)
- Primary completion
- 30 Apr 2026 (estimated)
- Study completion
- 30 May 2026 (estimated)
- First posted
- 15 Jan 2025 (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.
This study want to observe the effects of remimazolam and propofol for general anesthesia on postoperative rhythm and cognitive function. The observation group was given remimazolam for general anesthesia, and the control group was given propofol for general anesthesia. Both drugs are commonly used as intravenous anesthetics for general anesthesia and have been shown to be safe for use in general anesthesia. The investigators hope can understand the effects of remimazolam and propofol for general anesthesia on rhythm status and cognitive function through this study, further reduce the occurrence of postoperative cognitive function impairment, and enable subjects to better recover.
Detailed description
Benzodiazepines are one of the most important and commonly used intravenous sedatives in the perioperative period. However, benzodiazepines are often associated with a variety of side effects, including respiratory depression, cardiovascular depression, excessive sedation, delayed recovery, disturbance of consciousness, dizziness and nausea, postoperative delirium, and postoperative cognitive impairment. Remimazolam is a new type of benzodiazepine anesthetic drug. It can be rapidly hydrolyzed into inactive carboxylic acid metabolites by widely existing carboxylesterases in the human body. Therefore, it has the characteristics of fast onset, fast metabolism, little impact on liver and kidney function, and little inhibition of respiratory circulation. However, as a benzodiazepine, remimazolam has little effect on postoperative cognitive function.
Biorhythms are currently a hot topic in medical research. Many organisms, including mammals, have the suprachiasmatic nucleus (SCN), a circadian clock pacemaker located in the hypothalamus, which drives the rhythms of activity and rest, fasting and eating, body temperature and hormones to synchronize to 24 hours. Many anesthetic drugs, such as propofol, dexmedetomidine, and volatile anesthetic drugs such as sevoflurane and desflurane, interfere with the expression of circadian rhythm genes in mammals. For example, the expression of rhythm genes per1 and per2 in supratasmatic nucleus of rats injected with a single dose of propofol is down-regulated, and irregular resting activity rhythm is observed in patients undergoing colonoscopy under anesthesia with propofol. The circadian period of patients undergoing general anesthesia is obviously advanced, and the disturbance of circadian rhythm is an important feature of postoperative sleep disorders. However, sleep disorders can aggravate postoperative delirium and postoperative cognitive dysfunction, and related rhythm genes such as Dbp participate in the plasticity of the hippocampus, so the interference of anesthesia drugs on the biological rhythm of the body may be an important cause of postoperative cognitive dysfunction. Since propofol is commonly used in clinical intravenous anesthesia, this study intends to compare the effects of remimazolam and propofol on patients' activity rest rhythm and their effects on learning and memory functions.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| remimazolam for general anesthesia | Experimental | Drug: RemimazolamRemimazolam 6mg/kg/h was pumped intravenously for 2.5 min, Sufentanil 0.5 μg/kg and rocuronium 0.6mg/kg were injected intravenously, and endotracheal intubation was performed 3 minutes later. Remimazolam was then pumped at 1 mg/kg/h, the BIS was kept in the range of 40-60 through general anesthesia, and the remimazolam infusion rate was adjusted (0.5-3 mg/kg/h).If the BIS cannot be maintained at ≤ 60 or there are signs of potential inadequate anesthesia (such as cough, sweating, and patient movement), and the maximum infusion dose of remimazolam has been given, supplemental sedation with the remedial drug sevoflurane or propofol is used and the case is dismissed. |
| propofol for general anesthesia | Active comparator | Drug: propofolPropofol (2-3mg/kg), Sufentanil (0.5μg /kg), rocuronium (0.6mg/kg) were injected intravenously, and endotracheal intubation was performed for 3 minutes. Subsequently, propofol was pumped at 4-10mg/kg/h to maintain the BIS in the range of 40-60. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Age 18-65 years old, ASAI-III class, BMI18.5-25kg/m2 Inpatients undergoing laparoscopic cholecystectomy The estimated time of operation is 1.5~2.5 hours Preoperative brief mental status examination (MMSE) score ≥24 Voluntary participation and signed informed consent
Key exclusion criteria (1 listed)
- Pregnant or lactating women Patients who are allergic to remimazolam or contraindicated Patients who are dependent on or tolerant to opioids or have long-term alcoholism Serious cardiovascular system, respiratory system, liver and kidney diseases History of obstructive sleep apnea mental disorders or neurological diseases Patients who participated in clinical trials of other drugs within the last 3 months The attending physician or researcher considers that there are other circumstances that are not suitable for participation in this study Refuse to participate in the study
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 |
|---|---|---|
| RemimazolamRemimazolam 6mg/kg/h was pumped intravenously for 2.5 min, Sufentanil 0.5 μg/kg and rocuronium 0.6mg/kg were injected intravenously, and endotracheal intubation was performed 3 minutes later. Remimazolam was then pumped at 1 mg/kg/h, the BIS was kept in the range of 40-60 through general anesthesia, and the remimazolam infusion rate was adjusted (0.5-3 mg/kg/h).If the BIS cannot be maintained at ≤ 60 or there are signs of potential inadequate anesthesia (such as cough, sweating, and patient movement), and the maximum infusion dose of remimazolam has been given, supplemental sedation with the remedial drug sevoflurane or propofol is used and the case is dismissed. | Drug | remimazolam for general anesthesia |
| propofolPropofol (2-3mg/kg), Sufentanil (0.5μg /kg), rocuronium (0.6mg/kg) were injected intravenously, and endotracheal intubation was performed for 3 minutes. Subsequently, propofol was pumped at 4-10mg/kg/h to maintain the BIS in the range of 40-60. | Drug | propofol for general anesthesia |
Primary outcome
Cognitive function
Time frame: 30 minutes after extubation and 24 hours after surgery
The digital symbol task was measured 30 minutes after extubation and 24 hours after surgery to assess the patient's attention and executive ability. The test requires subjects to quickly transcribe numbers into symbols within their line of sight. The score is the number of correct numeric symbols recorded by the subject within 20 seconds.
Cognitive function
Time frame: 30 minutes after extubation and 24 hours after surgery
The finger tap test was measured 30 minutes after extubation and 24 hours after surgery to assess the fine motor ability. The average stroke number of a normal person within a 10-second time limit is about 40, and the speed of the right hand is about 1.1 times that of the left hand. The test includes a keystroke and a device that records the number of keystrokes. We performed this test using a tablet: a square area was placed in the middle of the screen to allow the subject to click as quickly as possible, while the tablet automatically recorded the completion time.The subjects were asked to complete 10 seconds of tapping with each hand separately and take short breaks between each test.Record the number of strokes each hand completes in 10 seconds.
Cognitive function
Time frame: 30 minutes after extubation and 24 hours after surgery
The digital span test was measured 30 minutes after extubation and 24 hours after surgery to assess the short-term memory. The digital span test assays memory ability and attention span by having subjects recall the correct number immediately after seeing a randomly appearing string of numbers and input it into an electronic device, and increase the length of the string one digit at a time after remembering it correctly. Record the length of the numeric string that the subject can eventually recall.
Cognitive function
Time frame: 30 minutes after extubation and 24 hours after surgery
The stroop color word test was measured 30 minutes after extubation and 24 hours after surgery to assess the distraction and conditioned reflex suppression. Mixing words with different colors and meanings and the same meaning in the center of the screen (for example, on the word "green" written in red) requires subjects to quickly select the meaning of the word and suppress automatic reflexes to recognize the color. Record the subject completion time.
Cognitive function
Time frame: 30 minutes after extubation and 24 hours after surgery
The schulte square test was measured 30 minutes after extubation and 24 hours after surgery to assess the patient attention level ability. The investigators used a tablet to do this test: there are 16 grids in the center of the screen. The grid is arbitrarily filled with Arabic numerals 1-16, with a total of 16 digits. During the test, participants were asked to manually click on number locations in order of 1-16, and only after clicking the correct location could they proceed to the next number click. The software automatically records the time spent. Subjects were asked to complete two trials each time, with a short break between each trial, and to record the shortest time to complete the trial between the two tests.
10 secondary outcomes
Patient activity/rest condition
Time frame: 30 minutes after extubation and 24 hours after surgery
The quality of recovery score
Time frame: 24 hours after surgery to complete the QoR-15 score assessment
ramsay sedation score
Time frame: 30min after extubation to complete the ramsay sedation score assessment
Anesthesia adverse events
Time frame: during surgery
drug-related adverse reactions
Time frame: during surgery
Use of vasoactive drugs
Time frame: during surgery
fluid volume
Time frame: during surgery
Record the time of extubation
Time frame: From the end of the surgery to leaving the postoperative recovery room
Numerical rating scale 24 hours after surgery
Time frame: from 24 hours after surgery to complete the NRS pain assessment
Postoperative nausea numerical rating scale
Time frame: from 24 hours after surgery to complete the postoperative nausea NRS score
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2025.
- Individual participant dataSharing planned: Yes
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Remimazolam and propofol in people with Cognitive Functioning and Propofol, run by The Second Affiliated Hospital of Chongqing Medical University 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 1 inclusion and 1 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: opening soon, as of the sponsor's last update on 14 Feb 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact He Huang H Huang (86+13708385559, huanghe@cqmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cognitive function (time frame: 30 minutes after extubation and 24 hours after surgery). The study lists 5 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 14 Feb 2025.