Moderate SedationNCT04695509
Sedation and Neuromediators Concentration
A study testing moderate propofol sedation (Bispectral index monitoring 70-90; The Richmond Agitation and Sedation scale (RASS) "-2" - "-3" and deep propofol sedation (BIS 60-70, The Richmond Agitation and Sedation scale (RASS) "-4") in people with Moderate Sedation and Deep Sedation, run by I.M. Sechenov First Moscow State Medical University at 1 site in Russia.
Trial summary
Propofol (Propofol Kabi, Registration number from the State Register of Medicines - 000875) is a widely used intravenous anesthetic. It is well known about different effects of propofol infusion, including euphoria, psycholalia, disinhibition, talkativeness, satisfaction etc. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Moderate Sedation, Deep Sedation
- What is being tested?
- moderate propofol sedation (Bispectral index monitoring 70-90; The Richmond Agitation and Sedation scale (RASS) "-2" - "-3" and deep propofol sedation (BIS 60-70, The Richmond Agitation and Sedation scale (RASS) "-4")
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteRussia
- Study dates
- 5 Oct 2020to 15 Apr 2021
- 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
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Written informed consent
- Age ≥ 18 years
- Elective trauma surgery (arthroscopy, reconstructive foot surgery, osteosynthesis of intra-and periarticular fractures of the proxymal humerus) under regional anesthesia (spinal anesthesia or brachial plexus block) with propofol sedation
- Montreal cognitive assessment test ≥ 26
- Patients with American Society of Anesthesiologists (ASA) I-II
- Non-inclusion criteria:
Show all 16Show fewer
- Not written informed consent
- Age˂18 years
- Allergy to sedation drugs
- Pregnancy
- Epilepsy anamnesis
- II-III degree atrioventricular block
- Montreal cognitive assessment test ˂ 26
- Patients with American Society of Anesthesiologists (ASA) ˃ II
- The presence of psychiatric disorders
- Сancer patients with a life expectancy of less than two years
Who cannot join
- Patient refuse from further participation
- Transition from sedation to general anesthesia
- Allergy on anesthesia drugs during perioperative period
Trial locations and contacts
1 site in 1 country.
Russia1 site
City Clinical Hospital № 31 of the Department of Health of Moscow
Moscow
About this study
Official title: The Influence of Propofol Sedation on Neuromediators Concentration
Propofol (Propofol Kabi, Registration number from the State Register of Medicines - 000875) is a widely used intravenous anesthetic. It is well known about different effects of propofol infusion, including euphoria, psycholalia, disinhibition, talkativeness, satisfaction etc. However, the basic mechanisms of such effects remain unknown. We suppose that propofol sedation with various levels of sedation (from light to deep) leads to neuromediators changes. We examine dopamine, noradrenaline, acetylcholine, GABA and serotonin in peripheral venous blood before, during and after propofol sedation. Therefore, we suppose drugs for sedation, in particular, propofol will affect neuromediators concentration.
Read the detailed description
The study is a prospective, nonrandomized, single center investigator design. Twenty-six healthy patients undergoing elective trauma surgery (arthroscopy, reconstructive foot surgery, osteosynthesis of intra-and periarticular fractures of the proxymal humerus) under regional anesthesia (spinal anesthesia or brachial plexus block) with medical propofol sedation are enrolled in this study. Montreal cognitive assessment test is a high validity test for detecting cognitive impairment before operation. American Society of Anesthesiologists (ASA) physical status classification system is used to assess the physical status of patients before operation. Hospital Anxiety and Depression Scale (HADS) is used to determine the levels of anxiety and depression before operation. Two 18 or 20 G venous cannulae are inserted in the left and/or right forearm for drug infusion and blood sampling. The Richmond Agitation and Sedation scale (RASS) and bispectral index monitor A-2000XP (BIS, Aspect Medical Systems, Inc. (USA), Registration certificate for a medical device RZN 2005/498) are used to determine the levels of sedation. Briefly (less than 10 seconds) awakens with eye contact to voice or any movement (but no eye contact) to voice, bispectral index values 70-90 correspond light-moderate sedation. No response to voice, but any movement to physical stimulation, bispectral index monitoring values 60-70 correspond deep sedation. BBraun Space with target control infusion sedation (TCIS, B. Braun Melsungen AG, Registration certificate for a medical device RZN 2013/905) is used for dosing of propofol with moderate (1-st group) or deep sedation (2-nd group). Philips Monitor IntelliVue MP40 (Medizin Systeme Boblingen GmbH, Germany, Registration certificate for a medical device RZN 2014/2009) is used for monitoring the electrocardiogram (ECG), noninvasive blood pressure (NIBP), pulse oximetry during the infusion of the propofol and 15-20 minutes thereafter. Peripheral venous blood samples are taken for analyzing neuromediators concentration 5 minutes before sedation (10 ml), after 35-40 min of propofol sedation (10 ml) and 10-15 minutes after the end of propofol infusion (emergence from sedation). The blood is centrifuged for at least 8 minutes at 4000 revolutions per minute (RPM) in the test tube 367525-BD VACUTAINER (Becton Dickinson), plasma is taken, which is further frozen at a temperature of -20 C in the test tube 363706-BD MICROTAINER (Becton Dickinson). After 26 patients are recruited, the blood plasma is analyzed by conducting the enzyme-linked immunosorbent assay (ELISA, IBL Hamburg) of neuromediators (dopamine (Catalog № Re59161), serotonin (Catalog № Re59121), gamma-aminobutyric acid (GABA), acetylcholine (Catalog № Re59161), noradrenaline (Catalog № Re59261)). Concentrations of neuromediators between moderate and deep sedation groups are compared using Student's t-test for independent samples. Concentrations of neuromediators before, during and after sedation are compared using Friedman-test for dependent samples. All data is presented as mean ± SD, a value of P less than 0.05 is taken as statistically significant.
- Conditions
- Moderate Sedation, Deep Sedation
- Being tested
- moderate propofol sedation (Bispectral index monitoring 70-90; The Richmond Agitation and Sedation scale (RASS) "-2" - "-3", deep propofol sedation (BIS 60-70, The Richmond Agitation and Sedation scale (RASS) "-4")
- Keywords
- Sedation, Neuromediators
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
moderate propofol sedation (Bispectral index monitoring 70-90; The Richmond Agitation and Sedation scale (RASS) "-2" - "-3"Drug
Two peripheral venous blood catheters are placed after admission in the operation room and venous blood sample is taken (10 ml). Complete monitoring of vital functions is provided (pulse oximetry, noninvasive blood pressure, electrocardiography, bispectral index monitoring). Doctor anesthesiologist performs regional anesthesia and propofol light-moderate sedation starts. The second blood sample (10 ml) is taken 35-40 minutes after the start of propofol sedation. The third blood sample (10 ml) is taken after emergence from propofol sedation (10-15 minutes after propofol discontinuation). Blood samples are centrifuged and received plasma is frozen at a temperature of -20 C*. After 26 patients are recruited, the blood plasma is analyzed by conducting the enzyme-linked immunosorbent assay (ELISA) of neuromediators (Dopamine, serotonin, Gamma-aminobutyric acid (GABA), acetylcholine, noradrenaline).
deep propofol sedation (BIS 60-70, The Richmond Agitation and Sedation scale (RASS) "-4")Drug
Two peripheral venous blood catheter is placed after admission in the operation room and venous blood sample is taken (10 ml). Complete monitoring of vital functions is provided (pulse oximetry, blood pressure, electrocardiography, bispectral index monitoring). Doctor anesthesiologist performs regional anesthesia and propofol deep sedation starts. The second blood sample (10 ml) is taken 35-40 minutes after the start of propofol sedation. The third blood sample (10 ml) is taken after emergence from propofol sedation (10-15 minutes after propofol discontinuation). Blood samples are centrifuged and received plasma is frozen at a temperature of -20 C*. After 26 patients are recruited, the blood plasma is analyzed by conducting enzyme-linked immunosorbent assay (ELISA) of neuromediators (Dopamine, serotonin, Gamma-aminobutyric acid (GABA), acetylcholine, noradrenaline).
| Study group | Role | What they receive |
|---|---|---|
| moderate sedation | Experimental | patients with American Society of Anesthesiologists (ASA) I-II, Montreal cognitive assessment test ≥ 26, trauma surgery under regional anesthesia with moderate propofol sedation Receives: Drug: moderate propofol sedation (Bispectral index monitoring 70-90; The Richmond Agitation and Sedation scale (RASS) "-2" - "-3" |
| deep sedation | Experimental | Arm Description: patients with American Society of Anesthesiologists (ASA I-II), Montreal cognitive assessment test ≥ 26, trauma surgery under regional anesthesia with deep propofol sedation Receives: Drug: deep propofol sedation (BIS 60-70, The Richmond Agitation and Sedation scale (RASS) "-4") |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dopamine concentration changes during moderate and deep sedation
Venous blood sampling and enzyme-linked immunosorbent assay (ELISA) are used to evaluate the influence of medical sedation on dopamine concentration
Measured: 2 months for each patient from venous blood sampling to enzyme-linked immunosorbent assay (ELISA) dopamine conducting
Serotonin concentration changes during moderate and deep sedation
Venous blood sampling and enzyme-linked immunosorbent assay (ELISA) are used to evaluate the influence of medical sedation on serotonin concentration
Measured: 2 months for each patient from venous blood sampling to enzyme-linked immunosorbent assay (ELISA) serotonin conducting
GABA concentration changes during moderate and deep sedation
Venous blood sampling and enzyme-linked immunosorbent assay (ELISA) are used to evaluate the influence of medical sedation on GABA concentration
Measured: 2 months for each patient from venous blood sampling to enzyme-linked immunosorbent assay (ELISA) GABA conducting
Acetylcholine concentration changes during moderate and deep sedation
Venous blood sampling and enzyme-linked immunosorbent assay (ELISA) are used to evaluate the influence of medical sedation on acetylcholine concentration
Measured: 2 months for each patient from venous blood sampling to enzyme-linked immunosorbent assay (ELISA) acetylcholine conducting
Noradrenaline concentration changes during moderate and deep sedation
Venous blood sampling and enzyme-linked immunosorbent assay (ELISA) are used to evaluate the influence of medical sedation on noradrenaline concentration
Measured: 2 months for each patient from venous blood sampling to enzyme-linked immunosorbent assay (ELISA) noradrenaline conducting
Secondary outcomes (3)
Target control infusion (TCI) values of propofol sedation
Bbraun Perfusor Space is used for target control propofol infusion. TCI values for moderate sedation are 1,0-2 mcg/ml, deep sedation 2,5-3,5 mcg/ml.
Measured: intraoperative period
Richmond agitation and sedation scale (RASS) scores
RASS is measured during propofol infusion and the target scores for moderate sedation are "-1" - "-3", deep sedation "-4"
Measured: intraoperative period
Bispectral index monitoring (BIS) values during moderate and deep sedation
BIS-monitor А-2000XP (Aspect Medical Systems, USA) is used for evaluating the level of sedation. BIS values for moderate sedation are 70-90, deep sedation 60-70
Measured: intraoperative period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2021
- Study start5 Oct 2020
- Primary completion15 Jan 2021
- Study completion15 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Moderate SedationStudies 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
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- I.M. Sechenov First Moscow State Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04695509
- Sponsor's protocol ID
- 502
- Status last verified
- Dec 2020
- First submitted
- 18 Dec 2020
- Last updated
- 10 Jun 2021
- 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 10 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Propofol Sedation on Neuromediators Concentration
- ClinicalTrials.gov ID
- NCT04695509
- Acronym / sponsor ID
- 502
- Conditions
- Moderate Sedation, Deep Sedation
- Keywords
- Sedation, Neuromediators
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- I.M. Sechenov First Moscow State Medical UniversityUniversity, hospital or other
- Study start
- 5 Oct 2020 (actual)
- Primary completion
- 15 Jan 2021 (actual)
- Study completion
- 15 Apr 2021 (actual)
- First posted
- 5 Jan 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.
Propofol (Propofol Kabi, Registration number from the State Register of Medicines - 000875) is a widely used intravenous anesthetic. It is well known about different effects of propofol infusion, including euphoria, psycholalia, disinhibition, talkativeness, satisfaction etc. However, the basic mechanisms of such effects remain unknown. We suppose that propofol sedation with various levels of sedation (from light to deep) leads to neuromediators changes. We examine dopamine, noradrenaline, acetylcholine, GABA and serotonin in peripheral venous blood before, during and after propofol sedation. Therefore, we suppose drugs for sedation, in particular, propofol will affect neuromediators concentration.
Detailed description
The study is a prospective, nonrandomized, single center investigator design. Twenty-six healthy patients undergoing elective trauma surgery (arthroscopy, reconstructive foot surgery, osteosynthesis of intra-and periarticular fractures of the proxymal humerus) under regional anesthesia (spinal anesthesia or brachial plexus block) with medical propofol sedation are enrolled in this study. Montreal cognitive assessment test is a high validity test for detecting cognitive impairment before operation. American Society of Anesthesiologists (ASA) physical status classification system is used to assess the physical status of patients before operation. Hospital Anxiety and Depression Scale (HADS) is used to determine the levels of anxiety and depression before operation. Two 18 or 20 G venous cannulae are inserted in the left and/or right forearm for drug infusion and blood sampling. The Richmond Agitation and Sedation scale (RASS) and bispectral index monitor A-2000XP (BIS, Aspect Medical Systems, Inc. (USA), Registration certificate for a medical device RZN 2005/498) are used to determine the levels of sedation. Briefly (less than 10 seconds) awakens with eye contact to voice or any movement (but no eye contact) to voice, bispectral index values 70-90 correspond light-moderate sedation. No response to voice, but any movement to physical stimulation, bispectral index monitoring values 60-70 correspond deep sedation. BBraun Space with target control infusion sedation (TCIS, B. Braun Melsungen AG, Registration certificate for a medical device RZN 2013/905) is used for dosing of propofol with moderate (1-st group) or deep sedation (2-nd group). Philips Monitor IntelliVue MP40 (Medizin Systeme Boblingen GmbH, Germany, Registration certificate for a medical device RZN 2014/2009) is used for monitoring the electrocardiogram (ECG), noninvasive blood pressure (NIBP), pulse oximetry during the infusion of the propofol and 15-20 minutes thereafter. Peripheral venous blood samples are taken for analyzing neuromediators concentration 5 minutes before sedation (10 ml), after 35-40 min of propofol sedation (10 ml) and 10-15 minutes after the end of propofol infusion (emergence from sedation). The blood is centrifuged for at least 8 minutes at 4000 revolutions per minute (RPM) in the test tube 367525-BD VACUTAINER (Becton Dickinson), plasma is taken, which is further frozen at a temperature of -20 C in the test tube 363706-BD MICROTAINER (Becton Dickinson). After 26 patients are recruited, the blood plasma is analyzed by conducting the enzyme-linked immunosorbent assay (ELISA, IBL Hamburg) of neuromediators (dopamine (Catalog № Re59161), serotonin (Catalog № Re59121), gamma-aminobutyric acid (GABA), acetylcholine (Catalog № Re59161), noradrenaline (Catalog № Re59261)). Concentrations of neuromediators between moderate and deep sedation groups are compared using Student's t-test for independent samples. Concentrations of neuromediators before, during and after sedation are compared using Friedman-test for dependent samples. All data is presented as mean ± SD, a value of P less than 0.05 is taken as statistically significant.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| moderate sedation | Experimental | Drug: moderate propofol sedation (Bispectral index monitoring 70-90; The Richmond Agitation and Sedation scale (RASS) "-2" - "-3"patients with American Society of Anesthesiologists (ASA) I-II, Montreal cognitive assessment test ≥ 26, trauma surgery under regional anesthesia with moderate propofol sedation |
| deep sedation | Experimental | Drug: deep propofol sedation (BIS 60-70, The Richmond Agitation and Sedation scale (RASS) "-4")Arm Description: patients with American Society of Anesthesiologists (ASA I-II), Montreal cognitive assessment test ≥ 26, trauma surgery under regional anesthesia with deep propofol sedation |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Written informed consent
- Age ≥ 18 years
- Elective trauma surgery (arthroscopy, reconstructive foot surgery, osteosynthesis of intra-and periarticular fractures of the proxymal humerus) under regional anesthesia (spinal anesthesia or brachial plexus block) with propofol sedation
- Montreal cognitive assessment test ≥ 26
- Patients with American Society of Anesthesiologists (ASA) I-II
Key exclusion criteria (3 listed)
- Patient refuse from further participation
- Transition from sedation to general anesthesia
- Allergy on anesthesia drugs during perioperative period
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 |
|---|---|---|
| moderate propofol sedation (Bispectral index monitoring 70-90; The Richmond Agitation and Sedation scale (RASS) "-2" - "-3"Two peripheral venous blood catheters are placed after admission in the operation room and venous blood sample is taken (10 ml). Complete monitoring of vital functions is provided (pulse oximetry, noninvasive blood pressure, electrocardiography, bispectral index monitoring). Doctor anesthesiologist performs regional anesthesia and propofol light-moderate sedation starts. The second blood sample (10 ml) is taken 35-40 minutes after the start of propofol sedation. The third blood sample (10 ml) is taken after emergence from propofol sedation (10-15 minutes after propofol discontinuation). Blood samples are centrifuged and received plasma is frozen at a temperature of -20 C*. After 26 patients are recruited, the blood plasma is analyzed by conducting the enzyme-linked immunosorbent assay (ELISA) of neuromediators (Dopamine, serotonin, Gamma-aminobutyric acid (GABA), acetylcholine, noradrenaline). | Drug | moderate sedation |
| deep propofol sedation (BIS 60-70, The Richmond Agitation and Sedation scale (RASS) "-4")Two peripheral venous blood catheter is placed after admission in the operation room and venous blood sample is taken (10 ml). Complete monitoring of vital functions is provided (pulse oximetry, blood pressure, electrocardiography, bispectral index monitoring). Doctor anesthesiologist performs regional anesthesia and propofol deep sedation starts. The second blood sample (10 ml) is taken 35-40 minutes after the start of propofol sedation. The third blood sample (10 ml) is taken after emergence from propofol sedation (10-15 minutes after propofol discontinuation). Blood samples are centrifuged and received plasma is frozen at a temperature of -20 C*. After 26 patients are recruited, the blood plasma is analyzed by conducting enzyme-linked immunosorbent assay (ELISA) of neuromediators (Dopamine, serotonin, Gamma-aminobutyric acid (GABA), acetylcholine, noradrenaline). | Drug | deep sedation |
Primary outcome
Dopamine concentration changes during moderate and deep sedation
Time frame: 2 months for each patient from venous blood sampling to enzyme-linked immunosorbent assay (ELISA) dopamine conducting
Venous blood sampling and enzyme-linked immunosorbent assay (ELISA) are used to evaluate the influence of medical sedation on dopamine concentration
Serotonin concentration changes during moderate and deep sedation
Time frame: 2 months for each patient from venous blood sampling to enzyme-linked immunosorbent assay (ELISA) serotonin conducting
Venous blood sampling and enzyme-linked immunosorbent assay (ELISA) are used to evaluate the influence of medical sedation on serotonin concentration
GABA concentration changes during moderate and deep sedation
Time frame: 2 months for each patient from venous blood sampling to enzyme-linked immunosorbent assay (ELISA) GABA conducting
Venous blood sampling and enzyme-linked immunosorbent assay (ELISA) are used to evaluate the influence of medical sedation on GABA concentration
Acetylcholine concentration changes during moderate and deep sedation
Time frame: 2 months for each patient from venous blood sampling to enzyme-linked immunosorbent assay (ELISA) acetylcholine conducting
Venous blood sampling and enzyme-linked immunosorbent assay (ELISA) are used to evaluate the influence of medical sedation on acetylcholine concentration
Noradrenaline concentration changes during moderate and deep sedation
Time frame: 2 months for each patient from venous blood sampling to enzyme-linked immunosorbent assay (ELISA) noradrenaline conducting
Venous blood sampling and enzyme-linked immunosorbent assay (ELISA) are used to evaluate the influence of medical sedation on noradrenaline concentration
3 secondary outcomes
Target control infusion (TCI) values of propofol sedation
Time frame: intraoperative period
Richmond agitation and sedation scale (RASS) scores
Time frame: intraoperative period
Bispectral index monitoring (BIS) values during moderate and deep sedation
Time frame: intraoperative period
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 10 Jun 2021.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing moderate propofol sedation (Bispectral index monitoring 70-90; The Richmond Agitation and Sedation scale (RASS) "-2" - "-3" and deep propofol sedation (BIS 60-70, The Richmond Agitation and Sedation scale (RASS) "-4") in people with Moderate Sedation and Deep Sedation, run by I.M. Sechenov First Moscow State Medical University at 1 site in Russia.
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 16 inclusion and 3 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 10 Jun 2021. 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 Russia. 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?
Dopamine concentration changes during moderate and deep sedation (time frame: 2 months for each patient from venous blood sampling to enzyme-linked immunosorbent assay (ELISA) dopamine conducting). 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 10 Jun 2021.