General AnaesthesiaPhase 3NCT03669484
Comparative Clinical Study of Efficacy and Safety of Remimazolam and Propofol in Patients Undergoing Elective Surgery Under General Anaesthesia
A Phase 3 study testing Remimazolam, Propofol and Fentanyl in people with General Anaesthesia, run by R-Pharm at 6 sites in Russia.
Trial summary
The purpose of this study was to perform comparative evaluation of clinical efficacy and safety of Remimazolam and Propofol for induction and maintenance of general anesthesia in patients undergoing elective surgery under general anaesthesia. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- General Anaesthesia
- What is being tested?
- Remimazolam, Propofol and Fentanyl
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 6 sitesRussia
- Study dates
- 22 Aug 2017to 24 May 2018
- Phase
- Phase 3
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed informed consent form to participate in the study prior to initiation of any study-related procedures, and possibility to follow the protocol.
- Body mass index (BMI) calculated as body weight (kg)/height (m)2, ≤ 30 kg/m2.
- Patients hospitalized for elective surgery in whom intraoperative mechanical ventilation using tracheal intubation (oropharyngeal or nasotracheal) is planned.
- Patients for whom the duration of inpatient hospital stay for at least 2 days (1 day before and 1 day after the surgery).
- American Society of Anesthesiologists scale (ASA) I - II functional class.
- For females: negative result of a pregnancy test (urine test using test strips) since the moment of enrollment to the study prior to administration of the test drug/reference drug, as well as consent to use birth control methods throughout the entire study (since the moment of enrollment to the study until the complete ending of the observation period) for women of childbearing potential.
- Female patients who did not have menstrual periods for 2 years or more before enrollment to the study or female patients who underwent a surgical procedure (surgical sterilization, bilateral oophorectomy, hysterectomy etc.) are considered females of no childbearing potential.
- For males: consent to use birth control methods throughout the entire study (since the moment of enrollment to the study until the complete ending of the observation period).
Who cannot join
- Patients in whom local anesthesia is planned (subarachnoid (spinal) block, epidural anesthesia or peripheral nerve block) during the period from admission into an operating room till extubation on Day 1 (administration of the test drug/reference drug).
- Patients in whom organ transplantation is planned.
- Patients in whom heart surgery is planned.
- Patients with uncontrolled hypertension (e.g. systolic blood pressure ≥160 mm Hg while on antihypertensive therapy).
- Patients in whom total bilirubin level ≥ 51 mmol/l or aspartate aminotransferase (AST) or alanin aminotransferase (ALT) level ≥ 2.5 upper limit of normal (ULN) (or ≥100 U/L) during the period from Day -14 till their admission to the operating room.
- Patients in whom serum creatinine level ≥140 mmol/l during the period from Day -14 till their admission to the operating room.
Show all 31Show fewer
- Patients undergoing an urgent surgical procedure.
- Patients in whom a surgical procedure lasting less than 1 hour is planned.
- Patients in whom extubation problems are anticipated due to the expected necessity of prolonged respiratory support using tracheal intubation.
- Patients with history of resistance to benzodiazepines or propofol.
- Patients with history of hypersensitivity to benzodiazepines, propofol, opioid analgesics, fentanyl citrate, rocuronium bromide, sugammadex sodium, flumazenil, naloxone, or other anesthetics or benzodiazepine receptor antagonists.
- Acute open-angle glaucoma.
- Myasthenia gravis or myasthenic syndrome.
- Patients with shock or coma.
- Acute alcohol intoxication.
- Patients with epilepsy.
- Patients with inserted pacemaker with a bioelectric impedance sensor.
- Patients in whom correct evaluation of the bispectral index (BIS) cannot be performed due to a structural brain disorder.
- Patients who received benzodiazepines, in case the period between their discontinuation and the administration of the test drug/reference drug is less than 5 half-lives of benzodiazepine (or 5 half-lives of the active metabolites, if applicable), or in case benzodiazepines are revealed in urine test during the screening.
- Patients taking psychotropic drugs (depot forms should be discontinued at least 1 month prior to the screening; administration of typical forms should be discontinued at least 1 week prior to the screening).
- Patients in whom massive blood loss is expected (e.g. at least 15% of the circulating volume) during the surgery.
- History of severe allergic reactions.
- Alcohol and/or drug abuse or history of such abuse.
- Nursing women.
- Patients in whom any other unregistered drugs (including prescription of unregistered combination products or new pharmaceutical forms during the clinical study) are planned within 120 days prior to administration of the study drugs.
- Patients admitted incapacitated to give an informed consent due to dementia, etc.
- Patients receiving (had a history of receiving) any medicinal product containing the active substance similar to remimazolam.
- Patients with exacerbation of existing mental disorders.
- Patients with a confirmed or suspected malignancy of any localization.
- Detection of viral hepatitis B and C, HIV infection or syphilis based on the results of screening investigations.
- Patients considered not conforming to the objectives of this study for any other reasons by the Principal Investigator or the Investigator.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Russia6 sites
FSBI Central Clinical Hospital and Polyclinic of Adminisatration of the President of the Russian Federation
Moscow
FSBI Russian National Medical and Surgical Center n.a. N.I.Pirogov
Moscow
SBHI City Clinical Hospital №1 n.a. N.I. Pirogov
Moscow
SBHI City Clinical Hospital №64 n.a. V.V. Vinogradov
Moscow
SBHI Institute of Surgery n.a. A.V.Vishevsky
Moscow
SBHI Moscow Clinical Research and Practical center of Department of Healthcare of the city of Moscow
Moscow
About this study
Official title: International Multicenter Single Blind Randomized Clinical Study to Compare Efficacy and Safety of Remimazolam and Propofol in Patients Undergoing Elective Surgical Procedures Under General Anesthesia
The purpose of this study was to perform comparative evaluation of clinical efficacy and safety of Remimazolam and Propofol for induction and maintenance of general anesthesia in patients undergoing elective surgery under general anaesthesia.
Read the detailed description
Only patients with scheduled operations were screened for eligibility in this study. Screening period for each patient lasted from 1 to 14 days. All patients eligible as per protocol criteria were randomized in 1:1 ratio to receive investigational or reference drug. Randomisation was carried out in admission to the operating room - Day1.
For the induction of anesthesia, first there was administration of the trial drug / reference drug, then - administration of a narcotic analgesic (fentanyl at a dose of 2 mg/kg), after which after loss of consciousness, muscle relaxant was used (rocuronium bromide at a dose of 0.6-0.9 mg/kg). Tracheal intubation was performed after achieving the necessary relaxation of the muscles.
Maintenance of anesthesia during surgery was done using the trial drug / reference drug, muscle relaxant (rocuronium bromide - if necessary, during the anesthesia maintenance, the dose was selected individually) and narcotic analgetic (fentanyl, if necessary, during the anesthesia maintenance, the dose was selected individually). To control patient's condition before, during and after surgery, the significant vital parameters were monitored (level of blood pressure and heart rate, respiratory rate, body temperature, saturation, intraoperative ECG, bispectral index (BIS)).
After the operation patients were transferred to the postoperation room where the assessment of the operation memory, and possible presence of postoperative delirium was performed as well as on Day 2. Further treatment and determination of compliance of patient's condition with the criteria for discharge from the hospital was carried out in accordance with current practice of the center.
In 7 (± 2) days after the end of trial drugs administration, patient's condition monitoring and safety evaluation were carried out through telephone contact with the patient, during which data on adverse events and concomitant therapy were collected. Scheduled trial duration for each patient was a maximum of 24 days.
Therapy was considered ineffective, if other sedatives were required for induction (loss of consciousness was not registered after study drugs dose adjustment) and/or maintenance of the required level of sedation during anesthesia (in case of signs of awakening appeared and remained after study drugs dose adjustment).
Therapy efficacy evaluation was based on primary and secondary efficacy criteria. Effect of general anesthetic, a combined evaluation criterion consisted of the following criteria. The trial drug/reference drug was regarded effective in patients who had not had any of the below criteria and ineffective in patients who had at least one of the below criteria:
- Intraoperative awakening / preservation of memories of operations;
- The need for additional sedation.
- Conditions
- General Anaesthesia
- Keywords
- anaesthesia, surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RemimazolamDrug
Lyophilisate for preparation of solution for intravenous administration, 50 mg. Required to prepare a 50 ml syringe with the infusion solution at a concentration of 1 mg/ml (in accordance with guidance given in protocol)
PropofolDrug
Also called Diprivan®
Emulsion for infusion, 10 mg/mL in 20-mL glass vials
FentanylDrug
Solution for intravenous administration, 50 mg/mL. Used for anesthesia induction (at a dose of 2 mg/kg) and, if necessary, anesthesia maintenance (the dose was selected individually)
Rocuronium bromideDrug
Solution for intravenous administration, 10 mg/mL. Used for anesthesia induction (at a dose of 0.6-0.9 mg/kg) and, if necessary, anesthesia maintenance (the dose was selected individually)
| Study group | Role | What they receive |
|---|---|---|
| Remimazolam | Experimental | The induction of anesthesia: intravenous infusion of 6 mg/kg/h until registration of loss of consciousness.
Maintenance of anesthesia: Remimazolam intravenous infusion initiated at a dose of 1 mg/kg/h; the dose level was adjusted accordingly based on a systemic patient monitoring until the end of operation to 2 mg/kg/h maximum; In case of loss of consciousness was not registered in 2.5 minutes of continuous intravenous infusion: drug administration was terminated. If loss of consciousness was not registered during 30 seconds, other sedative drugs were used for induction and maintenance of anesthesia.
In case of signs of awakening (fluctuation of blood pressure/heart rate, lacrimation, sweating, etc.) were observed: intravenous bolus infusion (maximum level of 12 mg/kg/h for 1 minute). If signs of awakening remained remimazolam administration was discontinued and other sedatives were used. Receives: Drug: Remimazolam; Drug: Fentanyl; Drug: Rocuronium bromide |
| Propofol | Active comparator | The induction of anesthesia: intravenous infusion of 1.5-2.5 mg/kg for about 1 minute.
Maintenance of anesthesia: intravenous infusion for a total dose of 4-12 mg/kg/h; the dose level was adjusted accordingly based on a systemic patient monitoring until the end of operation.
In case of loss of consciousness was not registered other sedative drugs were used for induction and maintenance of anesthesia.
In case of signs of awakening (fluctuation of blood pressure/heart rate, lacrimation, sweating, etc.) were observed and propofol dose adjustment had not resulted in the desired effect and signs of awakening were saved: the use of propofol was discontinued and other sedatives were used. Receives: Drug: Propofol; Drug: Fentanyl; Drug: Rocuronium bromide |
What is being measured
The primary outcome is the main question the study is designed to answer.
ANAESTassessment
"Action as a general anesthetic", a compound evaluation criterion, consisted of the following criteria. The test drug/comparator were considered effective in patients who had not had any of the following criteria and ineffective in patients who had at least one of the following criteria:
- Intraoperative awakening/preservation of memories of surgery;
- The need for additional sedatives.
Measured: During the surgery and 24 hours after the study drugs administration
Secondary outcomes (7)
TIMEextub
Extubation time (minutes)
Measured: From the moment of discontinuation of the test drug / comparator to restoration of spontaneous breathing and removal of the endotracheal tube on Day 1 of treatment
TIMEopeneyes
Time of eyes opening (minutes). A patient was often asked with a normal voice to open his/her eyes. The time to spontaneous eye opening was recorded.
Measured: From the moment of discontinuation of the test drug / comparator to eye opening on Day 1 of treatment
TIMEunconsc
Time of unconsciousness
Measured: From the onset of administration of the test drug/comparator to unconsciousness on Day 1 of treatment
Bispectral index value (BISx)
Bispectral index calculation was carried out automatically by the hardware monitor on electrical activity of the brain and could range from 0 (no electrical activity of the brain) to 100 (clear conscience)
Measured: Every 5 minutes from admission of a patient to the operating room until transfer from the operating room on Day 1 of treatment
TIMEDOB
Date of birth memory
Measured: From the end of administration of the test drug/comparator to the time when the patient will be able to say the date of his/her birth on Day 1 and 2 of treatment
TIMEORleave
Operation room leaving time - the time when a patient's condition meets the criteria for transfer from the operating room
Measured: From the end of administration of the test drug/comparator to the time when the patient is transferred from the operating room on Day 1 of treatment
TIMErecuper
Total recovery time assessed by the modified Aldrete scale - a commonly used scale (0-10 points) for determining when patients can be safely discharged from the post-anesthesia care unit assessing patient's activity, respiration, circulation, consciousness and oxygen saturation.
Measured: From the end of administration of the study drug/comparator until the patient reaches the modified Aldrete's system score of ≥9 points on Day 1 of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2018
- Study start22 Aug 2017
- Primary completion15 May 2018
- Study completion24 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for General AnaesthesiaStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- R-Pharm
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Synergy Research Inc.
- Responsible party
- Sponsor
- Investigators
- Mikhail Samsonov, Study director, R-Pharm
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03669484
- Sponsor's protocol ID
- CN01082020
- Status last verified
- Sep 2018
- First submitted
- 7 Sep 2018
- Last updated
- 13 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- International Multicenter Single Blind Randomized Clinical Study to Compare Efficacy and Safety of Remimazolam and Propofol in Patients Undergoing Elective Surgical Procedures Under General Anesthesia
- ClinicalTrials.gov ID
- NCT03669484
- Acronym / sponsor ID
- CN01082020
- Conditions
- General Anaesthesia
- Keywords
- anaesthesia, surgery
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- R-PharmIndustry (pharma, biotech, devices)
- Collaborators
- Synergy Research Inc.
- Study start
- 22 Aug 2017 (actual)
- Primary completion
- 15 May 2018 (actual)
- Study completion
- 24 May 2018 (actual)
- First posted
- 13 Sep 2018 (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.
The purpose of this study was to perform comparative evaluation of clinical efficacy and safety of Remimazolam and Propofol for induction and maintenance of general anesthesia in patients undergoing elective surgery under general anaesthesia.
Detailed description
Only patients with scheduled operations were screened for eligibility in this study. Screening period for each patient lasted from 1 to 14 days. All patients eligible as per protocol criteria were randomized in 1:1 ratio to receive investigational or reference drug. Randomisation was carried out in admission to the operating room - Day1.
For the induction of anesthesia, first there was administration of the trial drug / reference drug, then - administration of a narcotic analgesic (fentanyl at a dose of 2 mg/kg), after which after loss of consciousness, muscle relaxant was used (rocuronium bromide at a dose of 0.6-0.9 mg/kg). Tracheal intubation was performed after achieving the necessary relaxation of the muscles.
Maintenance of anesthesia during surgery was done using the trial drug / reference drug, muscle relaxant (rocuronium bromide - if necessary, during the anesthesia maintenance, the dose was selected individually) and narcotic analgetic (fentanyl, if necessary, during the anesthesia maintenance, the dose was selected individually). To control patient's condition before, during and after surgery, the significant vital parameters were monitored (level of blood pressure and heart rate, respiratory rate, body temperature, saturation, intraoperative ECG, bispectral index (BIS)).
After the operation patients were transferred to the postoperation room where the assessment of the operation memory, and possible presence of postoperative delirium was performed as well as on Day 2. Further treatment and determination of compliance of patient's condition with the criteria for discharge from the hospital was carried out in accordance with current practice of the center.
In 7 (± 2) days after the end of trial drugs administration, patient's condition monitoring and safety evaluation were carried out through telephone contact with the patient, during which data on adverse events and concomitant therapy were collected. Scheduled trial duration for each patient was a maximum of 24 days.
Therapy was considered ineffective, if other sedatives were required for induction (loss of consciousness was not registered after study drugs dose adjustment) and/or maintenance of the required level of sedation during anesthesia (in case of signs of awakening appeared and remained after study drugs dose adjustment).
Therapy efficacy evaluation was based on primary and secondary efficacy criteria. Effect of general anesthetic, a combined evaluation criterion consisted of the following criteria. The trial drug/reference drug was regarded effective in patients who had not had any of the below criteria and ineffective in patients who had at least one of the below criteria:
- Intraoperative awakening / preservation of memories of operations;
- The need for additional sedation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Remimazolam | Experimental | Drug: Remimazolam, Drug: Fentanyl, Drug: Rocuronium bromideThe induction of anesthesia: intravenous infusion of 6 mg/kg/h until registration of loss of consciousness. Maintenance of anesthesia: Remimazolam intravenous infusion initiated at a dose of 1 mg/kg/h; the dose level was adjusted accordingly based on a systemic patient monitoring until the end of operation to 2 mg/kg/h maximum; In case of loss of consciousness was not registered in 2.5 minutes of continuous intravenous infusion: drug administration was terminated. If loss of consciousness was not registered during 30 seconds, other sedative drugs were used for induction and maintenance of anesthesia. In case of signs of awakening (fluctuation of blood pressure/heart rate, lacrimation, sweating, etc.) were observed: intravenous bolus infusion (maximum level of 12 mg/kg/h for 1 minute). If signs of awakening remained remimazolam administration was discontinued and other sedatives were used. |
| Propofol | Active comparator | Drug: Propofol, Drug: Fentanyl, Drug: Rocuronium bromideThe induction of anesthesia: intravenous infusion of 1.5-2.5 mg/kg for about 1 minute. Maintenance of anesthesia: intravenous infusion for a total dose of 4-12 mg/kg/h; the dose level was adjusted accordingly based on a systemic patient monitoring until the end of operation. In case of loss of consciousness was not registered other sedative drugs were used for induction and maintenance of anesthesia. In case of signs of awakening (fluctuation of blood pressure/heart rate, lacrimation, sweating, etc.) were observed and propofol dose adjustment had not resulted in the desired effect and signs of awakening were saved: the use of propofol was discontinued and other sedatives were used. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Signed informed consent form to participate in the study prior to initiation of any study-related procedures, and possibility to follow the protocol.
- Body mass index (BMI) calculated as body weight (kg)/height (m)2, ≤ 30 kg/m2.
- Patients hospitalized for elective surgery in whom intraoperative mechanical ventilation using tracheal intubation (oropharyngeal or nasotracheal) is planned.
- Patients for whom the duration of inpatient hospital stay for at least 2 days (1 day before and 1 day after the surgery).
- American Society of Anesthesiologists scale (ASA) I - II functional class.
Key exclusion criteria (31 listed)
- Patients in whom local anesthesia is planned (subarachnoid (spinal) block, epidural anesthesia or peripheral nerve block) during the period from admission into an operating room till extubation on Day 1 (administration of the test drug/reference drug).
- Patients in whom organ transplantation is planned.
- Patients in whom heart surgery is planned.
- Patients with uncontrolled hypertension (e.g. systolic blood pressure ≥160 mm Hg while on antihypertensive therapy).
- Patients in whom total bilirubin level ≥ 51 mmol/l or aspartate aminotransferase (AST) or alanin aminotransferase (ALT) level ≥ 2.5 upper limit of normal (ULN) (or ≥100 U/L) during the period from Day -14 till their admission to the operating room.
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 |
|---|---|---|
| RemimazolamLyophilisate for preparation of solution for intravenous administration, 50 mg. Required to prepare a 50 ml syringe with the infusion solution at a concentration of 1 mg/ml (in accordance with guidance given in protocol) | Drug | Remimazolam |
| PropofolAlso: Diprivan®Emulsion for infusion, 10 mg/mL in 20-mL glass vials | Drug | Propofol |
| FentanylSolution for intravenous administration, 50 mg/mL. Used for anesthesia induction (at a dose of 2 mg/kg) and, if necessary, anesthesia maintenance (the dose was selected individually) | Drug | Propofol, Remimazolam |
| Rocuronium bromideSolution for intravenous administration, 10 mg/mL. Used for anesthesia induction (at a dose of 0.6-0.9 mg/kg) and, if necessary, anesthesia maintenance (the dose was selected individually) | Drug | Propofol, Remimazolam |
Primary outcome
ANAESTassessment
Time frame: During the surgery and 24 hours after the study drugs administration
"Action as a general anesthetic", a compound evaluation criterion, consisted of the following criteria. The test drug/comparator were considered effective in patients who had not had any of the following criteria and ineffective in patients who had at least one of the following criteria: 1. Intraoperative awakening/preservation of memories of surgery; 2. The need for additional sedatives.
7 secondary outcomes
TIMEextub
Time frame: From the moment of discontinuation of the test drug / comparator to restoration of spontaneous breathing and removal of the endotracheal tube on Day 1 of treatment
TIMEopeneyes
Time frame: From the moment of discontinuation of the test drug / comparator to eye opening on Day 1 of treatment
TIMEunconsc
Time frame: From the onset of administration of the test drug/comparator to unconsciousness on Day 1 of treatment
Bispectral index value (BISx)
Time frame: Every 5 minutes from admission of a patient to the operating room until transfer from the operating room on Day 1 of treatment
TIMEDOB
Time frame: From the end of administration of the test drug/comparator to the time when the patient will be able to say the date of his/her birth on Day 1 and 2 of treatment
TIMEORleave
Time frame: From the end of administration of the test drug/comparator to the time when the patient is transferred from the operating room on Day 1 of treatment
TIMErecuper
Time frame: From the end of administration of the study drug/comparator until the patient reaches the modified Aldrete's system score of ≥9 points on Day 1 of treatment
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 13 Sep 2018.
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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.
Mikhail Samsonov study director
R-Pharm
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Remimazolam, Propofol and Fentanyl in people with General Anaesthesia, run by R-Pharm at 6 sites 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 8 inclusion and 31 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 13 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
ANAESTassessment (time frame: During the surgery and 24 hours after the study drugs administration). 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 13 Sep 2018.