Chronic Renal FailurePhase 3NCT01837290
Effects of Dexmedetomidine Premedication on Geriatric Patients With Chronic Renal Failure Undergoing Hip Surgery
A Phase 3 study testing dexmedetomidine infusion for premedication, Midazolam and saline infusion in people with Chronic Renal Failure and Hip Fracture, run by Baskent University at 3 sites in Turkey (Türkiye).
Trial summary
Geriatric patients (age ≥ 65 years) undergo surgery for hip fractures that develops due to osteoporosis and falls. Dialysis-dependent chronic kidney disease is associated with an increased risk of cardiovascular comorbidity. Read more about this study
- Who is it for?
- Ages 65 to 95 years
- Conditions the study is for
- Chronic Renal Failure, Hip Fracture
- What is being tested?
- dexmedetomidine infusion for premedication, Midazolam and saline infusion
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 3 sitesTurkey (Türkiye)
- Study dates
- Dec 2012to Jan 2014
- 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 65 to 95 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- elderly patients (above 65 years of age)
- end stage renal failure on dialysis treatment (Glomerular filtration rate <15, Stage 5)
- hip fracture
Who cannot join
- Patients with decompensated respiratory or heart failure,
- liver failure
- morbid obesity
- mental disorders
- cognitive disorders
- language problems
- patients with a contraindication for regional anesthesia (coagulopathy, history of anticoagulant use, spinal cord disease and patients who rejected spinal anesthesia)
Trial locations and contacts
3 sites in 1 country.
Turkey (Türkiye)3 sites
Baskent University School of Medicine Adana Research and Teaching Center
Adana, 01250
Baskent University School of Medicine Adana Teaching and Research Center
Adana, 01250
Baskent University School of Medicine Adana Teaching and Research Hospital
Adana, 01250
About this study
Official title: The Effect of Dexmedetomine Premedication on the Bispectral Index Values Using Sedation With Propofol During Spinal Anesthesia on Geriatric Chronic Renal Failure Patients Undergoing Hip Fracture Surgery The Effect of Dexmedetomine Premedication on the Bispectral Index Values Using Sedation With Propofol During Spinal Anesthesia on Geriatric Chronic Renal Failure Patients Undergoing Hip Fracture Surgery
Geriatric patients (age ≥ 65 years) undergo surgery for hip fractures that develops due to osteoporosis and falls. Dialysis-dependent chronic kidney disease is associated with an increased risk of cardiovascular comorbidity. Elective or urgent surgical operations may be required for geriatric patients with end stage renal disease. These patients have severe comorbidities, fluid, electrolyte disturbances and drug metabolism abnormalities during the perioperative period. For this reasons a careful anesthesia plan should be planned and performed. Spinal anesthesia can be used for hip fracture surgery at geriatric patients with chronic renal failure. Anterograde femoral intramedullary nailing can be performed in supine position with a fracture table. Intraoperative sedation might be necessary for patients under regional anesthesia on traction table. Dexmedetomidine is an alpha 2 receptor agonist that is being used as an agent for its sedative and adjuvant analgesic effects.
The aim of this study is to evaluate the effects of dexmedetomidine premedication on geriatric patients with end stage renal disease, who will be undergoing a surgical operation for hip fracture under spinal anesthesia with hyperbaric bupivacaine and BIS (Bispectral Index) guided sedation with intraoperative propofol infusion.
Read the detailed description
Patients will be randomized into two separate groups.Group Dexmedetomidine (Group D): Midazolam 0.02 mg/kg + 0.5 μg/kg/10 min dexmedetomidine infusion for premedication; Spinal block (Hyperbaric bupivacaine 0.5% 12.5 mg) (n=30) Group Control (Group C): Midazolam 0.02 mg/kg + saline infusion for premedication; Spinal block (Hyperbaric bupivacaine 0.5% 12.5mg) (n=30)
In this randomized double-blinded study, drugs will be prepared by an anesthesia technician who is not part of the study. The patients will be monitored with a pulse-oxymeter, 5-channel ECG, noninvasive blood pressure and BIS at the preoperative preparation room. BIS monitoring electrodes will be placed on the forehead of the patient. Study drugs will be administered to the patient by another anesthesiologist who is also not taking part in the study at the preparation room preoperatively. Dexmedetomidine (0.5 μg/kg) in 20 ml saline will be administered in 10 minutes, with an infusion pump. An equivalent volume of saline solution will be given to the control group with same method. Baseline, 1., 3., 5., 10., minute BIS SpO2, systolic, diastolic and mean arteriel pressure values will be recorded. At this period 500 ml of 0.9% NaCl will be infused. The patient will then be transported to the operating room with the supervision of this anesthesiologist. The intraoperative and postoperative follow-up of the patients will be performed by another anesthesiologist who has been blinded to the study drugs as well as the group distribution. Routine anesthesia monitoring will be performed with pulse-oxymeter, 5-lead ECG, noninvasive blood pressure measurement, pulse oxymetry and BIS. Before induction of the spinal block basal systolic, diastolic and mean blood pressures, heart rate, peripheral oxygen saturation and BIS values will be recorded. Lumbar puncture will be performed in lateral decubitis position with a Quincke 27 gauge spinal needle at the L3-L4 interspaces using the midline approach. Patients will be promptly rotated supine position after block induction. Induction of the spinal block will be accepted as 0 for all intraoperative data recordings. Systolic, diastolic and mean blood pressures, heart rate, peripheral oxygen saturation and BIS values will be recorded at 1.,3. 5. minutes and every 5 minutes for the first hour and following that every 15 minutes during surgery.
Hypotension will be described as a drop off in systolic pressure by greater then 25% from the baseline or in case systolic blood pressure decreases below 90 mm Hg, 5 mg ephedrine will be administered intravenously and the rate of crystalloid infusion will be increased.
The sensorial block level and the motor block level will be tested with the pinprick test and Bromage scale (Bromage Scale; 0: No motor block: full flexion of knee and foot, 1: Inability to raise extended leg. Just able to move knee, 2: Inability to flex knee. Able to move foot only, 3: Inability to flex ankle joint. Unable to move foot or knee), respectively. Propofol infusion will be started in all patients at a dose of 50 mcg/kg/min after the level of block arises to T10 dermatome level. Target BIS values will be between 70 and 80. Infusion rate will be titrate to provide the targeted BIS levels.The time when BIS < 80 will be recorded. In case BIS<70, propofol infusion rate will be reduced. ''Observer's assessment of alertness/sedation (OAA/S)'' scale (OAAS score 5-awake and responds readily to name spoken in normal tone, OAAS score 4-lethargic responses to name in normal tone, OAAS score 3-responds only after name is called loudly and/or repeatedly, OAAS score 2-responds only after name called loudly and mild shaking, OAAS score 1-does not respond when name is called loudly and mild shaking or prodding, OAAS score 0-does not respond to noxious stimulation) will be used for evaluating the level of sedation, with a target of OAA/S ≤ 5. OAA/S scores will be registered at the same time points. Propofol infusion will be ended at the beginning of skin suturing, and BIS>90 time will be recorded.
Patients will be monitored at the postoperative care unit and all monitoring parameters (MAP, SAP, DAP, BIS, OASS) will be registered at every 5 minutes for one hour. Criteria for transferring the ward are BIS>90, OAA/S=5, Bromage=0-1 Duration of the surgery, the amount of bleeding, vasoactive drug need, the time necessary to reach the targeted level of sedation (BIS≤80), the amount of propofol infusion, propofol dose required for targeted BIS levels and the total propofol consumption recovery time (BIS>90) first analgesic requirement time (VAS: Visual Analogue Scale;0=no pain, 10=worst pain possible,VAS≥3) and the complications will be recorded. Side effects and possible complications during the intraoperative period and the postoperative follow-up include: hypotension (SBP<90 mmHg), bradycardia (CR < 60/min), hypoxia (SpO2≤ 94 %), nausea, vomiting, and respiratory depression will be recorded and the necessary medical interventions will be administered.
- Conditions
- Chronic Renal Failure, Hip Fracture
- Being tested
- dexmedetomidine infusion for premedication, Midazolam, saline infusion, Spinal block with hyperbaric bupivacaine 0.5% 12.5 mg
- Keywords
- Renal failure,, hip fracture,, spinal anesthesia,, dexmedetomidine, patient
- Medical subject headings
- Kidney Failure, Chronic, Hip Fractures, Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dexmedetomidine infusion for premedicationDrug
Also called Precedex 200mcg/2ml, 121/87, Hospira İnc., Rocky Mount, NC 27801 USA
Group Dexmedetomidine (Group D): Midazolam 0.02 mg/kg + 0.5 μg/kg/10 min dexmedetomidine infusion for premedication; Spinal block (Hyperbaric bupivacaine 0.5% 12.5 mg) (n=30)
MidazolamDrug
Also called Demizolam, Dem İlaç San. ve Tic AŞ.
intravenous Midazolam 0.02 mg/kg for premedication
saline infusionDrug
Also called 0.9% sodium chloride solution
Saline infusion to facilitate blinding
Spinal block with hyperbaric bupivacaine 0.5% 12.5 mgDrug
Also called Marcaine Spinal Heavy 0.5%, Astra Zeneca, 21.01.2000-194/86
Hyperbaric bupivacaine injection for spinal block
| Study group | Role | What they receive |
|---|---|---|
| Group Dexmedetomidine (Group D) | Active comparator | Midazolam 0.02 mg/kg intravenously + 0.5 μg/kg/10 min dexmedetomidine infusion for premedication + Spinal block (Hyperbaric bupivacaine 0.5% 12.5 mg) (n=30) Receives: Drug: dexmedetomidine infusion for premedication; Drug: Midazolam; Drug: Spinal block with hyperbaric bupivacaine 0.5% 12.5 mg |
| Group Control (Group C) | Placebo comparator | Midazolam 0.02 mg/kg + saline infusion for premedication; Spinal block (Hyperbaric bupivacaine 0.5% 12.5mg) (n=30) Receives: Drug: Midazolam; Drug: saline infusion; Drug: Spinal block with hyperbaric bupivacaine 0.5% 12.5 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Decrease at the propofol doses and postoperative early recovery
In addition patients will be followed postoperatively first 6 hours for postoperative pain management at the ward.
Measured: up to first 6 hours for postoperative pain management
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2013 (estimated)
- Study startDec 2012
- Primary completionJan 2014
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Chronic Renal FailureStudies 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baskent University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pinar Ergenoglu, Baskent University
- Investigators
- Anis Aribogan, Prof., MD, Study director, Baskent University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01837290
- Sponsor's protocol ID
- KA12/166
- Status last verified
- Jan 2015
- First submitted
- 17 Apr 2013
- Last updated
- 27 Jan 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Ozkan-Seyhan T, Sungur MO, Senturk E, Karadeniz M, Basel A, Senturk M, Akpir K. BIS guided sedation with propofol during spinal anaesthesia: influence of anaesthetic level on sedation requirement. Br J Anaesth. 2006 May;96(5):645-9. doi: 10.1093/bja/ael055. Epub 2006 Mar 10.
PubMed 16531442Ergenoglu P, Akin S, Bali C, Eker HE, Yalcin Cok O, Aribogan A. Effect of low dose dexmedetomidine premedication on propofol consumption in geriatric end stage renal disease patients. Braz J Anesthesiol. 2015 Sep-Oct;65(5):326-32. doi: 10.1016/j.bjane.2014.11.002. Epub 2015 May 2.
PubMed 26323728
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Dexmedetomine Premedication on the Bispectral Index Values Using Sedation With Propofol During Spinal Anesthesia on Geriatric Chronic Renal Failure Patients Undergoing Hip Fracture Surgery The Effect of Dexmedetomine Premedication on the Bispectral Index Values Using Sedation With Propofol During Spinal Anesthesia on Geriatric Chronic Renal Failure Patients Undergoing Hip Fracture Surgery
- ClinicalTrials.gov ID
- NCT01837290
- Acronym / sponsor ID
- KA12/166
- Conditions
- Chronic Renal Failure, Hip Fracture
- Keywords
- Renal failure,, hip fracture,, spinal anesthesia,, dexmedetomidine, patient
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Baskent UniversityUniversity, hospital or other
- Study start
- Dec 2012
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 23 Apr 2013 (estimated)
- 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.
Geriatric patients (age ≥ 65 years) undergo surgery for hip fractures that develops due to osteoporosis and falls. Dialysis-dependent chronic kidney disease is associated with an increased risk of cardiovascular comorbidity. Elective or urgent surgical operations may be required for geriatric patients with end stage renal disease. These patients have severe comorbidities, fluid, electrolyte disturbances and drug metabolism abnormalities during the perioperative period. For this reasons a careful anesthesia plan should be planned and performed. Spinal anesthesia can be used for hip fracture surgery at geriatric patients with chronic renal failure. Anterograde femoral intramedullary nailing can be performed in supine position with a fracture table. Intraoperative sedation might be necessary for patients under regional anesthesia on traction table. Dexmedetomidine is an alpha 2 receptor agonist that is being used as an agent for its sedative and adjuvant analgesic effects.
The aim of this study is to evaluate the effects of dexmedetomidine premedication on geriatric patients with end stage renal disease, who will be undergoing a surgical operation for hip fracture under spinal anesthesia with hyperbaric bupivacaine and BIS (Bispectral Index) guided sedation with intraoperative propofol infusion.
Detailed description
Patients will be randomized into two separate groups.Group Dexmedetomidine (Group D): Midazolam 0.02 mg/kg + 0.5 μg/kg/10 min dexmedetomidine infusion for premedication; Spinal block (Hyperbaric bupivacaine 0.5% 12.5 mg) (n=30) Group Control (Group C): Midazolam 0.02 mg/kg + saline infusion for premedication; Spinal block (Hyperbaric bupivacaine 0.5% 12.5mg) (n=30)
In this randomized double-blinded study, drugs will be prepared by an anesthesia technician who is not part of the study. The patients will be monitored with a pulse-oxymeter, 5-channel ECG, noninvasive blood pressure and BIS at the preoperative preparation room. BIS monitoring electrodes will be placed on the forehead of the patient. Study drugs will be administered to the patient by another anesthesiologist who is also not taking part in the study at the preparation room preoperatively. Dexmedetomidine (0.5 μg/kg) in 20 ml saline will be administered in 10 minutes, with an infusion pump. An equivalent volume of saline solution will be given to the control group with same method. Baseline, 1., 3., 5., 10., minute BIS SpO2, systolic, diastolic and mean arteriel pressure values will be recorded. At this period 500 ml of 0.9% NaCl will be infused. The patient will then be transported to the operating room with the supervision of this anesthesiologist. The intraoperative and postoperative follow-up of the patients will be performed by another anesthesiologist who has been blinded to the study drugs as well as the group distribution. Routine anesthesia monitoring will be performed with pulse-oxymeter, 5-lead ECG, noninvasive blood pressure measurement, pulse oxymetry and BIS. Before induction of the spinal block basal systolic, diastolic and mean blood pressures, heart rate, peripheral oxygen saturation and BIS values will be recorded. Lumbar puncture will be performed in lateral decubitis position with a Quincke 27 gauge spinal needle at the L3-L4 interspaces using the midline approach. Patients will be promptly rotated supine position after block induction. Induction of the spinal block will be accepted as 0 for all intraoperative data recordings. Systolic, diastolic and mean blood pressures, heart rate, peripheral oxygen saturation and BIS values will be recorded at 1.,3. 5. minutes and every 5 minutes for the first hour and following that every 15 minutes during surgery.
Hypotension will be described as a drop off in systolic pressure by greater then 25% from the baseline or in case systolic blood pressure decreases below 90 mm Hg, 5 mg ephedrine will be administered intravenously and the rate of crystalloid infusion will be increased.
The sensorial block level and the motor block level will be tested with the pinprick test and Bromage scale (Bromage Scale; 0: No motor block: full flexion of knee and foot, 1: Inability to raise extended leg. Just able to move knee, 2: Inability to flex knee. Able to move foot only, 3: Inability to flex ankle joint. Unable to move foot or knee), respectively. Propofol infusion will be started in all patients at a dose of 50 mcg/kg/min after the level of block arises to T10 dermatome level. Target BIS values will be between 70 and 80. Infusion rate will be titrate to provide the targeted BIS levels.The time when BIS < 80 will be recorded. In case BIS<70, propofol infusion rate will be reduced. ''Observer's assessment of alertness/sedation (OAA/S)'' scale (OAAS score 5-awake and responds readily to name spoken in normal tone, OAAS score 4-lethargic responses to name in normal tone, OAAS score 3-responds only after name is called loudly and/or repeatedly, OAAS score 2-responds only after name called loudly and mild shaking, OAAS score 1-does not respond when name is called loudly and mild shaking or prodding, OAAS score 0-does not respond to noxious stimulation) will be used for evaluating the level of sedation, with a target of OAA/S ≤ 5. OAA/S scores will be registered at the same time points. Propofol infusion will be ended at the beginning of skin suturing, and BIS>90 time will be recorded.
Patients will be monitored at the postoperative care unit and all monitoring parameters (MAP, SAP, DAP, BIS, OASS) will be registered at every 5 minutes for one hour. Criteria for transferring the ward are BIS>90, OAA/S=5, Bromage=0-1 Duration of the surgery, the amount of bleeding, vasoactive drug need, the time necessary to reach the targeted level of sedation (BIS≤80), the amount of propofol infusion, propofol dose required for targeted BIS levels and the total propofol consumption recovery time (BIS>90) first analgesic requirement time (VAS: Visual Analogue Scale;0=no pain, 10=worst pain possible,VAS≥3) and the complications will be recorded. Side effects and possible complications during the intraoperative period and the postoperative follow-up include: hypotension (SBP<90 mmHg), bradycardia (CR < 60/min), hypoxia (SpO2≤ 94 %), nausea, vomiting, and respiratory depression will be recorded and the necessary medical interventions will be administered.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group Dexmedetomidine (Group D) | Active comparator | Drug: dexmedetomidine infusion for premedication, Drug: Midazolam, Drug: Spinal block with hyperbaric bupivacaine 0.5% 12.5 mgMidazolam 0.02 mg/kg intravenously + 0.5 μg/kg/10 min dexmedetomidine infusion for premedication + Spinal block (Hyperbaric bupivacaine 0.5% 12.5 mg) (n=30) |
| Group Control (Group C) | Placebo comparator | Drug: Midazolam, Drug: saline infusion, Drug: Spinal block with hyperbaric bupivacaine 0.5% 12.5 mgMidazolam 0.02 mg/kg + saline infusion for premedication; Spinal block (Hyperbaric bupivacaine 0.5% 12.5mg) (n=30) |
Who may qualify
- Ages
- 65 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- elderly patients (above 65 years of age)
- end stage renal failure on dialysis treatment (Glomerular filtration rate <15, Stage 5)
- hip fracture
Key exclusion criteria (7 listed)
- Patients with decompensated respiratory or heart failure,
- liver failure
- morbid obesity
- mental disorders
- cognitive disorders
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 |
|---|---|---|
| dexmedetomidine infusion for premedicationAlso: Precedex 200mcg/2ml, 121/87, Hospira İnc., Rocky Mount, NC 27801 USAGroup Dexmedetomidine (Group D): Midazolam 0.02 mg/kg + 0.5 μg/kg/10 min dexmedetomidine infusion for premedication; Spinal block (Hyperbaric bupivacaine 0.5% 12.5 mg) (n=30) | Drug | Group Dexmedetomidine (Group D) |
| MidazolamAlso: Demizolam, Dem İlaç San. ve Tic AŞ.intravenous Midazolam 0.02 mg/kg for premedication | Drug | Group Control (Group C), Group Dexmedetomidine (Group D) |
| saline infusionAlso: 0.9% sodium chloride solutionSaline infusion to facilitate blinding | Drug | Group Control (Group C) |
| Spinal block with hyperbaric bupivacaine 0.5% 12.5 mgAlso: Marcaine Spinal Heavy 0.5%, Astra Zeneca, 21.01.2000-194/86Hyperbaric bupivacaine injection for spinal block | Drug | Group Control (Group C), Group Dexmedetomidine (Group D) |
Primary outcome
Decrease at the propofol doses and postoperative early recovery
Time frame: up to first 6 hours for postoperative pain management
In addition patients will be followed postoperatively first 6 hours for postoperative pain management at the ward.
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 27 Jan 2015.
- Background: PubMed 16531442Ozkan-Seyhan T, Sungur MO, Senturk E, Karadeniz M, Basel A, Senturk M, Akpir K. BIS guided sedation with propofol during spinal anaesthesia: influence of anaesthetic level on sedation requirement. Br J Anaesth. 2006 May;96(5):645-9. doi: 10.1093/bja/ael055. Epub 2006 Mar 10.
- Derived from this study: PubMed 26323728Ergenoglu P, Akin S, Bali C, Eker HE, Yalcin Cok O, Aribogan A. Effect of low dose dexmedetomidine premedication on propofol consumption in geriatric end stage renal disease patients. Braz J Anesthesiol. 2015 Sep-Oct;65(5):326-32. doi: 10.1016/j.bjane.2014.11.002. Epub 2015 May 2.
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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.
Anis Aribogan, Prof., MD study director
Baskent University School of Medicine
3 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 dexmedetomidine infusion for premedication, Midazolam and saline infusion in people with Chronic Renal Failure and Hip Fracture, run by Baskent University at 3 sites in Turkey (Türkiye).
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 3 inclusion and 7 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 27 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Turkey (Türkiye). 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. Some participants in this study may receive a placebo. 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?
Decrease at the propofol doses and postoperative early recovery (time frame: up to first 6 hours for postoperative pain management). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01837290, which also lists 2 linked publications.
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 27 Jan 2015.