AnesthesiaPhase 4NCT01017237
Dexmedetomidine Sedation With Third Molar Surgery
A Phase 4 study testing Dexmedetomidine, Midazolam and Ketamine in people with Anesthesia, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial summary
Intravenous sedation is used frequently for the relief of pain and anxiety associated with oral surgical procedures performed under local anesthesia. The purpose of this study is to learn about patient and surgeon satisfaction with sedation using Dexmedetomidine in combination with midazolam alone or with midazolam… Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Anesthesia
- What is being tested?
- Dexmedetomidine, Midazolam and Ketamine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2009to Dec 2011
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- American Society of Anesthesiology (ASA) physical status I and II
- Four asymptomatic third molars indicated for removal
Who cannot join
- Clinical history or ECG evidence of:
- cardiac dysrhythmia or heart block
- ischemic heart disease
- asthma
- sleep apnea
- impaired liver, renal, or mental function
Show all 9Show fewer
- chronic sedative or analgesic use
- allergies to any of the study drugs
- history of pericoronal infection with third molars
Trial locations and contacts
1 site in 1 country.
United States1 site
University of North Carolina School of Dentistry
Chapel Hill, North Carolina, 27599
About this study
Official title: Comparison of the Effectiveness of Sedation With i.v. Dexmedetomidine in Combination With Midazolam Alone or Midazolam and Low Dose Ketamine for Extraction of Third Molars.
Intravenous sedation is used frequently for the relief of pain and anxiety associated with oral surgical procedures performed under local anesthesia. The purpose of this study is to learn about patient and surgeon satisfaction with sedation using Dexmedetomidine in combination with midazolam alone or with midazolam plus low dose ketamine while having wisdom teeth removed.
The sedation produced by dexmedetomidine is unique in that it mimics natural sleep, a unique quality not shared by other drugs. Dexmedetomidine is often used in anesthesia in hospital operating rooms and has been approved by the US Food and Drug Administration for the use planned in this study.
Read the detailed description
Subjects who have been screened medically and are scheduled for third molar surgery in the University of North Carolina (UNC)Oral and Maxillofacial Surgery (OMFS) clinic will be asked to volunteer for the study by the evaluating OMFS resident or attending physician. No additional x-rays will be taken other than those usually indicated for 3rd molar surgery. Informed consent will be obtained by study investigators.
Subjects will be instructed to fast for at least 8 hours prior to their appointment. Surgery will be performed in the Oral \& Maxillofacial Surgery operating/sedation clinic where all monitoring equipment as well as emergency equipment is readily available, including the ability to ventilate the patient with oxygen (bag-mask), the ability to intubate, resuscitation drugs and equipment including a defibrillator. Patients will be positioned in a semi-reclining position in the dental chair and all monitors applied. A 20 gauge i.v. catheter will be placed and normal saline infusion attached. Supplemental oxygen will be administered via nasal cannula at 3 liters per minute. A picture will then be shown for recall testing. Pulse rate, arterial oxygen saturation (SpO2), respiratory rate, blood pressure, end-tidal CO2 (ETCO2), Ramsey Sedation Score (RSS sedation score) and Bispectral Index Scale (BIS) value will be recorded as a baseline and at 5 minute intervals during the procedure. Any SpO2 values below 90% as well as any episodes of apnea greater than 20 seconds will be recorded. Monitoring and recording of all data will be done by one of the investigators. Data will be recorded on pre-printed data forms. The surgical procedure will be performed by an oral and maxillofacial surgery resident physician.
Following the administration of 0.12 mg/kg of dexamethasone , dexmedetomidine will be infused at a rate of 6 mcg/kg/hr for four minutes; resulting in a loading dose of 0.4 mcg/kg. All of the above parameters will again be obtained and recorded. Patients will be randomly assigned by block randomization to receive either midazolam 0.04 mg/kg i.v. (50 patients), or midazolam 0.04 mg/kg plus 0.25 mg/kg of ketamine (50 patients). The operating surgeon and the patient will be blinded as to which protocol is being used. A dexmedetomidine infusion of 0.5 mcg/kg/hr will be initiated and continued until the completion of surgery. At this point local anesthesia will be administered in all four quadrants. Pain reaction during injections will be recorded. When efficacy of local anesthesia has been confirmed, surgery will commence. The surgery will be interrupted at 15 and 30 minutes to show a picture for recall testing by an investigator. If at any point the patient is deemed to be uncomfortable or uncooperative due to inadequate sedation, the protocol will be broken and additional sedation administered as per usual standards. The rescue therapy may include additional midazolam, ketamine, narcotic or propofol at the discretion of the anesthetist/sedationist. At the conclusion of surgery the dexmedetomidine infusion will be discontinued and the patient will be attended by a recovery nurse for collection of postoperative data. During recovery the physiologic parameters will be recorded at 10 minute intervals. When the patient achieves a recovery Aldrete score of >9, they will be asked by an investigator to recall pictures for amnesia assessment, and asked to assess patient satisfaction before leaving with an escort. The patient will be contacted on the day following surgery by phone or e-mail by one of the investigators to test for recall of pictures shown (amnesia testing) and patient satisfaction
- Conditions
- Anesthesia
- Being tested
- Dexmedetomidine, Midazolam, Ketamine
- Keywords
- Dexmedetomidine sedation, Oral surgery sedation, Dexmedetomidine amnesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
Also called Precedex
Dexmedetomidine will be infused at a rate of 6 mcg/kg/hr for four minutes; resulting in a loading dose of 0.4 mcg/kg, Followed by an infusion of 0.5 mcg/kg/hr will be initiated and continued until the completion of surgery.
MidazolamDrug
Also called Versed
Midazolam 0.04 mg/kg i.v. administered after dexmedetomidine loading dose.
KetamineDrug
Also called Ketalar
Ketamine 0.25 mg/ml administered i.v. following the dexmedetomidine loading dose and the midazolam.
| Study group | Role | What they receive |
|---|---|---|
| Dex plus midazolam | Active comparator | Dexmedetomidine loading dose of 0.4 mcg/kg followed by an infusion of 0.5 mcg/kg/hr plus midazolam 0.04 mg/kg i.v. Receives: Drug: Dexmedetomidine; Drug: Midazolam |
| Dex plus midazolam and ketamine | Active comparator | Dexmedetomidine loading dose of 0.4 mcg/kg followed by an infusion of 0.5 mcg/kg/hr plus midazolam 0.04 mg/kg and 0.25 mg/kg ketamine i.v. Receives: Drug: Dexmedetomidine; Drug: Midazolam; Drug: Ketamine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Amnesia: Lack of Picture Recall Shown Prior to Sedation.
Subjects were shown pictures of familiar objects prior to sedation, after the bolus dose of dexmedetomidine was administered, at 15 minutes and 30 minutes into the surgery and at the end of surgery. Subjects were shown a page containing multiple pictures to evaluate whether they could remember any of them. No recall demonstrating the presence of amnesia during that portion of the procedure. This process was repeated the day following surgery
Measured: Day of surgery prior to discharge
Amnesia: Lack of Recall One Day After Surgery of The Picture That Was Shown Prior to Sedation.
Lack of recall of picture shown indicates presence of amnesia the day following surgery.
Measured: One day after surgery
Amnesia: Lack of Picture Recall Following Dexmedetomidine Infusion Plus Midazolam.
Percentage of patients unable to recall picture
Measured: Day of Surgery prior to discharge
Amnesia: Lack of Recall One Day After Surgery of The Picture That Was Shown Following Dexmedetomidine Infusion Plus Midazolam.
Inability to recall picture shown at this time indicates presence of amnesia on the day following surgery.
Measured: One day after surgery
Amnesia: Lack of Picture Recall Shown 15 Minutes Into Surgery
Lack of recall of picture shown at this time indicates presence of amnesia
Measured: Day of Surgery prior to discharge
Amnesia: Lack of Recall One Day After Surgery of The Picture That Was Shown 15 Minutes Into Surgery.
Lack of recall of picture demonstrates presence of amnesia on day following surgery
Measured: One day after surgery
Amnesia: Lack of Picture Recall Shown 30 Minutes Into Surgery
Lack of recall of picture shown indicates presence of amnesia
Measured: Day of Surgery prior to discharge
Primary Title: Amnesia: Lack of Recall One Day After Surgery of The Picture That Was Shown 30 Minutes Into Surgery.
Lack of recall of picture shown indicates presence of amnesia on day following surgery.
Measured: One day after surgery
Amnesia: Lack of Picture Recall at Surgery End Time.
Lack of recall of picture shown indicates presence of amnesia
Measured: Day of surgery prior to discharge
Amnesia: Lack of Recall One Day After Surgery of The Picture That Was Shown at Surgery End Time.
Lack of recall of picture shown indicates presence of amnesia on day following surgery.
Measured: One day after surgery
Secondary outcomes (14)
Respiratory Parameters: Respiratory Rate
Respirations per minute
Measured: Immediately prior to sedation
Respiratory Parameters: Respiratory Rate
Rate of respirations
Measured: During surgical procedure
Respiratory Parameters: Oxyhemoglobin Saturation
Oxyhemoglobin saturation per pule oximeter
Measured: Immediately prior to surgery
Respiratory Parameters: Oxyhemoglobin Saturation
Oxyhemoglobin saturation per pulse oximetry
Measured: During surgical procedure
Respiratory Parameters: End-tidal Carbon Dioxide
Measured via capnography at nares
Measured: Immediately prior to sedation
Respiratory Parameters: End-tidal Carbon Dioxide
Measured by capnography at nares
Measured: Duration of surgery
Mean Arterial Blood Pressure
Blood pressure per automated monitor
Measured: Immediately prior to surgery
Mean Arterial Blood Pressure
Measured using automated blood pressure monitor
Measured: During duration of surgery
Heart Rate
Heart rate per EKG monitor
Measured: Prior to sedation
Heart Rate
Per EKG monitor
Measured: Duration of surgery
Surgeon Satisfaction With Sedation Technique
Numerical value on scale of 1-5 from Very dissatisfied (1) to Extremely satisfied (5)
Measured: After surgery completed: day of surgery, within 15 minutes
Patient Satisfaction With Sedation Technique
Rating of how satisfied the patient was with their sedation on a scale of 1-5 with 1 being very dissatisfied and 5 being extremely satisfied
Measured: after completion of surgery (within 15 minutes)
Ramsey Sedation Scale Score
Rating of depth of sedation by sedationist. Scale 1 - 6, 1 being widw awake and 6 being non-responsive
Measured: During surgical procedure
Bispectral Index Score (BIS)
Bispectral Index (BIS) measures level of consciousness by algorithmic analysis of the patient's electroencephalogram (EEG) during anesthesia and sedation. The BIS can range from 0 (equivalent to EEG silence) to 100 (equivalent to fully awake and alert). A BIS value of 40-60 indicates an adequate general anesthesia state.
Measured: During surgery duration.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2009 (estimated)
- Study startJul 2009
- Primary completionDec 2011
- Study completionDec 2011
Why it stopped: Protocol proved to be ineffective for adequate sedation for third molar surgery.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for AnesthesiaStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jay A Anderson, DDS, MD, Principal investigator, UNC Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01017237
- Sponsor's protocol ID
- 08-2157
- Status last verified
- Apr 2012
- First submitted
- 14 Aug 2009
- Last updated
- 17 Jun 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effectiveness of Sedation With i.v. Dexmedetomidine in Combination With Midazolam Alone or Midazolam and Low Dose Ketamine for Extraction of Third Molars.
- ClinicalTrials.gov ID
- NCT01017237
- Acronym / sponsor ID
- 08-2157
- Conditions
- Anesthesia
- Keywords
- Dexmedetomidine sedation, Oral surgery sedation, Dexmedetomidine amnesia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Protocol proved to be ineffective for adequate sedation for third molar surgery.
- Enrolment
- 18 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Study start
- Jul 2009
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 20 Nov 2009 (estimated)
- Results
- Posted 17 Jun 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Intravenous sedation is used frequently for the relief of pain and anxiety associated with oral surgical procedures performed under local anesthesia. The purpose of this study is to learn about patient and surgeon satisfaction with sedation using Dexmedetomidine in combination with midazolam alone or with midazolam plus low dose ketamine while having wisdom teeth removed.
The sedation produced by dexmedetomidine is unique in that it mimics natural sleep, a unique quality not shared by other drugs. Dexmedetomidine is often used in anesthesia in hospital operating rooms and has been approved by the US Food and Drug Administration for the use planned in this study.
Detailed description
Subjects who have been screened medically and are scheduled for third molar surgery in the University of North Carolina (UNC)Oral and Maxillofacial Surgery (OMFS) clinic will be asked to volunteer for the study by the evaluating OMFS resident or attending physician. No additional x-rays will be taken other than those usually indicated for 3rd molar surgery. Informed consent will be obtained by study investigators.
Subjects will be instructed to fast for at least 8 hours prior to their appointment. Surgery will be performed in the Oral \& Maxillofacial Surgery operating/sedation clinic where all monitoring equipment as well as emergency equipment is readily available, including the ability to ventilate the patient with oxygen (bag-mask), the ability to intubate, resuscitation drugs and equipment including a defibrillator. Patients will be positioned in a semi-reclining position in the dental chair and all monitors applied. A 20 gauge i.v. catheter will be placed and normal saline infusion attached. Supplemental oxygen will be administered via nasal cannula at 3 liters per minute. A picture will then be shown for recall testing. Pulse rate, arterial oxygen saturation (SpO2), respiratory rate, blood pressure, end-tidal CO2 (ETCO2), Ramsey Sedation Score (RSS sedation score) and Bispectral Index Scale (BIS) value will be recorded as a baseline and at 5 minute intervals during the procedure. Any SpO2 values below 90% as well as any episodes of apnea greater than 20 seconds will be recorded. Monitoring and recording of all data will be done by one of the investigators. Data will be recorded on pre-printed data forms. The surgical procedure will be performed by an oral and maxillofacial surgery resident physician.
Following the administration of 0.12 mg/kg of dexamethasone , dexmedetomidine will be infused at a rate of 6 mcg/kg/hr for four minutes; resulting in a loading dose of 0.4 mcg/kg. All of the above parameters will again be obtained and recorded. Patients will be randomly assigned by block randomization to receive either midazolam 0.04 mg/kg i.v. (50 patients), or midazolam 0.04 mg/kg plus 0.25 mg/kg of ketamine (50 patients). The operating surgeon and the patient will be blinded as to which protocol is being used. A dexmedetomidine infusion of 0.5 mcg/kg/hr will be initiated and continued until the completion of surgery. At this point local anesthesia will be administered in all four quadrants. Pain reaction during injections will be recorded. When efficacy of local anesthesia has been confirmed, surgery will commence. The surgery will be interrupted at 15 and 30 minutes to show a picture for recall testing by an investigator. If at any point the patient is deemed to be uncomfortable or uncooperative due to inadequate sedation, the protocol will be broken and additional sedation administered as per usual standards. The rescue therapy may include additional midazolam, ketamine, narcotic or propofol at the discretion of the anesthetist/sedationist. At the conclusion of surgery the dexmedetomidine infusion will be discontinued and the patient will be attended by a recovery nurse for collection of postoperative data. During recovery the physiologic parameters will be recorded at 10 minute intervals. When the patient achieves a recovery Aldrete score of >9, they will be asked by an investigator to recall pictures for amnesia assessment, and asked to assess patient satisfaction before leaving with an escort. The patient will be contacted on the day following surgery by phone or e-mail by one of the investigators to test for recall of pictures shown (amnesia testing) and patient satisfaction
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dex plus midazolam | Active comparator | Drug: Dexmedetomidine, Drug: MidazolamDexmedetomidine loading dose of 0.4 mcg/kg followed by an infusion of 0.5 mcg/kg/hr plus midazolam 0.04 mg/kg i.v. |
| Dex plus midazolam and ketamine | Active comparator | Drug: Dexmedetomidine, Drug: Midazolam, Drug: KetamineDexmedetomidine loading dose of 0.4 mcg/kg followed by an infusion of 0.5 mcg/kg/hr plus midazolam 0.04 mg/kg and 0.25 mg/kg ketamine i.v. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- American Society of Anesthesiology (ASA) physical status I and II
- Four asymptomatic third molars indicated for removal
Key exclusion criteria (9 listed)
- Clinical history or ECG evidence of:
- chronic sedative or analgesic use
- allergies to any of the study drugs
- history of pericoronal infection with third molars
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 |
|---|---|---|
| DexmedetomidineAlso: PrecedexDexmedetomidine will be infused at a rate of 6 mcg/kg/hr for four minutes; resulting in a loading dose of 0.4 mcg/kg, Followed by an infusion of 0.5 mcg/kg/hr will be initiated and continued until the completion of surgery. | Drug | Dex plus midazolam, Dex plus midazolam and ketamine |
| MidazolamAlso: VersedMidazolam 0.04 mg/kg i.v. administered after dexmedetomidine loading dose. | Drug | Dex plus midazolam, Dex plus midazolam and ketamine |
| KetamineAlso: KetalarKetamine 0.25 mg/ml administered i.v. following the dexmedetomidine loading dose and the midazolam. | Drug | Dex plus midazolam and ketamine |
Primary outcome
Amnesia: Lack of Picture Recall Shown Prior to Sedation.
Time frame: Day of surgery prior to discharge
Subjects were shown pictures of familiar objects prior to sedation, after the bolus dose of dexmedetomidine was administered, at 15 minutes and 30 minutes into the surgery and at the end of surgery. Subjects were shown a page containing multiple pictures to evaluate whether they could remember any of them. No recall demonstrating the presence of amnesia during that portion of the procedure. This process was repeated the day following surgery
Amnesia: Lack of Recall One Day After Surgery of The Picture That Was Shown Prior to Sedation.
Time frame: One day after surgery
Lack of recall of picture shown indicates presence of amnesia the day following surgery.
Amnesia: Lack of Picture Recall Following Dexmedetomidine Infusion Plus Midazolam.
Time frame: Day of Surgery prior to discharge
Percentage of patients unable to recall picture
Amnesia: Lack of Recall One Day After Surgery of The Picture That Was Shown Following Dexmedetomidine Infusion Plus Midazolam.
Time frame: One day after surgery
Inability to recall picture shown at this time indicates presence of amnesia on the day following surgery.
Amnesia: Lack of Picture Recall Shown 15 Minutes Into Surgery
Time frame: Day of Surgery prior to discharge
Lack of recall of picture shown at this time indicates presence of amnesia
Amnesia: Lack of Recall One Day After Surgery of The Picture That Was Shown 15 Minutes Into Surgery.
Time frame: One day after surgery
Lack of recall of picture demonstrates presence of amnesia on day following surgery
Amnesia: Lack of Picture Recall Shown 30 Minutes Into Surgery
Time frame: Day of Surgery prior to discharge
Lack of recall of picture shown indicates presence of amnesia
Primary Title: Amnesia: Lack of Recall One Day After Surgery of The Picture That Was Shown 30 Minutes Into Surgery.
Time frame: One day after surgery
Lack of recall of picture shown indicates presence of amnesia on day following surgery.
Amnesia: Lack of Picture Recall at Surgery End Time.
Time frame: Day of surgery prior to discharge
Lack of recall of picture shown indicates presence of amnesia
Amnesia: Lack of Recall One Day After Surgery of The Picture That Was Shown at Surgery End Time.
Time frame: One day after surgery
Lack of recall of picture shown indicates presence of amnesia on day following surgery.
14 secondary outcomes
Respiratory Parameters: Respiratory Rate
Time frame: Immediately prior to sedation
Respiratory Parameters: Respiratory Rate
Time frame: During surgical procedure
Respiratory Parameters: Oxyhemoglobin Saturation
Time frame: Immediately prior to surgery
Respiratory Parameters: Oxyhemoglobin Saturation
Time frame: During surgical procedure
Respiratory Parameters: End-tidal Carbon Dioxide
Time frame: Immediately prior to sedation
Respiratory Parameters: End-tidal Carbon Dioxide
Time frame: Duration of surgery
Mean Arterial Blood Pressure
Time frame: Immediately prior to surgery
Mean Arterial Blood Pressure
Time frame: During duration of surgery
Heart Rate
Time frame: Prior to sedation
Heart Rate
Time frame: Duration of surgery
Surgeon Satisfaction With Sedation Technique
Time frame: After surgery completed: day of surgery, within 15 minutes
Patient Satisfaction With Sedation Technique
Time frame: after completion of surgery (within 15 minutes)
Ramsey Sedation Scale Score
Time frame: During surgical procedure
Bispectral Index Score (BIS)
Time frame: During surgery duration.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Jay A Anderson, DDS, MD principal investigator
UNC Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dexmedetomidine, Midazolam and Ketamine in people with Anesthesia, run by University of North Carolina, Chapel Hill at 1 site in United States.
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 2 inclusion and 9 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: stopped early, as of the sponsor's last update on 17 Jun 2013. 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 United States. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Jun 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Amnesia: Lack of Picture Recall Shown Prior to Sedation. (time frame: Day of surgery prior to discharge). The study lists 10 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 17 Jun 2013.