Deep SedationNCT05163704
Dexmedetomidine Sedation in Children Before MRI Examinations
A study testing Dexmedetomidine in people with Deep Sedation, run by Karolinska University Hospital at 1 site in Sweden.
Trial summary
Dexmedetomidine, has been used in the past 4-5 years as an alternative sedation method for children at the pediatric radiology department in order to reduce the waiting lists and the use of general anesthesia with its risks and side effects in magnetic resonance and computed tomography examinations. Read more about this study
- Who is it for?
- Ages 2 to 6 years
- Conditions the study is for
- Deep Sedation
- What is being tested?
- Dexmedetomidine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,091 participants
- Where
- 1 siteSweden
- Study dates
- 1 Nov 2017to 30 Jun 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 2 to 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Healthy children, according to the American Society of Anesthesiologists (ASA) risk classification. Children with ASA risk class 1 or 2 were selected by the anesthesiologist as suitable for radiographer handled sedation with Dexmedetomidine.
Who cannot join
- Children with significant comorbidity (ASA risk class 3 or 4) that were deemed to need presence of an anesthesia team (anesthesiologist plus certified anesthesia nurse) for safety reasons.
- Children that due to the specific nature of the MRI scan would need a general anesthetic to provide a secure airway (e.g., laryngeal mask airway or endotracheal intubation) during the scan (e.g., mild neck manipulation to assess cervical instability in Mb Down patients, multiple different MRI investigations requested or need for apnea).
- Children that present minimal cold symptoms the day of imaging.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Safe Sedation of Children During Radiological Examinations
Dexmedetomidine, has been used in the past 4-5 years as an alternative sedation method for children at the pediatric radiology department in order to reduce the waiting lists and the use of general anesthesia with its risks and side effects in magnetic resonance and computed tomography examinations.
Read the detailed description
Dexmedetomidine is a beneficial sedative for children. It provides a sedation equivalent to a natural deep sleep with negligible respiratory effects. The sedative can be administered intravenously, intranasally or buccally. Administration via the nose provides better absorption and faster impact effect. The drug does not taste and does not sting when administered. Dexmedetomidine is easy to administer and results in fewer anxious and upset patients. Monitoring the patient during the waiting period after application, during the examination itself and during the recovery period is a must. The study shows that a drug that can be administered intranasally, is practical and not invasive and means that the patient's anxiety is reduced, which can be considered an effective and safe method. Within the MRI unit at the pediatric radiology department, it has been necessary to design new routines for simple sedation, mainly due to the increased need for MRI examinations on children. Anesthesia and radiology staff have developed a new way of working where Dexmedetomidine is given nasally. These routines, including the referral flow, patient flow and staffing, have now been well established for about four years with very good results. The patient, who does not need to be fasting before the examination, receives a spray dose of the drug in the nose, falls into a deep sleep, is examined and then sleeps for about 30 minutes to an hour under supervision before returning home. It is the anesthetist who assesses which children are suitable for the type of sedation and radiology staff who are responsible for drug administration / monitoring of the patient. A preparation room is dedicated to these patients.
The patients were scheduled according to regular routine for dedicated Dexmedetomidine sedation sessions and only scans with an anticipated duration of maximum 1 hour were selected for the Dexmedetomidine protocol.
Following admission to the radiology out-patient clinic it was confirmed that the child's health condition had not changed since the last visit to the pediatrician, that there were no signs of an ongoing respiratory infection. No fasting requirements was used, and the child could eat and drink freely until arrival to the radiology clinic . Following admission and a brief period for the child to adapt to the new environment, heart rate (HR), pulse oximetry saturation and non-invasive blood pressure (NIBP) was recorded. The clinic was thereafter noticed from the MRI suite approximately 30 minutes prior to the scheduled time for the MRI examination. At this time the radiographer administered intra-nasal Dexmedetomidine. The child was then left with the accompanying caregiver/-s and the clinic nurses and checked after 15-20 min on how the sedation process evolved.
When called for, the patient was transported to the MRI suite together with the caregivers. If asleep or clearly sedated the child was placed in the MRI and prepared for the examination, which included ear plugs and noise protection earphones. A pulse oximeter probe was attached to monitor oxygenation and pulse rate. Noninvasive blood pressure or supplemental oxygen was not used during the scan since this may, according to previous clinical experience, awake the patients during the scanning procedure.
If the patient was deemed not sedated enough, an additional dose of intranasal Dexmedetomidine was administered and the child was left alone with the caregiver to allow it to settle following the administration. The child was thereafter continuously supervised by the radiographer. As the child developed a sufficient level of sedation the patient was then transferred to the scanner in the way described immediately above.
If two doses of intranasal Dexmedetomidine did not provide the desired result, the child was cancelled and rescheduled for a dedicated general anesthesia MRI session at a later occasion.
Following the scanning procedure, the ear plugs, and the noise protectors were removed, and the child was transferred from the gantry to the patient stretcher in the MRI suite area. Patients were allowed to wake up spontaneously during this process, no active efforts to wake them up were made. The pulse oximeter was left in place throughout transfer and until the child was deemed sufficiently alert in the clinic. When the child appeared reasonably awake and stable, a consensus decision made by the radiology personnel and the caregivers, the child and caregivers could return home. Before this, a new set of HR, NIBP and saturation was recorded.
- Conditions
- Deep Sedation
- Being tested
- Dexmedetomidine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
Also called Intranasal spray
Dexmedetomidine is a beneficial sedative for children. It provides a sedation equivalent to a natural deep sleep with negligible respiratory effects. Administration via the nose provides better absorption and faster impact effect. The drug does not taste and does not sting when administered.
| Study group | Role | What they receive |
|---|---|---|
| MRI Dexmedetomidine sedation | Other | Drug used: Dexmedetomidine. Given in increments of 0.2 ml at the time with atomizer (MAD Nasal™, Wayne Pennsylvania). Administered by radiology staff.
Dose 1 of nasal dexmedetomidine: 4 mcg/kg max 200 mcg Dose 2 of nasal dexmedetomidine: 2 mcg/kg max 100 mcg Receives: Drug: Dexmedetomidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in oxygen desaturation using Dexmedetomidine to replace general anesthesia prior to magnetic resonance imaging examination
During the scan the following important safety issue was followed: oxygen desaturation (SpO2 < 95 %) monitored by pulse oximetry. Low SpO2 was defined as a level below the mean value for age. If the SpO2 dropped below these levels, appropriate actions were taken (i.e., contact anesthesiologist).
Since no fasting restrictions is part of the Dexmedetomidine-MRI protocol, specific attention was paid to the potential occurrence of regurgitation of stomach contents and/or aspiration during the entire sedation period.
Pre- and post-sedation SpO2 (recorded in the radiology clinic pre- vs. post-scan) was compared to identify any negative effects on HR and NIBP during the early post-scan phase.
Measured: Pre-sedation, during examination and post-sedation up to 24 weeks
Changes in heart rate using Dexmedetomidine to replace general anesthesia prior to magnetic resonance imaging examination
During the scan the following important safety issue was followed: heart rate, monitored by pulse oximetry. Low heart rate was defined as a level below the mean value for age. If the heart rate dropped below these levels, appropriate actions were taken (i.e., contact anesthesiologist).
Pre- and post-sedation heart rate (recorded in the radiology clinic pre- vs. post-scan) were compared to identify any negative effects on SpO2 and NIBP during the early post-scan phase.
Measured: Pre-sedation, during examination and post-sedation up to 24 weeks
Changes in non-invasive blood preassure using Dexmedetomidine to replace general Changes in NIBP using Dexmedetomidine to replace anesthesia prior to magnetic resonance imaging examination
During the scan the following important safety issue was followed: NIBP monitored. Low or high systolic and/or dyastolic blood preassure was defined according the mean value for age. If any of parameters changed below/above the normal levels for age, appropriate actions were taken (i.e., contact anesthesiologist).
Pre- and post-sedation NIBP (recorded in the radiology clinic pre- vs. post-scan) were compared to identify any negative effects on HR and SpO2 during the early post-scan phase.
Measured: Pre-sedation, during examination and post-sedation up to 24 weeks
Secondary outcomes (1)
Assessment of image quality using Dexmedetomidine as a sedative for children undergoing MRI examination
All scans were reviewed by a certified pediatric MRI radiologist. Scan quality was classified as optimal, slight sub-optimal but of acceptable quality to answer the diagnostic question or inadequate to allow any acceptable radiologic interpretation.
Measured: After sedation through study completion, an average of 1.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2021
- Study start1 Nov 2017
- Primary completion30 Jun 2021
- Study completion30 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Deep SedationStudies of the same condition, open and under way.
- More trials run by Karolinska University HospitalThe sponsor's other registered studies.
- 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,091 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sandra Diaz Ruiz, Karolinska University Hospital
- Investigators
- Joakim Dillner, MD PhD, Study chair, Karolinska University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05163704
- Sponsor's protocol ID
- MR-Dexdor
- Status last verified
- Dec 2021
- First submitted
- 17 Nov 2021
- Last updated
- 20 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We keep working to find the lowest dose of Dexmedetomidine as possible to reach a satisfactory sedation dose. We can share our preliminary results with the actual doses but we think that lower doses can be used to obtain the same good results.
Publications
Pansini V, Curatola A, Gatto A, Lazzareschi I, Ruggiero A, Chiaretti A. Intranasal drugs for analgesia and sedation in children admitted to pediatric emergency department: a narrative review. Ann Transl Med. 2021 Jan;9(2):189. doi: 10.21037/atm-20-5177.
PubMed 33569491Zhang Y, Zhang R, Meng HY, Wang MX, Du SZ. [Efficacy and safety of intranasal dexmedetomidine premedication for children undergoing CT or magnetic resonance imaging: a systematic review and meta-analysis]. Zhonghua Er Ke Za Zhi. 2020 Apr 2;58(4):314-318. doi: 10.3760/cma.j.cn112140-20191224-00830. Chinese.
PubMed 32234139Li L, Zhou J, Yu D, Hao X, Xie Y, Zhu T. Intranasal dexmedetomidine versus oral chloral hydrate for diagnostic procedures sedation in infants and toddlers: A systematic review and meta-analysis. Medicine (Baltimore). 2020 Feb;99(9):e19001. doi: 10.1097/MD.0000000000019001.
PubMed 32118711Mondardini MC, Amigoni A, Cortellazzi P, Di Palma A, Navarra C, Picardo SG, Puzzutiello R, Rinaldi L, Vitale F, Zito Marinosci G, Conti G. Intranasal dexmedetomidine in pediatrics: update of current knowledge. Minerva Anestesiol. 2019 Dec;85(12):1334-1345. doi: 10.23736/S0375-9393.19.13820-5. Epub 2019 Oct 14.
PubMed 31630510Uusalo P, Guillaume S, Siren S, Manner T, Vilo S, Scheinin M, Saari TI. Pharmacokinetics and Sedative Effects of Intranasal Dexmedetomidine in Ambulatory Pediatric Patients. Anesth Analg. 2020 Apr;130(4):949-957. doi: 10.1213/ANE.0000000000004264.
PubMed 31206433Karlsson J, Lewis G, Larsson P, Lonnqvist PA, Diaz S. Intranasal dexmedetomidine sedation for paediatric MRI by radiology personnel: A retrospective observational study. Eur J Anaesthesiol. 2023 Mar 1;40(3):208-215. doi: 10.1097/EJA.0000000000001786. Epub 2022 Dec 22.
PubMed 36546479
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safe Sedation of Children During Radiological Examinations
- ClinicalTrials.gov ID
- NCT05163704
- Acronym / sponsor ID
- MR-Dexdor
- Conditions
- Deep Sedation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,091 participants (actual)
- Lead sponsor
- Karolinska University HospitalUniversity, hospital or other
- Study start
- 1 Nov 2017 (actual)
- Primary completion
- 30 Jun 2021 (actual)
- Study completion
- 30 Jun 2021 (actual)
- First posted
- 20 Dec 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.
Dexmedetomidine, has been used in the past 4-5 years as an alternative sedation method for children at the pediatric radiology department in order to reduce the waiting lists and the use of general anesthesia with its risks and side effects in magnetic resonance and computed tomography examinations.
Detailed description
Dexmedetomidine is a beneficial sedative for children. It provides a sedation equivalent to a natural deep sleep with negligible respiratory effects. The sedative can be administered intravenously, intranasally or buccally. Administration via the nose provides better absorption and faster impact effect. The drug does not taste and does not sting when administered. Dexmedetomidine is easy to administer and results in fewer anxious and upset patients. Monitoring the patient during the waiting period after application, during the examination itself and during the recovery period is a must. The study shows that a drug that can be administered intranasally, is practical and not invasive and means that the patient's anxiety is reduced, which can be considered an effective and safe method. Within the MRI unit at the pediatric radiology department, it has been necessary to design new routines for simple sedation, mainly due to the increased need for MRI examinations on children. Anesthesia and radiology staff have developed a new way of working where Dexmedetomidine is given nasally. These routines, including the referral flow, patient flow and staffing, have now been well established for about four years with very good results. The patient, who does not need to be fasting before the examination, receives a spray dose of the drug in the nose, falls into a deep sleep, is examined and then sleeps for about 30 minutes to an hour under supervision before returning home. It is the anesthetist who assesses which children are suitable for the type of sedation and radiology staff who are responsible for drug administration / monitoring of the patient. A preparation room is dedicated to these patients.
The patients were scheduled according to regular routine for dedicated Dexmedetomidine sedation sessions and only scans with an anticipated duration of maximum 1 hour were selected for the Dexmedetomidine protocol.
Following admission to the radiology out-patient clinic it was confirmed that the child's health condition had not changed since the last visit to the pediatrician, that there were no signs of an ongoing respiratory infection. No fasting requirements was used, and the child could eat and drink freely until arrival to the radiology clinic . Following admission and a brief period for the child to adapt to the new environment, heart rate (HR), pulse oximetry saturation and non-invasive blood pressure (NIBP) was recorded. The clinic was thereafter noticed from the MRI suite approximately 30 minutes prior to the scheduled time for the MRI examination. At this time the radiographer administered intra-nasal Dexmedetomidine. The child was then left with the accompanying caregiver/-s and the clinic nurses and checked after 15-20 min on how the sedation process evolved.
When called for, the patient was transported to the MRI suite together with the caregivers. If asleep or clearly sedated the child was placed in the MRI and prepared for the examination, which included ear plugs and noise protection earphones. A pulse oximeter probe was attached to monitor oxygenation and pulse rate. Noninvasive blood pressure or supplemental oxygen was not used during the scan since this may, according to previous clinical experience, awake the patients during the scanning procedure.
If the patient was deemed not sedated enough, an additional dose of intranasal Dexmedetomidine was administered and the child was left alone with the caregiver to allow it to settle following the administration. The child was thereafter continuously supervised by the radiographer. As the child developed a sufficient level of sedation the patient was then transferred to the scanner in the way described immediately above.
If two doses of intranasal Dexmedetomidine did not provide the desired result, the child was cancelled and rescheduled for a dedicated general anesthesia MRI session at a later occasion.
Following the scanning procedure, the ear plugs, and the noise protectors were removed, and the child was transferred from the gantry to the patient stretcher in the MRI suite area. Patients were allowed to wake up spontaneously during this process, no active efforts to wake them up were made. The pulse oximeter was left in place throughout transfer and until the child was deemed sufficiently alert in the clinic. When the child appeared reasonably awake and stable, a consensus decision made by the radiology personnel and the caregivers, the child and caregivers could return home. Before this, a new set of HR, NIBP and saturation was recorded.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MRI Dexmedetomidine sedation | Other | Drug: DexmedetomidineDrug used: Dexmedetomidine. Given in increments of 0.2 ml at the time with atomizer (MAD Nasal™, Wayne Pennsylvania). Administered by radiology staff. Dose 1 of nasal dexmedetomidine: 4 mcg/kg max 200 mcg Dose 2 of nasal dexmedetomidine: 2 mcg/kg max 100 mcg |
Who may qualify
- Ages
- 2 to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Healthy children, according to the American Society of Anesthesiologists (ASA) risk classification. Children with ASA risk class 1 or 2 were selected by the anesthesiologist as suitable for radiographer handled sedation with Dexmedetomidine.
Key exclusion criteria (3 listed)
- Children with significant comorbidity (ASA risk class 3 or 4) that were deemed to need presence of an anesthesia team (anesthesiologist plus certified anesthesia nurse) for safety reasons.
- Children that due to the specific nature of the MRI scan would need a general anesthetic to provide a secure airway (e.g., laryngeal mask airway or endotracheal intubation) during the scan (e.g., mild neck manipulation to assess cervical instability in Mb Down patients, multiple different MRI investigations requested or need for apnea).
- Children that present minimal cold symptoms the day of imaging.
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: Intranasal sprayDexmedetomidine is a beneficial sedative for children. It provides a sedation equivalent to a natural deep sleep with negligible respiratory effects. Administration via the nose provides better absorption and faster impact effect. The drug does not taste and does not sting when administered. | Drug | MRI Dexmedetomidine sedation |
Primary outcome
Changes in oxygen desaturation using Dexmedetomidine to replace general anesthesia prior to magnetic resonance imaging examination
Time frame: Pre-sedation, during examination and post-sedation up to 24 weeks
During the scan the following important safety issue was followed: oxygen desaturation (SpO2 < 95 %) monitored by pulse oximetry. Low SpO2 was defined as a level below the mean value for age. If the SpO2 dropped below these levels, appropriate actions were taken (i.e., contact anesthesiologist). Since no fasting restrictions is part of the Dexmedetomidine-MRI protocol, specific attention was paid to the potential occurrence of regurgitation of stomach contents and/or aspiration during the entire sedation period. Pre- and post-sedation SpO2 (recorded in the radiology clinic pre- vs. post-scan) was compared to identify any negative effects on HR and NIBP during the early post-scan phase.
Changes in heart rate using Dexmedetomidine to replace general anesthesia prior to magnetic resonance imaging examination
Time frame: Pre-sedation, during examination and post-sedation up to 24 weeks
During the scan the following important safety issue was followed: heart rate, monitored by pulse oximetry. Low heart rate was defined as a level below the mean value for age. If the heart rate dropped below these levels, appropriate actions were taken (i.e., contact anesthesiologist). Pre- and post-sedation heart rate (recorded in the radiology clinic pre- vs. post-scan) were compared to identify any negative effects on SpO2 and NIBP during the early post-scan phase.
Changes in non-invasive blood preassure using Dexmedetomidine to replace general Changes in NIBP using Dexmedetomidine to replace anesthesia prior to magnetic resonance imaging examination
Time frame: Pre-sedation, during examination and post-sedation up to 24 weeks
During the scan the following important safety issue was followed: NIBP monitored. Low or high systolic and/or dyastolic blood preassure was defined according the mean value for age. If any of parameters changed below/above the normal levels for age, appropriate actions were taken (i.e., contact anesthesiologist). Pre- and post-sedation NIBP (recorded in the radiology clinic pre- vs. post-scan) were compared to identify any negative effects on HR and SpO2 during the early post-scan phase.
1 secondary outcome
Assessment of image quality using Dexmedetomidine as a sedative for children undergoing MRI examination
Time frame: After sedation through study completion, an average of 1.5 years
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 20 Dec 2021.
- Results publication: PubMed 33569491Pansini V, Curatola A, Gatto A, Lazzareschi I, Ruggiero A, Chiaretti A. Intranasal drugs for analgesia and sedation in children admitted to pediatric emergency department: a narrative review. Ann Transl Med. 2021 Jan;9(2):189. doi: 10.21037/atm-20-5177.
- Results publication: PubMed 32234139Zhang Y, Zhang R, Meng HY, Wang MX, Du SZ. [Efficacy and safety of intranasal dexmedetomidine premedication for children undergoing CT or magnetic resonance imaging: a systematic review and meta-analysis]. Zhonghua Er Ke Za Zhi. 2020 Apr 2;58(4):314-318. doi: 10.3760/cma.j.cn112140-20191224-00830. Chinese.
- Results publication: PubMed 32118711Li L, Zhou J, Yu D, Hao X, Xie Y, Zhu T. Intranasal dexmedetomidine versus oral chloral hydrate for diagnostic procedures sedation in infants and toddlers: A systematic review and meta-analysis. Medicine (Baltimore). 2020 Feb;99(9):e19001. doi: 10.1097/MD.0000000000019001.
- Results publication: PubMed 31630510Mondardini MC, Amigoni A, Cortellazzi P, Di Palma A, Navarra C, Picardo SG, Puzzutiello R, Rinaldi L, Vitale F, Zito Marinosci G, Conti G. Intranasal dexmedetomidine in pediatrics: update of current knowledge. Minerva Anestesiol. 2019 Dec;85(12):1334-1345. doi: 10.23736/S0375-9393.19.13820-5. Epub 2019 Oct 14.
- Results publication: PubMed 31206433Uusalo P, Guillaume S, Siren S, Manner T, Vilo S, Scheinin M, Saari TI. Pharmacokinetics and Sedative Effects of Intranasal Dexmedetomidine in Ambulatory Pediatric Patients. Anesth Analg. 2020 Apr;130(4):949-957. doi: 10.1213/ANE.0000000000004264.
- Derived from this study: PubMed 36546479Karlsson J, Lewis G, Larsson P, Lonnqvist PA, Diaz S. Intranasal dexmedetomidine sedation for paediatric MRI by radiology personnel: A retrospective observational study. Eur J Anaesthesiol. 2023 Mar 1;40(3):208-215. doi: 10.1097/EJA.0000000000001786. Epub 2022 Dec 22.
- Individual participant dataSharing planned: Yes. We keep working to find the lowest dose of Dexmedetomidine as possible to reach a satisfactory sedation dose. We can share our preliminary results with the actual doses but we think that lower doses can be used to obtain the same good results.
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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.
Joakim Dillner, MD PhD study chair
Karolinska University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dexmedetomidine in people with Deep Sedation, run by Karolinska University Hospital at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 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 20 Dec 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 Sweden. 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?
Changes in oxygen desaturation using Dexmedetomidine to replace general anesthesia prior to magnetic resonance imaging examination (time frame: Pre-sedation, during examination and post-sedation up to 24 weeks). The study lists 3 primary outcomes in all. 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 NCT05163704, which also lists 6 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 20 Dec 2021.