AnesthesiaPhase 4NCT04798482
Effect of Dexmedetomidine of Gastrointestinal Motility
A Phase 4 study testing Dexmedetomidine in people with Anesthesia, run by Boston Children's Hospital at 1 site in United States.
Trial summary
Anorectal manometry requires that the patient be able to respond to command and not receive any medications which could alter muscle tone or motility. In the pediatric population, anorectal manometry can be psychologically challenging to parents and their child, as it is traditionally performed without adjuvant… Read more about this study
- Who is it for?
- Ages 3 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Anesthesia
- What is being tested?
- Dexmedetomidine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Sep 2021to 15 Nov 2022
- 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 3 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Ages 3-18 years who are scheduled to have an anorectal manometry followed by an upper or lower endoscopic procedures at Boston Children's Hospital
- Patients are cooperative to do the anorectal manometry without sedation (besides pre-med midazolam)
- Anticipates to receive standard sedation with dexmedetomidine and propofol for a gastrointestinal procedure in the Gastroenterology Procedure Unit (GPU)
- Provides written consent to participate in the research study
- In females of reproductive age, pregnancy testing
Who cannot join
- Do not meet established sedation criteria
- Patients who require sedation prior to their anal manometry testing
- History of allergy, intolerance, or reaction to dexmedetomidine
- Current, repaired or risk of Moya-Moya disease
- Recent stroke (cerebrovascular accident) within past 6 months
- Uncontrolled hypertension
Show all 16Show fewer
- Concomitant use of opioids, beta antagonist, alpha 2 agonist or calcium channel blocker
- BMI greater than 30 or weight above 110th percentile
- Refuses insertion of intravenous catheter while awake
- Currently receiving pharmacologic agents for hypertension or cardiac disease
- Currently receiving or has received digoxin within the past 3 months
- Active, uncontrolled gastroesophageal reflux (an aspiration risk), requiring endotracheal intubation.
- Current (or within past 3 months) history of apnea requiring an apnea monitor
- Unstable cardiac status (life threatening arrhythmias, abnormal cardiac anatomy, significant cardiac dysfunction)
- Craniofacial anomaly, which could make it difficult to effectively establish a mask airway for positive pressure ventilation if needed
- Active, current respiratory issues that are different from the baseline status (pneumonia, exacerbation of asthma, bronchiolitis, respiratory syncytial virus).
Trial locations and contacts
1 site in 1 country.
United States1 site
Boston Children's Hospital
Boston, Massachusetts, 02115
About this study
Anorectal manometry requires that the patient be able to respond to command and not receive any medications which could alter muscle tone or motility. In the pediatric population, anorectal manometry can be psychologically challenging to parents and their child, as it is traditionally performed without adjuvant sedation or anesthesia. Sedatives and anesthesia can alter motility and smooth muscle activity, as well as render it difficult or impossible for the child to follow commands required of the study. Patient or parent non-compliance, inability to follow commands or to tolerate the procedure often renders the study invalid or impossible to complete. Dexmedetomidine is a sedative who's effect on anorectal musculature has not been studied nor determined. It would be important to determine whether it spares smooth muscle function, as it would provide a viable option to provide sedation to children while still preserving their ability to respond to command. The primary objective of this study is to examine the effects of dexmedetomidine on gastrointestinal smooth muscle by observing changes in anorectal manometry before and after dexmedetomdine administration.
Read the detailed description
Primary objective:
To examine the effects of dexmedetomidine on intra-anal pressure and the dose response curve to balloon distention by comparing the baseline measurements with those after dexmedetomidine administration.
Dexmedetomidine is an alpha-2 agonist that is considered to be a smooth muscle relaxant. It's a potential use as a sedative for endoscopies has been considered. It is important to know whether or not it has effect on smooth muscle tone and would affect manometry studies in those patients who could receive it. The investigator hypothesizes that dexmedetomidine will have minimal effects in the dosing that is being administered.
Background:
Anorectal manometry requires that the patient be able to respond to command and not receive any medications which could alter muscle tone or motility. These patients typically have the manometry performed without any adjuvant sedatives, anesthetics or medications. In the pediatric population, anorectal manometry can be psychologically challenging to parents and their child, particularly without adjuvant sedation or anesthesia. There are some exceptional circumstances which require sedation/anesthesia administration for these procedures, either because the children are young (< 5 years), they have behavioral issues (like autism) or because they have severe anxiety. In those patients with severe issues even general anesthesia may be needed. The risk of administering any medication to these patients is that they can alter motility and smooth muscle activity, consequently artificially altering the results of the anal manometry. It is important to know which medications can be administered without affecting anal muscle tone. Dexmedetomidine is a newer sedative and anxiolytic. It could be valuable for anxiolysis for anal manometry. It's effect on anal smooth muscle, however, has never been studied. It would be important to determine whether it spares smooth muscle function, as it would provide a viable option to provide sedation to children while still preserving their ability to respond to command.
Dexmedetomidine is one of the standard drugs administered for sedation in children who require sedation for diagnostic (gastroendoscopic upper and lower procedures) and radiologic diagnostic imaging studies (MRI, CT and Nuclear Medicine). Over 17,000 infants, children and developmentally compromised young adults have been sedated with dexmedetomidine at Boston Children's Hospital without a cardiac or respiratory arrest, or a need to provide positive pressure assisted ventilation.
Methods:
Patients will undergo the usual anal manometry study, with no adjuvant medications, per routine practice currently in the gastrointestinal unit. Following completion of manometry, 0.5 mcg/kg DEX will be administered over 1 minute followed by an infusion of 0.15 mcg/kg/hr. Manometry measurements will be followed for 15 minutes in response to DEX.
Definition of Primary Endpoint:
Primary outcome: To examine the effects of dexmedetomidine on intra-anal pressure and the dose response curve to balloon distention by comparing the baseline measurements with those after dexmedetomidine administration. The pressure measurements will be recorded by the research team member who will be present, every 30 seconds starting from 5 minutes prior to DEX to 15 minutes following DEX administration.
Data Analysis Plan:
Data will be analyzed after the completion of the study. The manometry measurements will be done blindly by one of the investigators.
The following endpoints will be analyzed at the completion of the study: time to meet modified Aldrete discharge criteria, adverse events, need for unplanned airway interventions, intravenous anesthetic duration of sedation, presence of agitation/delirium (PAED score), and time of BIS score to return to baseline (pre-sedation level).
Statistical Power and Sample Considerations:
The study was powered and sample size calculated assuming a mean intra-anal pressure of 90 mmHg, with a mean reduction to 65 mmHg, and a standard deviation of 32. With a significance level of 0.05, it would require approximately 15 subjects to achieve power of 80.3%.
- Conditions
- Anesthesia
- Being tested
- Dexmedetomidine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
Patients will undergo the usual anal manometry study, with no adjuvant medications, per routine practice currently in the gastrointestinal unit. Following completion of manometry, 0.5 mcg/kg DEX will be administered over 1 minute followed by an infusion of 0.15 mcg/kg/hr. Manometry measurements will be followed for 15 minutes in response to DEX.
| Study group | Role | What they receive |
|---|---|---|
| Dexmedetomidine | Experimental | This is a single arm, open label, interventional study examining the effects of dexmedetomidine on anal manometry. All subjects will be administered dexmedetomidine following their baseline manometry measurements. Following dexmedetomidine administration, anal manometry measurements will be observed for 15 minutes. Receives: Drug: Dexmedetomidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intra-anal Sphincter Pressure (IASP) 1 Minute After Dexmedetomidine Administration
Measured: 1 minute
Intra-anal Sphincter Pressure (IASP) 5 Minutes After Dexmedetomidine Administration
Measured: 5 minutes
Intra-anal Sphincter Pressure (IASP) Baseline Measurement
IASP recorded prior to administration of dexmedetomidine
Measured: 30 seconds
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2021
- Study start14 Sep 2021
- Primary completion15 Nov 2022
- Study completion15 Nov 2022
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.
- Publications (22)Papers the sponsor has linked to this study.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- More trials run by Boston Children's 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 4
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Keira Mason, Boston Children's Hospital
- Investigators
- Keira Mason, MD, Principal investigator, Boston Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04798482
- Sponsor's protocol ID
- IRB-P00035865
- Status last verified
- Apr 2024
- First submitted
- 18 Feb 2021
- Last updated
- 26 Apr 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Aantaa R, Kanto J, Scheinin M, Kallio A, Scheinin H. Dexmedetomidine, an alpha 2-adrenoceptor agonist, reduces anesthetic requirements for patients undergoing minor gynecologic surgery. Anesthesiology. 1990 Aug;73(2):230-5. doi: 10.1097/00000542-199008000-00007.
PubMed 1974394Ambartsumyan L, Rodriguez L, Morera C, Nurko S. Longitudinal and radial characteristics of intra-anal pressures in children using 3D high-definition anorectal manometry: new observations. Am J Gastroenterol. 2013 Dec;108(12):1918-28. doi: 10.1038/ajg.2013.361. Epub 2013 Oct 29.
PubMed 24169274Ozkose Z, Demir FS, Pampal K, Yardim S. Hemodynamic and anesthetic advantages of dexmedetomidine, an alpha 2-agonist, for surgery in prone position. Tohoku J Exp Med. 2006 Oct;210(2):153-60. doi: 10.1620/tjem.210.153.
PubMed 17023769Gurbet A, Basagan-Mogol E, Turker G, Ugun F, Kaya FN, Ozcan B. Intraoperative infusion of dexmedetomidine reduces perioperative analgesic requirements. Can J Anaesth. 2006 Jul;53(7):646-52. doi: 10.1007/BF03021622.
PubMed 16803911Pestieau SR, Quezado ZM, Johnson YJ, Anderson JL, Cheng YI, McCarter RJ, Choi S, Finkel JC. High-dose dexmedetomidine increases the opioid-free interval and decreases opioid requirement after tonsillectomy in children. Can J Anaesth. 2011 Jun;58(6):540-50. doi: 10.1007/s12630-011-9493-7. Epub 2011 Apr 2.
PubMed 21461792Le Guen M, Liu N, Tounou F, Auge M, Tuil O, Chazot T, Dardelle D, Laloe PA, Bonnet F, Sessler DI, Fischler M. Dexmedetomidine reduces propofol and remifentanil requirements during bispectral index-guided closed-loop anesthesia: a double-blind, placebo-controlled trial. Anesth Analg. 2014 May;118(5):946-55. doi: 10.1213/ANE.0000000000000185.
PubMed 24722260Morera C, Nurko S. Rectal manometry in patients with isolated sacral agenesis. J Pediatr Gastroenterol Nutr. 2003 Jul;37(1):47-52. doi: 10.1097/00005176-200307000-00008.
PubMed 12827005Sen S, Chakraborty J, Santra S, Mukherjee P, Das B. The effect of dexmedetomidine infusion on propofol requirement for maintenance of optimum depth of anaesthesia during elective spine surgery. Indian J Anaesth. 2013 Jul;57(4):358-63. doi: 10.4103/0019-5049.118558.
PubMed 24163449Al-Zaben KR, Qudaisat IY, Al-Ghanem SM, Massad IM, Al-Mustafa MM, Al-Oweidi AS, Abu-Halaweh SA, Abu-Ali HM, Saleem MM. Intraoperative administration of dexmedetomidine reduces the analgesic requirements for children undergoing hypospadius surgery. Eur J Anaesthesiol. 2010 Mar;27(3):247-52. doi: 10.1097/EJA.0b013e32833522bf.
PubMed 19952754Mason KP, Zurakowski D, Zgleszewski SE, Robson CD, Carrier M, Hickey PR, Dinardo JA. High dose dexmedetomidine as the sole sedative for pediatric MRI. Paediatr Anaesth. 2008 May;18(5):403-11. doi: 10.1111/j.1460-9592.2008.02468.x. Epub 2008 Mar 18.
PubMed 18363626Mason KP, Zgleszewski SE, Dearden JL, Dumont RS, Pirich MA, Stark CD, D'Angelo P, Macpherson S, Fontaine PJ, Connor L, Zurakowski D. Dexmedetomidine for pediatric sedation for computed tomography imaging studies. Anesth Analg. 2006 Jul;103(1):57-62, table of contents. doi: 10.1213/01.ane.0000216293.16613.15.
PubMed 16790626Heard C, Burrows F, Johnson K, Joshi P, Houck J, Lerman J. A comparison of dexmedetomidine-midazolam with propofol for maintenance of anesthesia in children undergoing magnetic resonance imaging. Anesth Analg. 2008 Dec;107(6):1832-9. doi: 10.1213/ane.0b013e31818874ee.
PubMed 19020127Kol IO, Egilmez H, Kaygusuz K, Gursoy S, Mimaroglu C. Open-label, prospective, randomized comparison of propofol and sevoflurane for laryngeal mask anesthesia for magnetic resonance imaging in pediatric patients. Clin Ther. 2008 Jan;30(1):175-81. doi: 10.1016/j.clinthera.2008.01.008.
PubMed 18343254Koroglu A, Teksan H, Sagir O, Yucel A, Toprak HI, Ersoy OM. A comparison of the sedative, hemodynamic, and respiratory effects of dexmedetomidine and propofol in children undergoing magnetic resonance imaging. Anesth Analg. 2006 Jul;103(1):63-7, table of contents. doi: 10.1213/01.ANE.0000219592.82598.AA.
PubMed 16790627Cravero JP, Beach ML, Blike GT, Gallagher SM, Hertzog JH; Pediatric Sedation Research Consortium. The incidence and nature of adverse events during pediatric sedation/anesthesia with propofol for procedures outside the operating room: a report from the Pediatric Sedation Research Consortium. Anesth Analg. 2009 Mar;108(3):795-804. doi: 10.1213/ane.0b013e31818fc334.
PubMed 19224786
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Dexmedetomidine of Gastrointestinal Motility
- ClinicalTrials.gov ID
- NCT04798482
- Acronym / sponsor ID
- IRB-P00035865
- Conditions
- Anesthesia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Boston Children's HospitalUniversity, hospital or other
- Study start
- 14 Sep 2021 (actual)
- Primary completion
- 15 Nov 2022 (actual)
- Study completion
- 15 Nov 2022 (actual)
- First posted
- 15 Mar 2021 (actual)
- Results
- Posted 26 Apr 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Anorectal manometry requires that the patient be able to respond to command and not receive any medications which could alter muscle tone or motility. In the pediatric population, anorectal manometry can be psychologically challenging to parents and their child, as it is traditionally performed without adjuvant sedation or anesthesia. Sedatives and anesthesia can alter motility and smooth muscle activity, as well as render it difficult or impossible for the child to follow commands required of the study. Patient or parent non-compliance, inability to follow commands or to tolerate the procedure often renders the study invalid or impossible to complete. Dexmedetomidine is a sedative who's effect on anorectal musculature has not been studied nor determined. It would be important to determine whether it spares smooth muscle function, as it would provide a viable option to provide sedation to children while still preserving their ability to respond to command. The primary objective of this study is to examine the effects of dexmedetomidine on gastrointestinal smooth muscle by observing changes in anorectal manometry before and after dexmedetomdine administration.
Detailed description
Primary objective:
To examine the effects of dexmedetomidine on intra-anal pressure and the dose response curve to balloon distention by comparing the baseline measurements with those after dexmedetomidine administration.
Dexmedetomidine is an alpha-2 agonist that is considered to be a smooth muscle relaxant. It's a potential use as a sedative for endoscopies has been considered. It is important to know whether or not it has effect on smooth muscle tone and would affect manometry studies in those patients who could receive it. The investigator hypothesizes that dexmedetomidine will have minimal effects in the dosing that is being administered.
Background:
Anorectal manometry requires that the patient be able to respond to command and not receive any medications which could alter muscle tone or motility. These patients typically have the manometry performed without any adjuvant sedatives, anesthetics or medications. In the pediatric population, anorectal manometry can be psychologically challenging to parents and their child, particularly without adjuvant sedation or anesthesia. There are some exceptional circumstances which require sedation/anesthesia administration for these procedures, either because the children are young (< 5 years), they have behavioral issues (like autism) or because they have severe anxiety. In those patients with severe issues even general anesthesia may be needed. The risk of administering any medication to these patients is that they can alter motility and smooth muscle activity, consequently artificially altering the results of the anal manometry. It is important to know which medications can be administered without affecting anal muscle tone. Dexmedetomidine is a newer sedative and anxiolytic. It could be valuable for anxiolysis for anal manometry. It's effect on anal smooth muscle, however, has never been studied. It would be important to determine whether it spares smooth muscle function, as it would provide a viable option to provide sedation to children while still preserving their ability to respond to command.
Dexmedetomidine is one of the standard drugs administered for sedation in children who require sedation for diagnostic (gastroendoscopic upper and lower procedures) and radiologic diagnostic imaging studies (MRI, CT and Nuclear Medicine). Over 17,000 infants, children and developmentally compromised young adults have been sedated with dexmedetomidine at Boston Children's Hospital without a cardiac or respiratory arrest, or a need to provide positive pressure assisted ventilation.
Methods:
Patients will undergo the usual anal manometry study, with no adjuvant medications, per routine practice currently in the gastrointestinal unit. Following completion of manometry, 0.5 mcg/kg DEX will be administered over 1 minute followed by an infusion of 0.15 mcg/kg/hr. Manometry measurements will be followed for 15 minutes in response to DEX.
Definition of Primary Endpoint:
Primary outcome: To examine the effects of dexmedetomidine on intra-anal pressure and the dose response curve to balloon distention by comparing the baseline measurements with those after dexmedetomidine administration. The pressure measurements will be recorded by the research team member who will be present, every 30 seconds starting from 5 minutes prior to DEX to 15 minutes following DEX administration.
Data Analysis Plan:
Data will be analyzed after the completion of the study. The manometry measurements will be done blindly by one of the investigators.
The following endpoints will be analyzed at the completion of the study: time to meet modified Aldrete discharge criteria, adverse events, need for unplanned airway interventions, intravenous anesthetic duration of sedation, presence of agitation/delirium (PAED score), and time of BIS score to return to baseline (pre-sedation level).
Statistical Power and Sample Considerations:
The study was powered and sample size calculated assuming a mean intra-anal pressure of 90 mmHg, with a mean reduction to 65 mmHg, and a standard deviation of 32. With a significance level of 0.05, it would require approximately 15 subjects to achieve power of 80.3%.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dexmedetomidine | Experimental | Drug: DexmedetomidineThis is a single arm, open label, interventional study examining the effects of dexmedetomidine on anal manometry. All subjects will be administered dexmedetomidine following their baseline manometry measurements. Following dexmedetomidine administration, anal manometry measurements will be observed for 15 minutes. |
Who may qualify
- Ages
- 3 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Ages 3-18 years who are scheduled to have an anorectal manometry followed by an upper or lower endoscopic procedures at Boston Children's Hospital
- Patients are cooperative to do the anorectal manometry without sedation (besides pre-med midazolam)
- Anticipates to receive standard sedation with dexmedetomidine and propofol for a gastrointestinal procedure in the Gastroenterology Procedure Unit (GPU)
- Provides written consent to participate in the research study
- In females of reproductive age, pregnancy testing
Key exclusion criteria (16 listed)
- Do not meet established sedation criteria
- Patients who require sedation prior to their anal manometry testing
- History of allergy, intolerance, or reaction to dexmedetomidine
- Current, repaired or risk of Moya-Moya disease
- Recent stroke (cerebrovascular accident) within past 6 months
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 |
|---|---|---|
| DexmedetomidinePatients will undergo the usual anal manometry study, with no adjuvant medications, per routine practice currently in the gastrointestinal unit. Following completion of manometry, 0.5 mcg/kg DEX will be administered over 1 minute followed by an infusion of 0.15 mcg/kg/hr. Manometry measurements will be followed for 15 minutes in response to DEX. | Drug | Dexmedetomidine |
Primary outcome
Intra-anal Sphincter Pressure (IASP) 1 Minute After Dexmedetomidine Administration
Time frame: 1 minute
Intra-anal Sphincter Pressure (IASP) 5 Minutes After Dexmedetomidine Administration
Time frame: 5 minutes
Intra-anal Sphincter Pressure (IASP) Baseline Measurement
Time frame: 30 seconds
IASP recorded prior to administration of dexmedetomidine
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 1974394Aantaa R, Kanto J, Scheinin M, Kallio A, Scheinin H. Dexmedetomidine, an alpha 2-adrenoceptor agonist, reduces anesthetic requirements for patients undergoing minor gynecologic surgery. Anesthesiology. 1990 Aug;73(2):230-5. doi: 10.1097/00000542-199008000-00007.
- Background: PubMed 24169274Ambartsumyan L, Rodriguez L, Morera C, Nurko S. Longitudinal and radial characteristics of intra-anal pressures in children using 3D high-definition anorectal manometry: new observations. Am J Gastroenterol. 2013 Dec;108(12):1918-28. doi: 10.1038/ajg.2013.361. Epub 2013 Oct 29.
- Background: PubMed 17023769Ozkose Z, Demir FS, Pampal K, Yardim S. Hemodynamic and anesthetic advantages of dexmedetomidine, an alpha 2-agonist, for surgery in prone position. Tohoku J Exp Med. 2006 Oct;210(2):153-60. doi: 10.1620/tjem.210.153.
- Background: PubMed 16803911Gurbet A, Basagan-Mogol E, Turker G, Ugun F, Kaya FN, Ozcan B. Intraoperative infusion of dexmedetomidine reduces perioperative analgesic requirements. Can J Anaesth. 2006 Jul;53(7):646-52. doi: 10.1007/BF03021622.
- Background: PubMed 21461792Pestieau SR, Quezado ZM, Johnson YJ, Anderson JL, Cheng YI, McCarter RJ, Choi S, Finkel JC. High-dose dexmedetomidine increases the opioid-free interval and decreases opioid requirement after tonsillectomy in children. Can J Anaesth. 2011 Jun;58(6):540-50. doi: 10.1007/s12630-011-9493-7. Epub 2011 Apr 2.
- Background: PubMed 24722260Le Guen M, Liu N, Tounou F, Auge M, Tuil O, Chazot T, Dardelle D, Laloe PA, Bonnet F, Sessler DI, Fischler M. Dexmedetomidine reduces propofol and remifentanil requirements during bispectral index-guided closed-loop anesthesia: a double-blind, placebo-controlled trial. Anesth Analg. 2014 May;118(5):946-55. doi: 10.1213/ANE.0000000000000185.
- Background: PubMed 12827005Morera C, Nurko S. Rectal manometry in patients with isolated sacral agenesis. J Pediatr Gastroenterol Nutr. 2003 Jul;37(1):47-52. doi: 10.1097/00005176-200307000-00008.
- Background: PubMed 24163449Sen S, Chakraborty J, Santra S, Mukherjee P, Das B. The effect of dexmedetomidine infusion on propofol requirement for maintenance of optimum depth of anaesthesia during elective spine surgery. Indian J Anaesth. 2013 Jul;57(4):358-63. doi: 10.4103/0019-5049.118558.
- Background: PubMed 19952754Al-Zaben KR, Qudaisat IY, Al-Ghanem SM, Massad IM, Al-Mustafa MM, Al-Oweidi AS, Abu-Halaweh SA, Abu-Ali HM, Saleem MM. Intraoperative administration of dexmedetomidine reduces the analgesic requirements for children undergoing hypospadius surgery. Eur J Anaesthesiol. 2010 Mar;27(3):247-52. doi: 10.1097/EJA.0b013e32833522bf.
- Background: PubMed 18363626Mason KP, Zurakowski D, Zgleszewski SE, Robson CD, Carrier M, Hickey PR, Dinardo JA. High dose dexmedetomidine as the sole sedative for pediatric MRI. Paediatr Anaesth. 2008 May;18(5):403-11. doi: 10.1111/j.1460-9592.2008.02468.x. Epub 2008 Mar 18.
- Background: PubMed 16790626Mason KP, Zgleszewski SE, Dearden JL, Dumont RS, Pirich MA, Stark CD, D'Angelo P, Macpherson S, Fontaine PJ, Connor L, Zurakowski D. Dexmedetomidine for pediatric sedation for computed tomography imaging studies. Anesth Analg. 2006 Jul;103(1):57-62, table of contents. doi: 10.1213/01.ane.0000216293.16613.15.
- Background: PubMed 19020127Heard C, Burrows F, Johnson K, Joshi P, Houck J, Lerman J. A comparison of dexmedetomidine-midazolam with propofol for maintenance of anesthesia in children undergoing magnetic resonance imaging. Anesth Analg. 2008 Dec;107(6):1832-9. doi: 10.1213/ane.0b013e31818874ee.
- Individual participant dataSharing planned: No
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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.
Keira Mason, MD principal investigator
Boston Children's Hospital
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 in people with Anesthesia, run by Boston Children's Hospital 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 5 inclusion and 16 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 26 Apr 2024. 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 26 Apr 2024). 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?
Intra-anal Sphincter Pressure (IASP) 1 Minute After Dexmedetomidine Administration (time frame: 1 minute). 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 NCT04798482, which also lists 22 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 26 Apr 2024.