To demonstrate non-inferiority of conscious sedation with intranasal dexmedetomidine for performing dental care in patients with intellectual disability and dentophobia.
ID
Source
Brief title
Condition
- Other condition
- Anxiety disorders and symptoms
Synonym
Health condition
Verstandelijke beperking
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
* Proportion of patients in whom dental treatment under procedural sedation
with intranasal dexmedetomidine can be finished and is not terminated because
of inadequate sedation.
* Proportion of patients in whom dental treatment under general anesthesia can
be finished and is not terminated because of inadequate sedation.
* mRASS-score at specified dental treatment events after dexmedetomidine
treatment compared to agitation score descriptor from the non-pharmacological
Trial-of-Treatment
* mRASS-score at specified events during induction for general anesthesia
compared to agitation score descriptor from the non-pharmacological
Trial-of-Treatment
Secondary outcome
* Tolerance (mRASS) of achieving venous access when general anesthesia is
indicated
* Ease of induction when general anesthesia is indicated as measured by RASS
during induction
Background summary
Many patients with intellectual disability (PwIDs) lack adequate cognitive
strategies to cope with the stress and fear accompanying medical or dental
treatment. This makes surgical or dental procedures for these patients
stressful if not impossible to tolerate without general anesthesia. Although
general anesthesia provides the certainty of good access to the patient, the
workup, induction and emergence of general anesthesia is often even more
stressful for this vulnerable group of patients. Safe and reliable sedation
with a quick and easy route of administration can provide patient comfort and
ensure good cooperation and access. It would also mean these patients can be
treated in office- or home based settings, negating the need for several
hospital visits.
Intranasal administration of dexmedetomidine has been proven to be quick,
comfortable and reliable in providing dose dependent sedation levels ranging
from premedicative anxiolysis to deep conscious sedation. The literature only
bases these conclusions on studies in adults with full cognitive function or
children. Theoretically dexmedetomidine may provide an excellent alternative to
more commonly used sedatives like benzodiazepines. Dexmedetomidine*s
sympathicolytic effect can alleviate fear not by suppressing the cerebral
projection of fear but by reducing the intrinsic activity of the brainstem
arousal system and of the autonomous nervous system. Especially for patients
without the cognitive coping abilities this may provide good and safe sedation.
Study objective
To demonstrate non-inferiority of conscious sedation with intranasal
dexmedetomidine for performing dental care in patients with intellectual
disability and dentophobia.
Study design
A single center randomized therapeutic non-inferiority study
Intervention
Patients for whom consent has been obtained will already have completed a
treatment in the Specialized dentistry department to complete dental treatment
without pharmacological support. The indication for treatment under general
anesthesia comes from the failure to complete this treatment. These patients
have an indication for treatment under general anesthesia. Participants are
randomized 1:1 to receive either standard treatment ( general anesthesia) or
treatment under procedural sedation ( dexmedetomidine)
After randomization for treatment under general anesthesia,the normal procedure
is followed for induction of general anesthesia. After randomization for
treatment with dexmedetomidine a single dose dexmedetomidine is given
intranasally by atomizer device. After a latency period of 20-30 the planned
dental treatment will start.
For both treatment groups, a modified mRASS score is noted during the
treatment. The stages of this score have been rafted by dentists of the Special
dentistry department of the UMCG en have been matched to stages of induction of
general anesthesia with similar levels of confrontation. For the general
anesthesia group the mRASS is noted during induction of general anesthesia. For
the dexmedetomidine group the mRASS is noted during dental treatment.
The mRASS score is a specialized modificiton of the well recognized RASS score.
The scores descriptors have been modified to describe clinical signs of
agitation and sedation fitting the events of dental treatment. When mRASS
scores supersede the pre-treatment mRASS scores form the policlinic phase
continuation of treatment under dexmedetomidine sedation is longer deemed to be
in the best interest of the patient and a conversion to general anesthesia is
initiated after which planned dental treatment can be finished.
In accordance with the Code of Conduct "Verzet bij mensen met een
verstandelijke handicap in het kader van de Wet Medisch-Wetenschappelijk
Onderzoek met Mensen" guardian of the patient will be present to observe the
tolerance of treatment and to inform the dentist and the researcher when the
reaction of the patient is notably different or more excessive from reactions
typical to the patient when encoutering other abnormal situation.
Study burden and risks
Participation in the study can provide several benefits to the patients. When
treatment under sedation is well tolerable, they will be spared the stressfull
events of an induction of general anesthesia. When the treatment is not
tolerable, the anxiolytic properties of dexmedetomidine have a calming effect
which will make the events of the induction of general anesthesia more
beareable.
This is a therapeutic trial. Participation can have several benefits to
patients. Participants in the therapeutic arm ( sedation) will receive their
planned treatment even when the treatment under sedation is not tolerable to
them.
When mRASS scores supersede the pre-treatment mRASS scores form the policlinic
phase continuation of treatment under dexmedetomidine sedation is longer deemed
to be in the best interest of the patient and a conversion to general
anesthesia is initiated after which planned dental treatment can be finished.
All clinicians and researchers involvoed will act in accordance with the Code
of Conduct "Verzet bij mensen met een verstandelijke handicap
in het kader van de Wet Medisch-Wetenschappelijk Onderzoek met Mensen." A
guardian of the patient will be present to observe the tolerance of treatment
and to inform the dentist and the researcher when the reaction of the patient
is notably different or more excessive from reactions typical to the patient
when encoutering other abnormal situations.
The presence of a dedicated anaesthesiologist will be constant during the study
period in which dexmedetomidine is used. The sedation with dexmedetomidine has
no implications for general anesthesia (should this be indicated) that can not
easily be accommodated for by the attending anesthetic team.
No follow up visits are required.
Hanzeplein 1
Groningen 9700RB
NL
Hanzeplein 1
Groningen 9700RB
NL
Listed location countries
Age
Inclusion criteria
1. Intellectual Disability of DSM-V classes Mild to Profound
2. Documented failure to tolerate the indicated dental treatment with non-pharmacological support.
3. Indication for dental treatment under general anesthesia because of 1 and 2.
4. Completed and cleared through the pre-anesthetic screening for general anesthesia as per the standard protocol of the UMCGs department of anesthesiology
5. Adult, men and women, 18-55 years of age, inclusive.
6. Body Mass Index (BMI) * 17.5 and * 35 kg/m2, inclusive, and a total body weight >50 kg, at screening and check-in.
7. American Society of Anesthesiologists (ASA) Physical Status 1-3
8. Able to understand the study procedures as described in the patient information sheet, willing and able to comply with the protocol, and to provide written informed consent OR in the case of legal incapability: a guardian understanding the study procedures as described in the patient information sheet, provides written informed consent.
Exclusion criteria
1. Contraindications for the use of dexmedetomidine
2. Known intolerance to dexmedetomidine
3. History or presence of significant cardiovascular disease (ASA >3), or significant cardiovascular disease risk factors, significant coronary artery disease, or any known genetic pre disposition to cardiac arrhythmia (including long QT syndrome.)
4. History or presence of significant (ASA >3) pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, neurological disease.
5. History of any illness or medication use that, in the opinion of the PI, might confound the results of the study or pose an additional risk to the subject by their participation in the study.
6 difficult airway management excpected by the attendind anesthesiologist
7. Surgery within the past 90 days prior to dosing judged by the PI to be clinically relevant.
8. History of febrile illness within 5 days prior to dosing.
9. History or presence of alcoholism or drug abuse within the past 2 years.
10. Hypersensitivity or idiosyncratic reaction to components of dexmedetomidine, , or to compounds related to the study medications.
11. Patients refusal or, in case of legal incapability:
12. Guardians refusal
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2016-001567-37-NL |
| CCMO | NL57519.042.16 |