Efficacy of single dose intranasal dexmedetomidine for conscious sedation in dental practice in dentophobic uncooperative patients with intellectual disability.

Phase 2

Completed

Conditions: dentophobia
10002861
Verstandelijke beperking
fear for dentist

Registration Number: NL-OMON43058

Lead Sponsor: niversitair Medisch Centrum Groningen

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 30

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>* Proportion of patients in whom dental treatment under procedural sedation<br /><br>with intranasal dexmedetomidine can be finished and is not terminated because<br /><br>of inadequate sedation.<br /><br>* Proportion of patients in whom dental treatment under general anesthesia can<br /><br>be finished and is not terminated because of inadequate sedation.<br /><br>* mRASS-score at specified dental treatment events after dexmedetomidine<br /><br>treatment compared to agitation score descriptor from the non-pharmacological<br /><br>Trial-of-Treatment<br /><br>* mRASS-score at specified events during induction for general anesthesia<br /><br>compared to agitation score descriptor from the non-pharmacological<br /><br>Trial-of-Treatment</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>* Tolerance (mRASS) of achieving venous access when general anesthesia is<br /><br>indicated<br /><br>* Ease of induction when general anesthesia is indicated as measured by RASS<br /><br>during induction</p><br>