Efficacy of dexmedetomidine for conscious sedation during dental treatement of uncooperative patients with intellectual disability and fear of dentists.

Phase 1

Conditions: dentophobiaintellectual disability
Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]

Registration Number: EUCTR2016-001567-37-NL

Lead Sponsor: niversity Medical Center Groningen

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

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 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.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 30
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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.Difficulty in airway management anticipated by the attending 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