Conscious sedation for procedures in Dental and Minor Maxillofacial Surgery Unit: optimization of the dexmedetomidine dose (Dexdor®).

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2014-002243-17-ES

Enrollment

124

Registered

2014-06-09

Start date

2014-10-24

Completion date

Unknown

Last updated

2020-06-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sedation for procedures in Dental and Minor Maxillofacial Surgery Unit MedDRA version: 17.0 Level: PT Classification code 10054806 Term: Maxillofacial operation System Organ Class: 10042613 - Surgical and medical procedures

Interventions

Trade Name: Dexdor Product Name: Dexdor Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: DEXMEDETOMIDINE CAS Number: 113775-47-6 Concentration unit: mg/kg/h milligram(s)

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Ability to provide informed consent and express his desire to meet all protocol requirements during the study. 2. The patient should be able to meet with all requirements of the clinical trial. 3. Above 18 years of age. 4. A pregnancy test will be performed to women between 18 years old and menopause in order to rule out pregnancy unknown. 5. The patient requires sedation to carry out one of the Dental procedures and Maxillofacial Surgery Unit: Complex wisdom 4 tooth extraction, Dental implants with or without bone stimulation. 6. Individuals ASA I (healthy patient) or II (patient with a process mild systemic without limitations in daily activities.) 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 34 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 90

Exclusion criteria

Exclusion criteria: 1. Dexmedetomidine hypersensitivity 2. HR 45bpm does not shows sign of low cardiac output, he will be considered candidates for the study. 3. Heart block grade 2-3 without pacemaker 4. Mean blood pressure < 60mmHg. 5. Severe stroke. 6. Pregnancy and breastfeeding

Design outcomes

Primary

Measure	Time frame
Main Objective: To evaluate the need of administering a loading dose of dexmedetomidine (Dexdor®) to obtain an adequate level of sedation, BIS 85-90 after 30min of drug administration and BIS 80-85 after 45min, for ambulant procedures in the Dental and Minor Maxillofacial Surgery Unit.;Secondary Objective: - To evaluate the optimal maintenance dose of dexmedetomidine to achieve a satisfactory sedation during the procedure - To perform a comparative analysis of possible hemodynamic changes (reflex bradycardia, hypertension...) depending on the administration of a loading dose - To compare degrees of satisfaction, using questionnaires for the patient and the interventionist, about the administration of a loading dose and the maintenance dose administered - To establish a relationship between the administration of the loading and maintenance dose with BIS levels observed during the procedure. - To evaluate surgical stress index (SSI) during the procedure. - To describe possible adverse or secondary effects during the use of dexmedetomidine for this type of interventions - To evaluate the influence of the loading and maintenance doses on the time until discharge.;Primary end point(s): - Administered loading dose: 0.5 µg kg-1, 0.2 µg kg-1 or placebo. - Dexmedetomidine concentration required during the intervention to obtain an adequate level of sedation BIS 85-90 after 30min of drug administration, and BIS 80-85 after 45min, for ambulant procedures in the Dental and Minor Maxillofacial Surgery Unit.;Timepoint(s) of evaluation of this end point: - When administering the loading dose. - After 30 min of the loading dose administration to reach a BIS 85-90 and 45 min from the start of the procedure to reach a BIS between 80-85.	—

Measure

Time frame

Main Objective: To evaluate the need of administering a loading dose of dexmedetomidine (Dexdor®) to obtain an adequate level of sedation, BIS 85-90 after 30min of drug administration and BIS 80-85 after 45min, for ambulant procedures in the Dental and Minor Maxillofacial Surgery Unit.;Secondary Objective: - To evaluate the optimal maintenance dose of dexmedetomidine to achieve a satisfactory sedation during the procedure - To perform a comparative analysis of possible hemodynamic changes (reflex bradycardia, hypertension...) depending on the administration of a loading dose - To compare degrees of satisfaction, using questionnaires for the patient and the interventionist, about the administration of a loading dose and the maintenance dose administered - To establish a relationship between the administration of the loading and maintenance dose with BIS levels observed during the procedure. - To evaluate surgical stress index (SSI) during the procedure. - To describe possible adverse or secondary effects during the use of dexmedetomidine for this type of interventions - To evaluate the influence of the loading and maintenance doses on the time until discharge.;Primary end point(s): - Administered loading dose: 0.5 µg kg-1, 0.2 µg kg-1 or placebo. - Dexmedetomidine concentration required during the intervention to obtain an adequate level of sedation BIS 85-90 after 30min of drug administration, and BIS 80-85 after 45min, for ambulant procedures in the Dental and Minor Maxillofacial Surgery Unit.;Timepoint(s) of evaluation of this end point: - When administering the loading dose. - After 30 min of the loading dose administration to reach a BIS 85-90 and 45 min from the start of the procedure to reach a BIS between 80-85.

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Secondary

Measure	Time frame
Secondary end point(s): 1. Demographic variables (sex, age, weight, BMI) 2. Patient-associated pathology (diabetes mellitus, hypertension, ischemic cardiopathy,...) 3. Type of performed procedure 4. Reasons for changing the maintenance dose 5. Monitored vital signs: cardiac frequency, blood pressure, respiratory frequency, EtCO2; SpO2. 6. Degree of analgesia obtained: SSI (surgical stress index) 7. Duration of the procedure. 8. Intra- and post-operative events: severe bradycardia (< 40bpm), syncopes, hypotensive episodes, nausea, ... 9. Recovery time and time until discharge. 10. Degree of patient satisfaction, using assessment questionnaire. To assess the degree of patient satisfaction after use of dexmedetomidine, in procedures of the Dental and Minor Maxillofacial Surgery Unit, we have adapted with minimal changes a questionnaire previously validated in a study on the effectiveness of midazolam for sedation in flexible bronchoscopy. 11. Degree of satisfaction of the surgical team, using assessment questionnaire.;Timepoint(s) of evaluation of this end point: At different times throughout the study.	—

Measure

Time frame

Secondary end point(s): 1. Demographic variables (sex, age, weight, BMI) 2. Patient-associated pathology (diabetes mellitus, hypertension, ischemic cardiopathy,...) 3. Type of performed procedure 4. Reasons for changing the maintenance dose 5. Monitored vital signs: cardiac frequency, blood pressure, respiratory frequency, EtCO2; SpO2. 6. Degree of analgesia obtained: SSI (surgical stress index) 7. Duration of the procedure. 8. Intra- and post-operative events: severe bradycardia (< 40bpm), syncopes, hypotensive episodes, nausea, ... 9. Recovery time and time until discharge. 10. Degree of patient satisfaction, using assessment questionnaire. To assess the degree of patient satisfaction after use of dexmedetomidine, in procedures of the Dental and Minor Maxillofacial Surgery Unit, we have adapted with minimal changes a questionnaire previously validated in a study on the effectiveness of midazolam for sedation in flexible bronchoscopy. 11. Degree of satisfaction of the surgical team, using assessment questionnaire.;Timepoint(s) of evaluation of this end point: At different times throughout the study.

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Countries

Spain

Contacts

Public ContactUCICEC

Clinica Universidad de Navarra

ucicec@unav.es34948255 4001144

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026