Blood Pressure, Dental Anxiety
Conditions
Keywords
Dental surgery, intravenous sedation
Brief summary
The goal of this study is to determine whether intravenous sedation would contribute to the stabilization of hemodynamics in adult patients during periodontal/implant surgery compared to receiving local anesthesia during periodontal/implant surgery
Detailed description
Monitoring is the global method of observation and data recording in relation to body organ and system function that afford constant information to ensure continuous evaluation of the patient's physical condition. The aim of this study is to determine whether intravenous sedation would contribute to the stabilization of hemodynamics in adult patients during dental surgery. Secondary, patient related outcome will be evaluated by a questionnaire to determine the patients' perception, acceptance and comfort during intravenous sedation after assessing the influence of patients' preoperative anxiety. 50 subjects who need implant/periodontal surgery at the University of Michigan School of Dentistry will be recruited for this study.
Interventions
Participants having dental surgery with conscious intravenous sedation
DRUGNo IV sedation
Participants having dental surgery without conscious intravenous sedation
Sponsors
University of Michigan
Study design
Observational model
COHORT
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Be ≥ 18 years of age * Need dental implant/periodontal surgery with or without IV sedation (up to a maximum of 4 implants)
Exclusion criteria
* You have any reason you cannot comply with the study protocol * You take any medication that may influence hemodynamic changes including anxiolytic medication (last intake \<48 hours before intervention) as well as pain medication (last intake \<48 hours before intervention) * Pregnant or unsure of pregnancy (self-reported)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in blood pressure (systolic) | At the start of surgery and every 15 minutes until the surgery is over, up to 4 hours. | Systolic blood pressure will be recorded throughout the surgical procedure |
| Change in blood pressure (diastolic) | At the start of surgery and every 15 minutes until the surgery is over, up to 4 hours. | Diastolic blood pressure will be recorded throughout the surgical procedure |
| Change in heart rate | At the start of surgery and every 15 minutes until the surgery is over, up to 4 hours. | Heart rate will be recorded throughout the surgical procedure |
| Change in oxygen saturation | At the start of surgery and every 15 minutes until the surgery is over, up to 4 hours. | Oxygen saturation will be recorded throughout the surgical procedure |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Dental Anxiety Scale | Baseline | Evaluation of dental anxiety using Corah's Dental Anxiety Scale. Minimum score 4, maximum score 20 with higher scores indicating greater dental anxiety. |
| Patient Satisfaction | 2 weeks after surgery | Patient satisfaction with surgery. Minimum score 6, maximum score 30 with higher scores indicating greater satisfaction. |
Countries
United States
Outcome results
None listed