Hemodynamic Changes During Implant Surgery With Intravenous Conscious Sedation

Study Overview
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Brief Summary
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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
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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.

Official Title
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Hemodynamic Changes During Implant Surgery With Intravenous Conscious Sedation: A Clinical Prospective Study

Conditions
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Blood Pressure, Dental Anxiety

Intervention / Treatment
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* Drug: Intravenous Sedatives with or Without Analgesia


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Control<br>Participants having dental surgery | |
| Intravenous sedation<br>Participants having dental surgery | Drug: Intravenous Sedatives with or Without Analgesia<br>* Participants having dental surgery with conscious intravenous sedation<br>* Other names: conscious iv sedation;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in blood pressure (systolic) | Systolic blood pressure will be recorded throughout the surgical procedure | At the start of surgery and every 15 minutes until the surgery is over, up to 4 hours. | 
| Change in blood pressure (diastolic) | Diastolic blood pressure will be recorded throughout the surgical procedure | At the start of surgery and every 15 minutes until the surgery is over, up to 4 hours. | 
| Change in heart rate | Heart rate will be recorded throughout the surgical procedure | At the start of surgery and every 15 minutes until the surgery is over, up to 4 hours. | 
| Change in oxygen saturation | Oxygen saturation will be recorded throughout the surgical procedure | At the start of surgery and every 15 minutes until the surgery is over, up to 4 hours. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dental Anxiety Scale | Evaluation of dental anxiety using Corah's Dental Anxiety Scale. Minimum score 4, maximum score 20 with higher scores indicating greater dental anxiety. | Baseline | 
| Patient Satisfaction | Patient satisfaction with surgery. Minimum score 6, maximum score 30 with higher scores indicating greater satisfaction. | 2 weeks after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dental surgery, intravenous sedation