Hemodynamic Changes During Implant Surgery with Intravenous Conscious Sedation

University of Michigan50 enrolled

Overview

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

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Blood Pressure Dental Anxiety

Interventions

Intravenous Sedatives with or Without AnalgesiaDRUG

Participants having dental surgery with conscious intravenous sedation

No IV sedationDRUG

Participants having dental surgery without conscious intravenous sedation

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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)

Locations (1)

University of Michigan School of Dentistry

Ann Arbor, Michigan, United States

Outcomes

Primary Outcomes

Change in blood pressure (systolic)

Systolic blood pressure will be recorded throughout the surgical procedure

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: At the start of surgery and every 15 minutes until the surgery is over, up to 4 hours.

Secondary Outcomes

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.

Time frame: Baseline

Patient Satisfaction

Patient satisfaction with surgery. Minimum score 6, maximum score 30 with higher scores indicating greater satisfaction.

Time frame: 2 weeks after surgery

Data from ClinicalTrials.gov

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