Clinical trial NCT05756439: Hemodynamic Changes During Implant Surgery with Intravenous Conscious Sedation
Official title: Hemodynamic Changes During Implant Surgery with Intravenous Conscious Sedation: a Clinical Prospective Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Blood Pressure
Dental Anxiety
Keywords: Dental surgery
intravenous sedation
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2023-03-06
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects scheduled for dental surgery with or without 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Change in blood pressure (systolic)
timeFrame: At the start of surgery and every 15 minutes until the surgery is over, up to 4 hours.
measure: Change in blood pressure (diastolic)
timeFrame: At the start of surgery and every 15 minutes until the surgery is over, up to 4 hours.
measure: Change in heart rate
timeFrame: At the start of surgery and every 15 minutes until the surgery is over, up to 4 hours.
measure: Change in oxygen saturation
timeFrame: At the start of surgery and every 15 minutes until the surgery is over, up to 4 hours.
Secondary outcomes:
measure: Dental Anxiety Scale
timeFrame: Baseline
measure: Patient Satisfaction
timeFrame: 2 weeks after surgery
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan School of Dentistry
state: Michigan
Study officials:
affiliation: Department of Periodontics and Oral Medicine University of Michigan
name: Hom-Lay Wang, DDS MSD PhD
role: PRINCIPAL_INVESTIGATOR
References: