Hemodynamic Changes During Implant Surgery With Intravenous Conscious Sedation

Blood Pressure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05756439
• Other study ID #: HUM00172521
• Status: Completed
• Start date: February 3, 2022
• Est. completion date: May 26, 2022

Study information

• Verified date: February 2023
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: May 26, 2022
• Est. primary completion date: May 26, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Blood Pressure
• Dental Anxiety

Intervention

Drug:
• Intravenous Sedatives with or Without Analgesia
Participants having dental surgery with conscious intravenous sedation

Locations

Country	Name	City	State
United States	University of Michigan School of Dentistry	Ann Arbor	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
University of Michigan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	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.
Primary	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	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
Secondary	Patient Satisfaction	Patient satisfaction with surgery. Minimum score 6, maximum score 30 with higher scores indicating greater satisfaction.	2 weeks after surgery