Hemodynamic Changes During Implant Surgery With Intravenous Conscious Sedation

Completed

• Conditions: Blood Pressure; Dental Anxiety
• Interventions: Drug: No IV sedation; Drug: Intravenous Sedatives with or Without Analgesia

• Registration Number: NCT05756439
• Lead Sponsor: University of Michigan

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.

Study Timeline

• Study Start: 2022-02-03
• Primary Completion: 2022-05-26
• Study Completion: 2022-05-26
• Status Verified: 2023-02
• Study First Submitted: 2023-02-02
• Study First Submitted QC: 2023-02-23
• Last Update Submitted: 2023-02-23
• Study First Posted: 2023-03-06
• Last Update Posted: 2023-03-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Control	No IV sedation	Participants having dental surgery
Intravenous sedation	Intravenous Sedatives with or Without Analgesia	Participants having dental surgery

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Patient Satisfaction	2 weeks after surgery	Patient satisfaction with surgery. Minimum score 6, maximum score 30 with higher scores indicating greater satisfaction.
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.

Trial Locations

Locations (1)

University of Michigan School of Dentistry; 🇺🇸 Ann Arbor, Michigan, United States