Hemodynamic Changes During Implant Surgery with Intravenous Conscious Sedation

NCT05756439 | Completed

• 1 other identifier: HUM00172521
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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

Conditions

Blood Pressure; Dental Anxiety

Keywords

Dental surgery; intravenous sedation

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (2)

• Dental Anxiety Scale

  Baseline

• Patient Satisfaction

  2 weeks after surgery

Study Arms (2)

Control

Participants having dental surgery

Drug: No IV sedation

Intravenous sedation

Participants having dental surgery

Drug: Intravenous Sedatives with or Without Analgesia

Interventions

Intravenous Sedatives with or Without Analgesia DRUG

Participants having dental surgery with conscious intravenous sedation

Also known as: conscious iv sedation

Intravenous sedation

No IV sedation DRUG

Participants having dental surgery without conscious intravenous sedation

Also known as: no conscious iv sedation

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects scheduled for dental surgery with or without intravenous sedation.

You may qualify if:

• Be ≥ 18 years of age
• Need dental implant/periodontal surgery with or without IV sedation (up to a maximum of 4 implants)

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Michigan: lead

Study Sites (1)

University of Michigan School of Dentistry

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Interventions

Analgesia

Intervention Hierarchy (Ancestors)

Anesthesia and Analgesia

Study Officials

• Hom-Lay Wang, DDS MSD PhD

  Department of Periodontics and Oral Medicine University of Michigan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Collegiate Professor of Periodontics and Professor of Dentistry

Study Record Dates

• First Submitted: February 2, 2023
• First Posted: March 6, 2023
• Study Start: February 3, 2022
• Primary Completion: May 26, 2022
• Study Completion: May 26, 2022
• Last Updated: September 25, 2024

Record last verified: 2023-02

Locations

US (1)