Hemodynamic Changes During Implant Surgery with Intravenous Conscious Sedation

Hemodynamic Changes During Implant Surgery with Intravenous Conscious Sedation: a Clinical Prospective Study

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

Study Overview

• Status: Completed
• Conditions: Blood Pressure; Dental Anxiety
• Intervention / Treatment: Drug: Intravenous Sedatives with or Without Analgesia; Drug: No IV sedation

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 Type: Observational
• Enrollment (Actual): 50

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan School of Dentistry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Subjects scheduled for dental surgery with or without intravenous sedation.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Control; Participants having dental surgery	Drug: No IV sedation; Participants having dental surgery without conscious intravenous sedation; Other Names: no conscious iv sedation
Intravenous sedation; Participants having dental surgery	Drug: Intravenous Sedatives with or Without Analgesia; Participants having dental surgery with conscious intravenous sedation; Other Names: conscious iv sedation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Patient Satisfaction	Patient satisfaction with surgery. Minimum score 6, maximum score 30 with higher scores indicating greater satisfaction.	2 weeks after surgery

Collaborators and Investigators

• Sponsor: University of Michigan
• Investigators: Principal Investigator: Hom-Lay Wang, DDS MSD PhD, Department of Periodontics and Oral Medicine University of Michigan

Study record dates

Study Major Dates

• Study Start (Actual): February 3, 2022
• Primary Completion (Actual): May 26, 2022
• Study Completion (Actual): May 26, 2022

Study Registration Dates

• First Submitted: February 2, 2023
• First Submitted That Met QC Criteria: February 23, 2023
• First Posted (Actual): March 6, 2023

Study Record Updates

• Last Update Posted (Actual): September 25, 2024
• Last Update Submitted That Met QC Criteria: September 23, 2024
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: Dental surgery; intravenous sedation
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Hypnotics and Sedatives
• Other Study ID Numbers: HUM00172521

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No