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NCT Number: NCT05756439

Hemodynamic Changes During Implant Surgery with Intravenous Conscious Sedation

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

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Key information

Conditions

Blood Pressure Dental Anxiety

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Michigan School of Dentistry

Ann Arbor, Michigan, 48109, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Intravenous Sedatives with or Without Analgesia

Drug

Participants having dental surgery with conscious intravenous sedation

Other names: conscious iv sedation

No IV sedation

Drug

Participants having dental surgery without conscious intravenous sedation

Other names: no conscious iv sedation

Primary outcomes

  1. Change in blood pressure (systolic)

    Time frame: 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

  2. Change in blood pressure (diastolic)

    Time frame: 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

  3. Change in heart rate

    Time frame: 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

  4. Change in oxygen saturation

    Time frame: 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 outcomes

  1. Dental Anxiety Scale

    Time frame: Baseline

    Evaluation of dental anxiety using Corah's Dental Anxiety Scale. Minimum score 4, maximum score 20 with higher scores indicating greater dental anxiety.

  2. Patient Satisfaction

    Time frame: 2 weeks after surgery

    Patient satisfaction with surgery. Minimum score 6, maximum score 30 with higher scores indicating greater satisfaction.

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Mar 6, 2023
Registry last updated
Sep 25, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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