Blood PressureNCT05756439
Hemodynamic Changes During Implant Surgery with Intravenous Conscious Sedation
An observational study of Blood Pressure and Dental Anxiety, run by University of Michigan at 1 site in United States.
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 Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Blood Pressure, Dental Anxiety
- What is being tested?
- Intravenous Sedatives with or Without Analgesia and No IV sedation
- Type of treatment
- Injection or infusion
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Feb 2022to 26 May 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Subjects scheduled for dental surgery with or without intravenous sedation.
Who may be able to join
- Be ≥ 18 years of age
- Need dental implant/periodontal surgery with or without IV sedation (up to a maximum of 4 implants)
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Michigan School of Dentistry
Ann Arbor, Michigan, 48109
About this study
Official title: 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
Read the 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.
- Conditions
- Blood Pressure, Dental Anxiety
- Being tested
- Intravenous Sedatives with or Without Analgesia, No IV sedation
- Keywords
- Dental surgery, intravenous sedation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intravenous Sedatives with or Without AnalgesiaDrug
Also called conscious iv sedation
Participants having dental surgery with conscious intravenous sedation
No IV sedationDrug
Also called no conscious iv sedation
Participants having dental surgery without conscious intravenous sedation
| Study group | Role | What they receive |
|---|---|---|
| Control | Participants having dental surgery Receives: Drug: No IV sedation | |
| Intravenous sedation | Participants having dental surgery Receives: Drug: Intravenous Sedatives with or Without Analgesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in blood pressure (systolic)
Systolic blood pressure will be recorded throughout the surgical procedure
Measured: 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
Measured: 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
Measured: 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
Measured: At the start of surgery and every 15 minutes until the surgery is over, up to 4 hours.
Secondary outcomes (2)
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.
Measured: Baseline
Patient Satisfaction
Patient satisfaction with surgery. Minimum score 6, maximum score 30 with higher scores indicating greater satisfaction.
Measured: 2 weeks after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2023
- Study start3 Feb 2022
- Primary completion26 May 2022
- Study completion26 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blood PressureStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hom-Lay Wang, DDS, MSD, Ph D, University of Michigan
- Investigators
- Hom-Lay Wang, DDS MSD PhD, Principal investigator, Department of Periodontics and Oral Medicine University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05756439
- Sponsor's protocol ID
- HUM00172521
- Status last verified
- Feb 2023
- First submitted
- 2 Feb 2023
- Last updated
- 25 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hemodynamic Changes During Implant Surgery with Intravenous Conscious Sedation: a Clinical Prospective Study
- ClinicalTrials.gov ID
- NCT05756439
- Acronym / sponsor ID
- HUM00172521
- Conditions
- Blood Pressure, Dental Anxiety
- Keywords
- Dental surgery, intravenous sedation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Study start
- 3 Feb 2022 (actual)
- Primary completion
- 26 May 2022 (actual)
- Study completion
- 26 May 2022 (actual)
- First posted
- 6 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | – | Drug: No IV sedationParticipants having dental surgery |
| Intravenous sedation | – | Drug: Intravenous Sedatives with or Without AnalgesiaParticipants having dental surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects scheduled for dental surgery with or without intravenous sedation.
Key inclusion criteria (2 listed)
- Be ≥ 18 years of age
- Need dental implant/periodontal surgery with or without IV sedation (up to a maximum of 4 implants)
Key exclusion criteria (3 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intravenous Sedatives with or Without AnalgesiaAlso: conscious iv sedationParticipants having dental surgery with conscious intravenous sedation | Drug | Intravenous sedation |
| No IV sedationAlso: no conscious iv sedationParticipants having dental surgery without conscious intravenous sedation | Drug | Control |
Primary outcome
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
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
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
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
2 secondary outcomes
Dental Anxiety Scale
Time frame: Baseline
Patient Satisfaction
Time frame: 2 weeks after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hom-Lay Wang, DDS MSD PhD principal investigator
Department of Periodontics and Oral Medicine University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Blood Pressure and Dental Anxiety, run by University of Michigan at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2024.