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Third Molars ExtractionPREPARENCT06873152

Improvement of Operating Room Efficiency in Bilateral Wisdom Teeth Surgery

A study testing Advanced preoperative program in people with Third Molars Extraction, run by Jessa Hospital at 1 site in Belgium.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study aims to assess and compare the implementation of this comprehensive program in patients undergoing bilateral third molar extraction on OR and hospital efficiency and patient experience. Read more about this study

Who is it for?
Ages 16 to 60 years
Conditions the study is for
Third Molars Extraction
What is being tested?
Advanced preoperative program
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
130 participants
Where
1 siteBelgium
Study dates
10 Mar 2025to 27 May 2025
Phase
Interventional
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 16 to 60 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • Age: 16-60 years
  • ASA I- III
  • BMI ≤ 40 kg/m2
  • Patient is willing to give informed consent
  • Patient is scheduled for wisdom teeth surgery

Who cannot join

  • The inability to understand to the study design
  • Refusal to participate in the trial

Trial locations and contacts

1 site in 1 country.

Belgium1 site
  • Jessa Hospital

    Hasselt, Limburg, 3500

Other trials in Belgium

About this study

Official title: Improvement of Operating Room Efficiency in the Extraction of Bilateral Third Molar Surgery Under Narcosis Using Enhanced Preoperative Preparation and a Dedicated Operating Room Team: a Randomised Controlled Trial (PREPARE-study)

This study aims to assess and compare the implementation of this comprehensive program in patients undergoing bilateral third molar extraction on OR and hospital efficiency and patient experience. The investigators hypothesize that this comprehensive program will be superior in terms of OR efficiency compared to "business as usual".

Read the detailed description

Operating room (OR) efficiency is an important parameter for hospital cost-efficiency since the OR is a high-cost unit. Time is the most valuable resource of an OR. For example, in fiscal year 2014 for California's acute care hospitals, cost attributable to fixed overhead to utilize an OR was an estimated $20 per minute. When factoring in physician and nursing staff, the mean cost of operating room time in the ambulatory setting was $36 per minute.

In that regard, the nonoperative time (NOT) defined as the time between surgical completion of the previous patient and skin incision on the following patient is an important parameter. The NOT can be calculated as the sum of Anesthesia induction time (IT), the emergence time (ET), and the turnover time (TOT) and has the potential to improve or reduce operating room efficiency substantially, especially in short-duration surgery programs. On the other hand, mismanagement of NOT may have negative impact on OR efficiency and surgeon's, patient's, and staff's satisfaction.

In that regard, IT of general anesthesia can be strongly prolonged due to difficulties in obtaining venous access. ET from general anesthesia that starts after completion of the surgical procedure and the cessation of anesthetic delivery until extubation is largely under the control of the anesthetist. It can be influenced by anesthetic agent choice, dose, and dose duration and moreover the risk of prolonged ET is inversely related with the anesthesia resident training duration. TOT is defined as the time from when the patient's bed exited the OR to the time when the next patient's bed entered the OR and is mostly influenced by the efficiency of the housekeeping staff to clean the OR and the nursing team to prepare the OR for the next patient.

Bilateral third molar surgery is one of the most commonly performed short-duration procedures performed in an ambulatory setting. Dental surgery performed under general anesthesia is associated with minimized anxiety and high patient satisfaction levels. Therefore, general anesthesia is recommended in patients with severe anxiety or pronounced vomiting reflex and in patients undergoing bilateral third molar surgery.

To improve OR efficiency during bilateral third molar surgery under general anesthesia, the investigators have developed a comprehensive program including enhanced preoperative preparation of patients, the development of a procedure-specific anesthesia protocol and the formation of a dedicated operating room team. Enhanced preoperative preparation includes preoperatively performing intravenous cannulation and administration of intravenous antibiotics on the ambulatory ward. In the anesthesia protocol, only short or very short acting agents are selected and the dedicated operating room team consists of 2 very well-trained OR nurses and a highly experienced anesthesiologist who all have frequent exposure to surgical stomatology programs.

Being tested
Control preoperative program, Advanced preoperative program
Keywords
operation room efficiency, third molar surgery

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Control preoperative programProcedure or surgery

    Patients will undergo a control preoperative program with no enhances preparation when undergoing bilateral third molar extraction

  • Advanced preoperative programProcedure or surgery

    Patients will undergo an comprehensive program including enhanced preoperative preparation and a dedicated operating room team when undergoing bilateral third molar extraction

Study groups in NCT06873152
Study groupRoleWhat they receive
Control groupSham comparatorThe operation room team will consist of a randomly planned team which may also comprise nurse trainees and/or anesthesiology residents. At arrival in the operating theatre, all patients will be placed in the supine position and receive full standard monitoring (non-invasive blood pressure monitoring, electrocardiographic monitoring, and peripheral O2 saturation monitoring). Furthermore, they will receive an intravenous access with 0.9% sodium chloride infusion and will be administered clindamycine 900mg IV.
Receives: Procedure: Control preoperative program
Experimental groupExperimentalAll patients planned on an experimental stomatology program day will receive an intravenous access with 0.9% sodium chloride infusion at the ambulatory ward and will be administered clindamycine 900mg IV 30 minutes before the start of surgery. During an experimental stomatology program day, the OR team will consist of 2 very well-trained OR nurses who are exclusively dedicated to the maxillofacial surgery department and a highly experienced anesthesiologist who also has frequent exposure to surgical maxillofacial interventions programs. Nurse trainees and/or anesthesiology residents will not be planned in the stomatology OR on experimental days.
Receives: Procedure: Advanced preoperative program

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Evaluation of total operation room stay time

    Evaluation of the Total Operation room (OR) stay time defined as departure time from the OR minus arrival time in the OR

    Measured: on day of surgery, day 0

Secondary outcomes (9)
  1. Evaluation of the surgical time

    Evaluation of the Surgical time (ST) defined as the time from application of dressings and incision to surgical completion

    Measured: on day of surgery, day 0

  2. Evaluation of Anesthesia induction time

    Evaluation of Anesthesia induction time (IT) defined as time interval between arrival to the OR and patient handover to surgical team.

    Measured: on day of surgery, day 0

  3. Evaluation of emergence time

    Emergence time (ET) defined as the time interval between end of surgery and patient wheeled out of the OR

    Measured: on day of surgery, day 0

  4. evaluation of turnover time

    turnover time (TOT) defined as the time from when the patient's bed exited the OR to the time when the next patient's bed entered the OR

    Measured: on day of surgery, day 0

  5. Evaluation of non operative time

    • Nonoperative time (NOT) defined as the time between surgical completion of the previous case and skin incision on the following case.

    Measured: on day of surgery, day 0

  6. Evaluation of pain

    • Mean postoperative pain intensity at rest measured by an 11-point Numeric Rating Scale (NRS) (with 0 no pain and 10 extreme pain) at baseline, 4, 8 and 24 hours after surgery

    Measured: baseline, 4, 8 and 24hours after surgery

  7. Evaluation of hospital length of stay

    Evaluation of hospital length of stay in hours

    Measured: on day of surgery, day 0

  8. Evaluation of time to be fit for discharge

    • Time to be fit for hospital discharge after the end of surgery as defined by reaching all of the following criteria:
    • Oral pain medication only
    • Independent walking
    • No PONV
    • Bowel movement
    • Oral Intake
    • Hemodynamically (90% of baseline BP, HR in 90% of normal range) and respiratory stable (no need for extra oxygen)
    • No drains or urinary catheters

    Measured: on day of surgery, day 0

  9. Evaluation of patient satisfaction

    General patient satisfaction with perioperative anesthesia and analgesia: this will be evaluated by telephone call at postoperative day (POD) 1 by the study assistant with a 10-point Likert Scale with 1 being extremely dissatisfied and 10 being extremely satisfied

    Measured: one day after the surgery, day 1

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Mar 2025
  2. Study start10 Mar 2025
  3. Primary completion27 May 2025
  4. Study completion27 May 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
130 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06873152
Sponsor's protocol ID
2025/007
Acronym
PREPARE
Status last verified
Sep 2025
First submitted
5 Mar 2025
Last updated
29 Sep 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Advanced preoperative program in people with Third Molars Extraction, run by Jessa Hospital at 1 site in Belgium.

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 5 inclusion and 2 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 29 Sep 2025. 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 Belgium. 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. Some participants in this study may receive a placebo. 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?

Evaluation of total operation room stay time (time frame: on day of surgery, day 0). 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 29 Sep 2025.

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