Improvement of Operating Room Efficiency in Bilateral Wisdom Teeth Surgery (PREPARE)

September 26, 2025 updated by: Stessel Björn, Jessa Hospital

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".

Study Overview

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.

Study Type

Interventional

Enrollment (Actual)

130

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Limburg
      • Hasselt, Limburg, Belgium, 3500
        • Jessa Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Sham Comparator: Control group

The 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.

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

All 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.

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of total operation room stay time
Time Frame: on day of surgery, day 0
Evaluation of the Total Operation room (OR) stay time defined as departure time from the OR minus arrival time in the OR
on day of surgery, day 0

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of the surgical time
Time Frame: on day of surgery, day 0
Evaluation of the Surgical time (ST) defined as the time from application of dressings and incision to surgical completion
on day of surgery, day 0
Evaluation of Anesthesia induction time
Time Frame: on day of surgery, day 0
Evaluation of Anesthesia induction time (IT) defined as time interval between arrival to the OR and patient handover to surgical team.
on day of surgery, day 0
Evaluation of emergence time
Time Frame: on day of surgery, day 0
Emergence time (ET) defined as the time interval between end of surgery and patient wheeled out of the OR
on day of surgery, day 0
evaluation of turnover time
Time Frame: on day of surgery, day 0
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
on day of surgery, day 0
Evaluation of non operative time
Time Frame: on day of surgery, day 0
- Nonoperative time (NOT) defined as the time between surgical completion of the previous case and skin incision on the following case.
on day of surgery, day 0
Evaluation of pain
Time Frame: baseline, 4, 8 and 24hours after surgery
- 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
baseline, 4, 8 and 24hours after surgery
Evaluation of hospital length of stay
Time Frame: on day of surgery, day 0
Evaluation of hospital length of stay in hours
on day of surgery, day 0
Evaluation of time to be fit for discharge
Time Frame: on day of surgery, day 0

- 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
on day of surgery, day 0
Evaluation of patient satisfaction
Time Frame: one day after the surgery, day 1
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
one day after the surgery, day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 10, 2025

Primary Completion (Actual)

May 27, 2025

Study Completion (Actual)

May 27, 2025

Study Registration Dates

First Submitted

March 5, 2025

First Submitted That Met QC Criteria

March 6, 2025

First Posted (Actual)

March 12, 2025

Study Record Updates

Last Update Posted (Estimated)

September 29, 2025

Last Update Submitted That Met QC Criteria

September 26, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • 2025/007

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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