Clinical trial NCT06873152: Improvement of Operating Room Efficiency in Bilateral Wisdom Teeth Surgery
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)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Third Molars Extraction
Keywords: operation room efficiency
third molar surgery
Lead sponsor: Jessa Hospital
Sponsor class: OTHER
First posted: 2025-03-12
Enrollment: 130
Sex: ALL
Minimum age (years): 16
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief 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. The investigators hypothesize that this comprehensive program will be superior in terms of OR efficiency compared to "business as usual".

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.

Eligibility criteria: 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

Primary outcomes:
measure: Evaluation of total operation room stay time
timeFrame: on day of surgery, day 0
Secondary outcomes:
measure: Evaluation of the surgical time
timeFrame: on day of surgery, day 0
measure: Evaluation of Anesthesia induction time
timeFrame: on day of surgery, day 0
measure: Evaluation of emergence time
timeFrame: on day of surgery, day 0
measure: evaluation of turnover time
timeFrame: on day of surgery, day 0
measure: Evaluation of non operative time
timeFrame: on day of surgery, day 0
measure: Evaluation of pain
timeFrame: baseline, 4, 8 and 24hours after surgery
measure: Evaluation of hospital length of stay
timeFrame: on day of surgery, day 0
measure: Evaluation of time to be fit for discharge
timeFrame: on day of surgery, day 0
measure: Evaluation of patient satisfaction
timeFrame: one day after the surgery, day 1
Other outcomes:
Locations:
city: Hasselt
country: Belgium
facility: Jessa Hospital
state: Limburg
Study officials:
References: