Redesigned Process in the Operating Room

Study Overview
=================
Brief Summary
-----------------
The main purpose of the study is to examine whether operating room (OR) efficiency will be improved by significantly decreasing non operative time. This study also aims: 1) to evaluate whether a decrease in non-operative time will result in increased surgeon and staff satisfaction, 2) to determine whether there is an increase in the complication rate during the redesigned process perioperatively and until discharge from the post anesthesia care unit, and 3) to rate patient satisfaction.

Detailed Description
-----------------
The study aims to examine whether operating room efficiency will be improved by decreasing non operative time while ensuring patient safety. Patients will be randomized into one of two groups: In group A (new process): patients will be inducted in the induction room. At the end of surgery and after placement of the surgical dressing, the registered nurse will call in the house keeper to start cleaning of the OR (parallel processing) before the patient exits the room. The patient will be reversed with sugammadex 4mg/kg IV, and then extubated before being moved out of the OR. In group B (the current practice at AUBMC), patients will be treated as follows: patients will be induced in the operating room and at the end of surgery will be reversed with neostigmine 50µg/kg and glycopyrrolate 10µg/kg. Once extubated and rolled out of the room, the house keeper team will start cleaning the operating room. Induction time (IT), emergence time (ET), and turn over time (TOT) will be recorded for both groups. We expect to show that OR efficiency will be improved by significantly decreasing non operative time while ensuring patient safety.

Official Title
-----------------
Redesigned Process in the Operating Room: Monitoring and Evaluating Success of Reducing Non Operative Time

Conditions
-----------------
Non-operative Time, General Surgery, Above 18 Years of Age

Intervention / Treatment
-----------------
* Procedure: Patients will be inducted in the induction room
* Procedure: Redesigned process
* Drug: patient will be reversed with sugammadex 4mg/kg IV
* Procedure: STANDARD PROCESS


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients, above 18 years of age, undergoing general surgery for surgeon X under general anesthesia Patients undergoing only the following general surgeries: laparoscopic hernia, laparoscopic appendectomy, laparoscopic cholecystectomy, and laparoscopic gastric/band sleeve surgeries American Society of Anesthesiologist Physical Status (ASA) I or II Research participant willing to sign informed written consent. Exclusion Criteria: Patients under 18 years of age Patients undergoing general surgery for surgeon X under regional or spinal anesthesia Patients undergoing surgeries other than the following: laparoscopic hernia, laparoscopic appendectomy, laparoscopic cholecystectomy, and laparoscopic gastric/band sleeve surgeries American Society of Anesthesiologist Physical Status (ASA) III, IV, V, and VI Emergency and lifesaving Cases Inability or unwillingness of research participant or legal guardian/representative to give written informed consent. Inability to bring the next patient to the induction room for uncontrollable reasons such as failure of equipment, late arrival to the hospital, or late financial or medical clearance.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Standard process<br>The control group is placebo group and this is our standard practice. Patients will be induced in the operating room and at the end of surgery will be reversed with neostigmine 50µg/kg and glycopyrrolate 10µg/kg. Once extubated and rolled out of the room, the house keeper team will start cleaning the operating room | Procedure: STANDARD PROCESS<br>* standard process<br>|
| Active Comparator: Redesigned process<br>Patients will be inducted in the induction room. At the end of surgery and after placement of the surgical dressing, the registered nurse will call in the house keeper to start cleaning of the OR (parallel processing) before the patient exits the room. The patient will be reversed with sugammadex 4mg/kg IV | Procedure: Patients will be inducted in the induction room<br>* The patients will be inducted in the induction room<br>Procedure: Redesigned process<br>* The registered nurse will call in the house keeper to start cleaning of the OR (parallel processing) before the patient exits the room<br>Drug: patient will be reversed with sugammadex 4mg/kg IV<br>* The patient will be reversed with sugammadex 4mg/kg IV, and then extubated before being moved out of the OR<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Non-operative time | For Group A, non-operative time is defined as induction, emergence and turnover time For Group B, non-operative time is defined as turnover time | within 24 hours of surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Satisfaction of the operation room staff and surgeons with the redesigned process | semi-structured individual interviews | within 24-48 hours after surgery | 
| Patient satisfaction | Patient satisfaction survey | within 24-48 hours aftery surgery | 
| Complication rate |  | wihtin 24 hours of srugery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Operative Time, Operating Rooms, Efficiency