Clinical trial NCT01937247: Redesigned Process in the Operating Room
Official title: Redesigned Process in the Operating Room: Monitoring and Evaluating Success of Reducing Non Operative Time
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Non-operative Time
General Surgery, Above 18 Years of Age
Keywords: Operative Time
Operating Rooms
Efficiency
Lead sponsor: American University of Beirut Medical Center
Sponsor class: OTHER
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2013-09-09
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: Non-operative time
timeFrame: within 24 hours of surgery
Secondary outcomes:
measure: Satisfaction of the operation room staff and surgeons with the redesigned process
timeFrame: within 24-48 hours after surgery
measure: Patient satisfaction
timeFrame: within 24-48 hours aftery surgery
measure: Complication rate
timeFrame: wihtin 24 hours of srugery
Other outcomes:
Locations:
city: Beirut
country: Lebanon
facility: American University of Beirut Medical Center
Study officials:
affiliation: American University of Beirut Medical Center
name: Roland Kaddoum, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kaddoum R, Tarraf S, Shebbo FM, Bou Ali A, Karam C, Abi Shadid C, Bouez J, Aouad MT. Reduction of Nonoperative Time Using the Induction Room, Parallel Processing, and Sugammadex: A Randomized Clinical Trial. Anesth Analg. 2022 Aug 1;135(2):406-413. doi: 10.1213/ANE.0000000000006102. Epub 2022 Jun 3.