Redesigned Process in the Operating Room

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

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.

Study Overview

• Status: Completed
• Conditions: Non-operative Time; General Surgery, Above 18 Years of Age
• Intervention / Treatment: Procedure: STANDARD PROCESS; Procedure: Patients will be inducted in the induction room; Procedure: Redesigned process; Drug: patient will be reversed with sugammadex 4mg/kg IV

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.

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Lebanon
  • Beirut, Lebanon
    • American University of Beirut Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Standard process; 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; standard process
Active Comparator: Redesigned 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	Procedure: Patients will be inducted in the induction room; The patients will be inducted in the induction room; Procedure: Redesigned process; The registered nurse will call in the house keeper to start cleaning of the OR (parallel processing) before the patient exits the room; Drug: patient will be reversed with sugammadex 4mg/kg IV; The patient will be reversed with sugammadex 4mg/kg IV, and then extubated before being moved out of the OR

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

Collaborators and Investigators

• Sponsor: American University of Beirut Medical Center
• Collaborators: Merck Sharp & Dohme LLC
• Investigators: Principal Investigator: Roland Kaddoum, MD, American University of Beirut Medical Center

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 18, 2018
• Primary Completion (Actual): October 30, 2020
• Study Completion (Actual): October 30, 2020

Study Registration Dates

• First Submitted: August 29, 2013
• First Submitted That Met QC Criteria: September 4, 2013
• First Posted (Estimate): September 9, 2013

Study Record Updates

• Last Update Posted (Actual): March 9, 2022
• Last Update Submitted That Met QC Criteria: February 23, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Keywords: Efficiency; Operative Time; Operating Rooms
• Other Study ID Numbers: ANES.RK.04; AUBMC (Other Identifier: AUBMC)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No