Redesigned Process in the Operating Room

General Surgery, Above 18 Years of Age Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01937247
• Other study ID #: ANES.RK.04
• Secondary ID: AUBMC
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: May 18, 2018
• Est. completion date: October 30, 2020

Study information

• Verified date: February 2022
• Source: American University of Beirut Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: October 30, 2020
• Est. primary completion date: October 30, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

Procedure:
• Patients will be inducted in the induction room
The patients will be inducted in the induction room
• 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

Procedure:
• STANDARD PROCESS
standard process

Locations

Country	Name	City	State
Lebanon	American University of Beirut Medical Center	Beirut

Sponsors (2)

Lead Sponsor	Collaborator
American University of Beirut Medical Center	Merck Sharp & Dohme Corp.

Country where clinical trial is conducted

Lebanon, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Satisfaction of the operation room staff and surgeons with the redesigned process	semi-structured individual interviews	within 24-48 hours after surgery
Secondary	Patient satisfaction	Patient satisfaction survey	within 24-48 hours aftery surgery
Secondary	Complication rate		wihtin 24 hours of srugery