Redesigned Process in the Operating Room

Phase 2

Completed

• Conditions: Non-operative Time; General Surgery, Above 18 Years of Age
• Interventions: 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

• Registration Number: NCT01937247
• Lead Sponsor: American University of Beirut Medical Center

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.

Study Timeline

• Study First Submitted: 2013-08-29
• Study First Submitted QC: 2013-09-04
• Study First Posted: 2013-09-09
• Study Start: 2018-05-18
• Primary Completion: 2020-10-30
• Study Completion: 2020-10-30
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-23
• Last Update Posted: 2022-03-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard process	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
Redesigned process	patient will be reversed with sugammadex 4mg/kg IV	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
Redesigned process	Patients will be inducted in the induction room	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
Redesigned process	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

Primary Outcome Measures

Name	Time	Method
Non-operative time	within 24 hours of surgery	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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

American University of Beirut Medical Center; 🇱🇧 Beirut, Lebanon