Skip to main content
Clinical Trials/NCT01937247
NCT01937247
Completed
Phase 2

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

American University of Beirut Medical Center1 site in 1 country120 target enrollmentMay 18, 2018

Overview

Phase
Phase 2
Intervention
STANDARD PROCESS
Conditions
Non-operative Time
Sponsor
American University of Beirut Medical Center
Enrollment
120
Locations
1
Primary Endpoint
Non-operative time
Status
Completed
Last Updated
4 years ago

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.

Registry
clinicaltrials.gov
Start Date
May 18, 2018
End Date
October 30, 2020
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Roland Kaddoum

Assistant Professor, MD

American University of Beirut Medical Center

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.

Arms & Interventions

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

Intervention: STANDARD 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

Intervention: Patients will be inducted in the induction room

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

Intervention: 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

Intervention: patient will be reversed with sugammadex 4mg/kg IV

Outcomes

Primary Outcomes

Non-operative time

Time Frame: 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 Outcomes

  • Complication rate(wihtin 24 hours of srugery)
  • Patient satisfaction(within 24-48 hours aftery surgery)
  • Satisfaction of the operation room staff and surgeons with the redesigned process(within 24-48 hours after surgery)

Study Sites (1)

Loading locations...

Similar Trials