Skip to main content
OpenTrials
Completed

NCT Number: NCT01937247

Redesigned Process in the Operating Room

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

American University of Beirut Medical Center

Beirut, Lebanon

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Patients will be inducted in the induction room

Procedure

The patients will be inducted in the induction room

Redesigned process

Procedure

The registered nurse will call in the house keeper to start cleaning of the OR (parallel processing) before the patient exits the room

patient will be reversed with sugammadex 4mg/kg IV

Drug

The patient will be reversed with sugammadex 4mg/kg IV, and then extubated before being moved out of the OR

STANDARD PROCESS

Procedure

standard process

Primary outcomes

  1. 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

  1. Satisfaction of the operation room staff and surgeons with the redesigned process

    Time frame: within 24-48 hours after surgery

    semi-structured individual interviews

  2. Patient satisfaction

    Time frame: within 24-48 hours aftery surgery

    Patient satisfaction survey

  3. Complication rate

    Time frame: wihtin 24 hours of srugery

Sponsors and collaborators

Lead sponsor

American University of Beirut Medical Center

Other

Collaborators

  • Merck Sharp & Dohme LLC

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Sep 9, 2013
Registry last updated
Mar 9, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.