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Redesigned Process in the Operating Room

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

Status
Completed
Phases
Phase 2Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01937247
Enrollment
120
Registered
2013-09-09
Start date
2018-05-18
Completion date
2020-10-30
Last updated
2022-03-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Operative Time, Operating Rooms, Efficiency

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.

Interventions

PROCEDUREPatients will be inducted in the induction room

The patients will be inducted in the induction room

PROCEDURERedesigned process

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

DRUGpatient 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

PROCEDURESTANDARD PROCESS

standard process

Sponsors

Merck Sharp & Dohme LLC
CollaboratorINDUSTRY
American University of Beirut Medical Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Non-operative timewithin 24 hours of surgeryFor 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

MeasureTime frameDescription
Satisfaction of the operation room staff and surgeons with the redesigned processwithin 24-48 hours after surgerysemi-structured individual interviews
Patient satisfactionwithin 24-48 hours aftery surgeryPatient satisfaction survey
Complication ratewihtin 24 hours of srugery

Countries

Lebanon

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026