Redesigned Process in the Operating Room

American University of Beirut Medical Center

Status and phase: Completed; Phase 3; Phase 2

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

Treatments: Procedure: STANDARD PROCESS; Procedure: Patients will be inducted in the induction room; Drug: patient will be reversed with sugammadex 4mg/kg IV; Procedure: Redesigned process

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01937247

AUBMC (Other Identifier)

ANES.RK.04

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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120 participants in 2 patient groups, including a placebo group

Standard process

Placebo Comparator group

Description:

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

Treatment:

Procedure: STANDARD PROCESS

Redesigned process

Active Comparator group

Description:

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

Treatment:

Procedure: Patients will be inducted in the induction room

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

Procedure: Redesigned process