Redesigned Process in the Operating Room

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-05-18

Study Completion Date

2020-10-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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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

Group Type PLACEBO_COMPARATOR

STANDARD PROCESS

Intervention Type PROCEDURE

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

Group Type ACTIVE_COMPARATOR

Patients will be inducted in the induction room

Intervention Type PROCEDURE

The patients will be inducted in the induction room

Redesigned process

Intervention Type 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

Intervention Type DRUG

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

Interventions

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Patients will be inducted in the induction room

The patients will be inducted in the induction room

Intervention Type PROCEDURE

Redesigned process

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

Intervention Type PROCEDURE

patient 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

Intervention Type DRUG

STANDARD PROCESS

standard process

Intervention Type PROCEDURE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes