Non-operative TimePhase 2/3NCT01937247
Redesigned Process in the Operating Room
A Phase 2/3 study testing Patients will be inducted in the induction room, Redesigned process and patient will be reversed with sugammadex 4mg/kg IV in people with Non-operative Time and General Surgery, Above 18 Years of Age, run by American University of Beirut Medical Center at 1 site in Lebanon.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Non-operative Time, General Surgery, Above 18 Years of Age
- What is being tested?
- Patients will be inducted in the induction room, Redesigned process and patient will be reversed with sugammadex 4mg/kg IV
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteLebanon
- Study dates
- 18 May 2018to 30 Oct 2020
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Redesigned Process in the Operating Room: Monitoring and Evaluating Success of Reducing Non Operative Time
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.
Read the 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.
- Being tested
- Patients will be inducted in the induction room, Redesigned process, patient will be reversed with sugammadex 4mg/kg IV, STANDARD PROCESS
- Keywords
- Operative Time, Operating Rooms, Efficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patients will be inducted in the induction roomProcedure or surgery
The patients will be inducted in the induction room
Redesigned processProcedure or surgery
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 IVDrug
The patient will be reversed with sugammadex 4mg/kg IV, and then extubated before being moved out of the OR
STANDARD PROCESSProcedure or surgery
standard process
| Study group | Role | What they receive |
|---|---|---|
| Standard process | Placebo comparator | 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 Receives: Procedure: STANDARD PROCESS |
| Redesigned process | Active comparator | 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 Receives: Procedure: Patients will be inducted in the induction room; Procedure: Redesigned process; Drug: patient will be reversed with sugammadex 4mg/kg IV |
What is being measured
The primary outcome is the main question the study is designed to answer.
Non-operative time
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
Measured: within 24 hours of surgery
Secondary outcomes (3)
Satisfaction of the operation room staff and surgeons with the redesigned process
semi-structured individual interviews
Measured: within 24-48 hours after surgery
Patient satisfaction
Patient satisfaction survey
Measured: within 24-48 hours aftery surgery
Complication rate
Measured: wihtin 24 hours of srugery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2013 (estimated)
- Study start18 May 2018
- Primary completion30 Oct 2020
- Study completion30 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Non-operative TimeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- American University of Beirut Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Principal investigator, Roland Kaddoum, American University of Beirut Medical Center
- Investigators
- Roland Kaddoum, MD, Principal investigator, American University of Beirut Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01937247
- Sponsor's protocol ID
- ANES.RK.04
- Other IDs
- AUBMC
- Status last verified
- Feb 2022
- First submitted
- 29 Aug 2013
- Last updated
- 9 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kaddoum R, Tarraf S, Shebbo FM, Bou Ali A, Karam C, Abi Shadid C, Bouez J, Aouad MT. Reduction of Nonoperative Time Using the Induction Room, Parallel Processing, and Sugammadex: A Randomized Clinical Trial. Anesth Analg. 2022 Aug 1;135(2):406-413. doi: 10.1213/ANE.0000000000006102. Epub 2022 Jun 3.
PubMed 35839499
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Redesigned Process in the Operating Room: Monitoring and Evaluating Success of Reducing Non Operative Time
- ClinicalTrials.gov ID
- NCT01937247
- Acronym / sponsor ID
- ANES.RK.04
- Keywords
- Operative Time, Operating Rooms, Efficiency
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- American University of Beirut Medical CenterUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- 18 May 2018 (actual)
- Primary completion
- 30 Oct 2020 (actual)
- Study completion
- 30 Oct 2020 (actual)
- First posted
- 9 Sep 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard process | Placebo comparator | Procedure: STANDARD PROCESSThe 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 |
| Redesigned process | Active comparator | Procedure: Patients will be inducted in the induction room, Procedure: Redesigned process, Drug: patient will be reversed with sugammadex 4mg/kg IVPatients 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Patients will be inducted in the induction roomThe patients will be inducted in the induction room | Procedure or surgery | Redesigned process |
| Redesigned processThe registered nurse will call in the house keeper to start cleaning of the OR (parallel processing) before the patient exits the room | Procedure or surgery | Redesigned process |
| patient will be reversed with sugammadex 4mg/kg IVThe patient will be reversed with sugammadex 4mg/kg IV, and then extubated before being moved out of the OR | Drug | Redesigned process |
| STANDARD PROCESSstandard process | Procedure or surgery | Standard process |
Primary outcome
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
3 secondary outcomes
Satisfaction of the operation room staff and surgeons with the redesigned process
Time frame: within 24-48 hours after surgery
Patient satisfaction
Time frame: within 24-48 hours aftery surgery
Complication rate
Time frame: wihtin 24 hours of srugery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2022.
- Derived from this study: PubMed 35839499Kaddoum R, Tarraf S, Shebbo FM, Bou Ali A, Karam C, Abi Shadid C, Bouez J, Aouad MT. Reduction of Nonoperative Time Using the Induction Room, Parallel Processing, and Sugammadex: A Randomized Clinical Trial. Anesth Analg. 2022 Aug 1;135(2):406-413. doi: 10.1213/ANE.0000000000006102. Epub 2022 Jun 3.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Roland Kaddoum, MD principal investigator
American University of Beirut Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Patients will be inducted in the induction room, Redesigned process and patient will be reversed with sugammadex 4mg/kg IV in people with Non-operative Time and General Surgery, Above 18 Years of Age, run by American University of Beirut Medical Center at 1 site in Lebanon.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Lebanon. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Non-operative time (time frame: within 24 hours of surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01937247, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2022.