Neuromuscular BlockadePhase 4NCT01761552
A Prospective, Randomized Controlled Trial Comparing Traditional Methods of Neuromuscular Block Reversal to Sugammadex for Extubation in the Operating Room in ASA 4 and 4E Patients
A Phase 4 study testing Sugammadex Reversal and Atropine/Neostigmine in people with Neuromuscular Blockade, run by Hadassah Medical Organization at 1 site in Israel.
Trial summary
To demonstrate that the use of Sugammadex enables physicians to perform early extubation in the operating room in ASA 4 \& 4E patients Primary endpoint: Extubation in the operating room before transfer to the PACU or ICU versus keeping the patient intubated when transferred. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neuromuscular Blockade
- What is being tested?
- Sugammadex Reversal and Atropine/Neostigmine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 siteIsrael
- Study dates
- Aug 2013to Dec 2015
- Phase
- Phase 4
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA 4 AND ASA 4E patients
- Patients scheduled to undergo any bowel, urogenital or orthopedic surgery under general anesthesia where use of neuromuscular blocking agents is indicated. -
Who cannot join
- Patients ASA 1-3 or 5
- Patients who have a medical condition which precludes extubation at the end of surgery (i.e., mesenteric event, severe hypothermia etc.).
- Presence of an advanced directive to withhold or withdraw life sustaining treatment (i.e. DNR).
- Hypersensitivity to the active substances or to any of the excipients of medications used
- Patients with severe renal impairment (including patients requiring dialysis (CrCl < 30mL/min))
- Patients with severe hepatic impairment
- Age < 18 years
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Hadassah Medical Organization
Jerusalem, 91120
Yoram Weiss, MD
About this study
Official title: A Prospective, Randomized Controlled Trial Comparing Traditional Methods of Neuromuscular Block Reversal to Sugammadex for Extubation in the Operating Room in ASA 4 and 4E Patients.
To demonstrate that the use of Sugammadex enables physicians to perform early extubation in the operating room in ASA 4 \& 4E patients
Primary endpoint:
- Extubation in the operating room before transfer to the PACU or ICU versus keeping the patient intubated when transferred.
Secondary endpoints:
- Time to extubation - measure the difference in time from application of the surgical dressing until extubation. Atelectasis - comparison of chest x-rays (CXR): prior to surgery, on admission to PACU or ICU and 24 hours after admission to PACU or ICU (This is the routine practice at Hadassa hospital for ASA IV patients.)
- Conditions
- Neuromuscular Blockade
- Being tested
- Sugammadex Reversal, Atropine/Neostigmine
- Keywords
- in ASA 4 AND ASA 4E patients
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sugammadex ReversalDrug
Atropine/NeostigmineDrug
| Study group | Role | What they receive |
|---|---|---|
| Sugammadex (tradename Bridion) | Experimental | Not described Receives: Drug: Sugammadex Reversal |
| Traditional reversal or spontaneous recovery: | Active comparator | Atropine/Neostigmine: Atropine, 0.02 mg/ kg, and Neostigmine,0.05 mg/kg diluted in 100 ml Normal Saline and given over a 10 min drip. Reversal will be given only recommended if spontaneous recovery has occurred up to the reappearance of T2 (shallow blockade) following rocuronium induced blockade. Receives: Drug: Atropine/Neostigmine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Extubation in the operating room before transfer to the PACU or ICU versus keeping the patient intubated when transferred.
Measured: 24 hours
Secondary outcomes (2)
Time to extubation - measure the difference in time from application of the surgical dressing until extubation.
Measured: 24 hours
Atelectasis - comparison of chest x-rays (CXR): prior to surgery, on admission to PACU or ICU and 24 hours after admission to PACU or ICU (This is the routine practice at Hadassa hospital for ASA IV patients.)
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2013 (estimated)
- Study startAug 2013
- Primary completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuromuscular BlockadeStudies of the same condition, open and under way.
- More trials run by Hadassah Medical OrganizationThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hadassah Medical Organization
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yoram G Weiss, MD, Principal investigator, Hadassah Medical Organization
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01761552
- Sponsor's protocol ID
- 0513-12-HMO
- Status last verified
- Sep 2012
- First submitted
- 20 Dec 2012
- Last updated
- 10 Sep 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized Controlled Trial Comparing Traditional Methods of Neuromuscular Block Reversal to Sugammadex for Extubation in the Operating Room in ASA 4 and 4E Patients.
- ClinicalTrials.gov ID
- NCT01761552
- Acronym / sponsor ID
- 0513-12-HMO
- Conditions
- Neuromuscular Blockade
- Keywords
- in ASA 4 AND ASA 4E patients
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- Hadassah Medical OrganizationUniversity, hospital or other
- Study start
- Aug 2013
- Primary completion
- Dec 2015 (estimated)
- First posted
- 4 Jan 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.
To demonstrate that the use of Sugammadex enables physicians to perform early extubation in the operating room in ASA 4 \& 4E patients
Primary endpoint:
- Extubation in the operating room before transfer to the PACU or ICU versus keeping the patient intubated when transferred.
Secondary endpoints:
- Time to extubation - measure the difference in time from application of the surgical dressing until extubation. Atelectasis - comparison of chest x-rays (CXR): prior to surgery, on admission to PACU or ICU and 24 hours after admission to PACU or ICU (This is the routine practice at Hadassa hospital for ASA IV patients.)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sugammadex (tradename Bridion) | Experimental | Drug: Sugammadex Reversal |
| Traditional reversal or spontaneous recovery: | Active comparator | Drug: Atropine/NeostigmineAtropine/Neostigmine: Atropine, 0.02 mg/ kg, and Neostigmine,0.05 mg/kg diluted in 100 ml Normal Saline and given over a 10 min drip. Reversal will be given only recommended if spontaneous recovery has occurred up to the reappearance of T2 (shallow blockade) following rocuronium induced blockade. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- ASA 4 AND ASA 4E patients
- Patients scheduled to undergo any bowel, urogenital or orthopedic surgery under general anesthesia where use of neuromuscular blocking agents is indicated. -
Key exclusion criteria (7 listed)
- Patients ASA 1-3 or 5
- Patients who have a medical condition which precludes extubation at the end of surgery (i.e., mesenteric event, severe hypothermia etc.).
- Presence of an advanced directive to withhold or withdraw life sustaining treatment (i.e. DNR).
- Hypersensitivity to the active substances or to any of the excipients of medications used
- Patients with severe renal impairment (including patients requiring dialysis (CrCl < 30mL/min))
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 |
|---|---|---|
| Sugammadex Reversal | Drug | Sugammadex (tradename Bridion) |
| Atropine/Neostigmine | Drug | Traditional reversal or spontaneous recovery: |
Primary outcome
Extubation in the operating room before transfer to the PACU or ICU versus keeping the patient intubated when transferred.
Time frame: 24 hours
2 secondary outcomes
Time to extubation - measure the difference in time from application of the surgical dressing until extubation.
Time frame: 24 hours
Atelectasis - comparison of chest x-rays (CXR): prior to surgery, on admission to PACU or ICU and 24 hours after admission to PACU or ICU (This is the routine practice at Hadassa hospital for ASA IV patients.)
Time frame: 24 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2013.
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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.
Yoram G Weiss, MD principal investigator
Hadassah Medical Organization
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Sugammadex Reversal and Atropine/Neostigmine in people with Neuromuscular Blockade, run by Hadassah Medical Organization at 1 site in Israel.
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 2 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: status not confirmed, as of the sponsor's last update on 10 Sep 2013. 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 Israel. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hadas Lemberg, PhD (00 972 2 6777572, lhadas@hadassah.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Extubation in the operating room before transfer to the PACU or ICU versus keeping the patient intubated when transferred. (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Sep 2013.