Obstructive Sleep ApneaPhase 4SugammadexNCT03679611
Impact of Sugammadex vs. Neostigmine Reversal on Post-Operative Recovery and Complications
A Phase 4 study testing Sugammadex Sodium and Neostigmine in people with Obstructive Sleep Apnea, run by University Health Network, Toronto at 1 site in Canada.
Trial summary
Sugammadex or neostigmine are given at the end of the surgery to reverse neuro muscular blocking drugs (NMBD). This study will evaluate whether reversal of NMBD with sugammadex is associated with faster recovery than neostigmine resulting in faster discharge from the operating room (OR) in obese patients with OSA… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Obstructive Sleep Apnea
- What is being tested?
- Sugammadex Sodium and Neostigmine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteCanada
- Study dates
- 14 Jan 2019to 26 Oct 2021
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years old
- Diagnosed Obstructive Sleep Apnea patients by polysomnography
- Scheduled elective bariatric surgery
Who cannot join
- Age<18 years old
- Allergy to rocuronium
- Allergy to sugammadex
- Allergy to neostigmine
- Malignant hyperthermia
- Hepatic insufficiency
Show all 9Show fewer
- Renal insufficiency
- Neuromuscular Disease
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Sugammadex vs. Neostigmine Reversal on Post-Operative Recovery And Postoperative Complications In Patients With Obstructive Sleep Apnea Undergoing Bariatric Surgery: A Double-Blind, Randomized Controlled Trial
Sugammadex or neostigmine are given at the end of the surgery to reverse neuro muscular blocking drugs (NMBD). This study will evaluate whether reversal of NMBD with sugammadex is associated with faster recovery than neostigmine resulting in faster discharge from the operating room (OR) in obese patients with OSA undergoing bariatric surgery. Half of the patients in the study will receive sugammadex and the other half of the patients will receive neostigmine.
Read the detailed description
Sugammadex and neostigmine are NMBD reversal agents. Neostigmine - an anticholinesterase is given to reverse NMBD; however reversal of NMBD with neostigmine may be associated with residual neuromuscular blockade in up to 64% patients postoperatively in the post anesthesia care unit. Even mild degrees of residual neuromuscular blockade can have serious clinical consequences in the postoperative period. The severity of OSA often worsens after surgery and patients with OSA are at increased risk for early respiratory complications after extubating and in the PACU. Morbid obesity is associated with critical respiratory complications in patients with OSA.
Sugammadex is a newer NMBD reversal agent that rapidly and completely reverses rocuronium. It is a modified gamma cyclodextrin that forms a complex with the neuromuscular blocking agent rocuronium. It reduces the amount of neuromuscular blocking agent available to bind to nicotinic cholinergic receptors in the neuromuscular junction. It has been shown to more rapidly reverse residual neuromuscular blockade than neostigmine in obese patients without obstructive sleep apnea (OSA).
This study will evaluate whether reversal of NMBD with sugammadex is associated with faster recovery than neostigmine resulting in faster discharge from the operating room (OR) in obese patients with OSA undergoing bariatric surgery. Half of the patients in the study will receive sugammadex and other half of the patients will receive neostigmine
- Conditions
- Obstructive Sleep Apnea
- Being tested
- Sugammadex Sodium, Neostigmine
- Keywords
- Recovery time, reversal of neuromuscular blockers (NMB), obstructive sleep apnea, morbid obesity, bariatric surgery
- Medical subject headings
- Sleep Apnea, Obstructive, Obesity, Morbid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sugammadex SodiumDrug
Also called Bridion
Sugammadex is a FDA approved newer NMBD reversal agent. But does not use in standard of care in most of institutions This study is designed to compare the impact of reversal of neuromuscular blockade with sugammadex vs. neostigmine on discharge time from the operating room in obese patients with OSA undergoing bariatric surgery
NeostigmineDrug
Also called prostigmin
neostigmine is a FDA approved NMBD reversal drug, uses as standard care drug in most of the institutions. neostigmine use as active comparator to compare with investigational drug Sugammadex in the study.
| Study group | Role | What they receive |
|---|---|---|
| Interventional Arm | Experimental | Interventional Arm will receive sugammadex sodium 2 mg/kg actual body weight, At the end of surgery Sugammadex will be administered when the TOF reveals at least 2 responses Receives: Drug: Sugammadex Sodium |
| Standard drug Arm | Active comparator | standard drug Arm will receive neostigmine 2.5 mg and glycopyrrolate 0.4 mg, At the end of surgery neostigmine and glycopyrrolate will be administered when the TOF reveals at least 2 responses Receives: Drug: Neostigmine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Discharge From Operating Room
The time from study drug administration to discharge from operating room (OR).
Measured: 15 minutes
Secondary outcomes (1)
Time the Patient Open Eyes to Command
Time from study drug administration to the patient open eyes to command.
Measured: 15 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2018
- Study start14 Jan 2019
- Primary completion26 Oct 2021
- Study completion26 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Obstructive Sleep ApneaStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe 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
- Model description
- This study is a prospective, double-blinded randomized controlled superiority trial with two parallel groups. Randomization will be performed with a 1:1 allocation into reversal of neuromuscular blocking drugs (NMBD) with sugammadex or neostigmine.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Canada Inc.
- Responsible party
- Principal investigator, Jean Wong, University Health Network, Toronto
- Investigators
- Jean Wong, MD, Principal investigator, University Health Network, Toronto Western Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03679611
- Sponsor's protocol ID
- 18-5629
- Acronym
- Sugammadex
- Status last verified
- Mar 2025
- First submitted
- 13 Sep 2018
- Last updated
- 20 Mar 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Research study results will be presented for publication in peer reviewed journals by the protocol.
Publications
Ajetunmobi O, Wong D, Perlas A, Rajaleelan W, Wang S, Huszti E, Jackson T, Chung F, Wong J. Impact of Sugammadex Versus Neostigmine Reversal on Postoperative Recovery Time in Patients With Obstructive Sleep Apnea Undergoing Bariatric Surgery: A Double-Blind, Randomized Controlled Trial. Anesth Analg. 2025 Mar 1;140(3):568-576. doi: 10.1213/ANE.0000000000007013. Epub 2024 Jun 7.
PubMed 38848257
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Sugammadex vs. Neostigmine Reversal on Post-Operative Recovery And Postoperative Complications In Patients With Obstructive Sleep Apnea Undergoing Bariatric Surgery: A Double-Blind, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03679611
- Acronym / sponsor ID
- Sugammadex / 18-5629
- Conditions
- Obstructive Sleep Apnea
- Keywords
- Recovery time, reversal of neuromuscular blockers (NMB), obstructive sleep apnea, morbid obesity, bariatric surgery
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Collaborators
- Merck Canada Inc.
- Study start
- 14 Jan 2019 (actual)
- Primary completion
- 26 Oct 2021 (actual)
- Study completion
- 26 Oct 2021 (actual)
- First posted
- 20 Sep 2018 (actual)
- Results
- Posted 20 Mar 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Sugammadex or neostigmine are given at the end of the surgery to reverse neuro muscular blocking drugs (NMBD). This study will evaluate whether reversal of NMBD with sugammadex is associated with faster recovery than neostigmine resulting in faster discharge from the operating room (OR) in obese patients with OSA undergoing bariatric surgery. Half of the patients in the study will receive sugammadex and the other half of the patients will receive neostigmine.
Detailed description
Sugammadex and neostigmine are NMBD reversal agents. Neostigmine - an anticholinesterase is given to reverse NMBD; however reversal of NMBD with neostigmine may be associated with residual neuromuscular blockade in up to 64% patients postoperatively in the post anesthesia care unit. Even mild degrees of residual neuromuscular blockade can have serious clinical consequences in the postoperative period. The severity of OSA often worsens after surgery and patients with OSA are at increased risk for early respiratory complications after extubating and in the PACU. Morbid obesity is associated with critical respiratory complications in patients with OSA.
Sugammadex is a newer NMBD reversal agent that rapidly and completely reverses rocuronium. It is a modified gamma cyclodextrin that forms a complex with the neuromuscular blocking agent rocuronium. It reduces the amount of neuromuscular blocking agent available to bind to nicotinic cholinergic receptors in the neuromuscular junction. It has been shown to more rapidly reverse residual neuromuscular blockade than neostigmine in obese patients without obstructive sleep apnea (OSA).
This study will evaluate whether reversal of NMBD with sugammadex is associated with faster recovery than neostigmine resulting in faster discharge from the operating room (OR) in obese patients with OSA undergoing bariatric surgery. Half of the patients in the study will receive sugammadex and other half of the patients will receive neostigmine
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This study is a prospective, double-blinded randomized controlled superiority trial with two parallel groups. Randomization will be performed with a 1:1 allocation into reversal of neuromuscular blocking drugs (NMBD) with sugammadex or neostigmine.
| Arm | Type | Receives |
|---|---|---|
| Interventional Arm | Experimental | Drug: Sugammadex SodiumInterventional Arm will receive sugammadex sodium 2 mg/kg actual body weight, At the end of surgery Sugammadex will be administered when the TOF reveals at least 2 responses |
| Standard drug Arm | Active comparator | Drug: Neostigminestandard drug Arm will receive neostigmine 2.5 mg and glycopyrrolate 0.4 mg, At the end of surgery neostigmine and glycopyrrolate will be administered when the TOF reveals at least 2 responses |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age ≥ 18 years old
- Diagnosed Obstructive Sleep Apnea patients by polysomnography
- Scheduled elective bariatric surgery
Key exclusion criteria (9 listed)
- Age<18 years old
- Allergy to rocuronium
- Allergy to sugammadex
- Allergy to neostigmine
- Malignant hyperthermia
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 SodiumAlso: BridionSugammadex is a FDA approved newer NMBD reversal agent. But does not use in standard of care in most of institutions This study is designed to compare the impact of reversal of neuromuscular blockade with sugammadex vs. neostigmine on discharge time from the operating room in obese patients with OSA undergoing bariatric surgery | Drug | Interventional Arm |
| NeostigmineAlso: prostigminneostigmine is a FDA approved NMBD reversal drug, uses as standard care drug in most of the institutions. neostigmine use as active comparator to compare with investigational drug Sugammadex in the study. | Drug | Standard drug Arm |
Primary outcome
Time to Discharge From Operating Room
Time frame: 15 minutes
The time from study drug administration to discharge from operating room (OR).
1 secondary outcome
Time the Patient Open Eyes to Command
Time frame: 15 minutes
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38848257Ajetunmobi O, Wong D, Perlas A, Rajaleelan W, Wang S, Huszti E, Jackson T, Chung F, Wong J. Impact of Sugammadex Versus Neostigmine Reversal on Postoperative Recovery Time in Patients With Obstructive Sleep Apnea Undergoing Bariatric Surgery: A Double-Blind, Randomized Controlled Trial. Anesth Analg. 2025 Mar 1;140(3):568-576. doi: 10.1213/ANE.0000000000007013. Epub 2024 Jun 7.
- Individual participant dataSharing planned: No. Research study results will be presented for publication in peer reviewed journals by the protocol.
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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.
Jean Wong, MD principal investigator
University Health Network, Toronto Western Hospital
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 Sodium and Neostigmine in people with Obstructive Sleep Apnea, run by University Health Network, Toronto at 1 site in Canada.
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 3 inclusion and 9 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 20 Mar 2025. 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 Canada. 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?
Yes. Results are posted in the registry (first posted 20 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Time to Discharge From Operating Room (time frame: 15 minutes). 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 NCT03679611, 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 20 Mar 2025.