Neuromuscular BlockadePhase 4NCT05661409
Sugammadex as Rescue Therapy
A Phase 4 study testing Sugammadex in people with Neuromuscular Blockade, run by Emory University at 1 site in United States.
Trial summary
Neuromuscular blocking agents (NMBAs) are commonly used in the practice of anesthesiology for skeletal muscle relaxation to facilitate tracheal intubation, mechanical ventilation, and to provide optimal surgical conditions. 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
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 46 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Jul 2023to 2 Aug 2024
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 18 years and above who will undergo an elective surgery in the main operating room or outpatient surgery center at Grady Memorial Hospital
- Receive general anesthesia (standardized to sevoflurane for maintenance)
- Receive rocuronium for NMB
- Receive neostigmine for NMB reversal
- Achieve a TOF count of at least 3 twitches but not a TOF ratio of 0.9 fifteen minutes after neostigmine has been given
- Able and willing to provide informed consent.
Who cannot join
- Pregnancy and/or lactating
- BMI ≥ 40
- Severe renal impairment, i.e. chronic kidney disease stages IV and V as defined by GFR < 30 ml/min/1.73 m2
- Severe hepatic impairment, i.e. Child-Pugh score C
- Pre-existing neuromuscular disease
- Anticipated need for postoperative intubation, and/or known hypersensitivity reactions to rocuronium, neostigmine and/or sugammadex.
Show all 10Show fewer
- Adults unable to consent
- Prisoners
- Cognitively impaired or Individuals with Impaired Decision-Making Capacity
- Individuals who are not able to clearly understand English
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Use of Sugammadex as Rescue Therapy Following Inadequate Reversal With Neostigmine
Neuromuscular blocking agents (NMBAs) are commonly used in the practice of anesthesiology for skeletal muscle relaxation to facilitate tracheal intubation, mechanical ventilation, and to provide optimal surgical conditions. In order to prevent residual NMB, it is vital to adequately reverse any use of a non-depolarizing NMBA. This was historically done using an anticholinesterase such as neostigmine, which would increase the concentration of acetylcholine at the neuromuscular junction leading to the return of neuromuscular transmission. Unfortunately, there are disadvantages to the use of an anticholinesterase. It was in this context that sugammadex was found to be a valuable addition to the anesthesiologist's armamentarium. It is a modified γ-cyclodextrin that encapsulates the aminosteroid NMBAs rocuronium and vecuronium.
This project is a double-blind randomized placebo-controlled dose-response trial that aims to determine the time taken to achieve adequate reversal comparing five doses of sugammadex as rescue therapy following inadequate reversal with neostigmine. The study team will recruit patients aged 18 years and above from the main operating room and outpatient surgery center at Grady Memorial Hospital who are undergoing elective surgery under general anesthesia, who has received NMB, received neostigmine for NMB reversal, and achieved a TOF count ≥ 3 twitches but not a TOF ratio of 0.9 fifteen minutes after neostigmine was given. Those with a TOF count < 3 twitches will drop out of the study as there are already specified doses of sugammadex for that level of NMB
Read the detailed description
Neuromuscular blocking (NMB) agents are commonly used in the practice of anesthesiology for skeletal muscle relaxation to facilitate tracheal intubation, and may require reversal in order to prevent residual NMB. This was historically done using an anticholinesterase such as neostigmine, which has many adverse effects and may not effectively reverse a deep NMB. However, the introduction of sugammadex was instrumental in allowing the rapid return of neuromuscular function. The FDA has only approved three doses of sugammadex (2 mg/kg, 4 mg/kg and 16 mg/kg) depending on the train of four (TOF) count, which is a qualitative measure of the depth of NMB and ranges from 0 to 4 twitches. Conversely, the TOF ratio is a quantitative measure, is calculated using the ratio of the amplitude of the fourth twitch to the first twitch, and ranges from 0 to 1. A TOF ratio of 0.9 is generally accepted as the minimum threshold to safely extubate a patient, but this information is not always readily accessible as many anesthesia providers do not have a quantitative NMB monitor.
In 2020, Carvalho et al. conducted a meta-analysis of 53 studies (12,664 adult patients) where the pooled residual NMB incidence ranged from 0.115 when quantitative neuromuscular monitoring was used to 0.331 where no neuromuscular monitoring was used. Ravel et al. conducted a meta-analysis of 20 randomized controlled trials (1,923 adult patients), where residual NMB was found in 2.8% of patients who received sugammadex compared to 39% of those who received neostigmine 15 minutes post administration. Concerningly, 60 minutes after administration, 2.1% of the sugammadex group versus 19% of the neostigmine group still had NMB. When expanded to observational studies (58 studies with 25,277 adult patients), the incidence of residual NMB ranged from 0% to 90.5% (median 30%), which was significantly lower (0% to 16%) in the sugammadex group compared to 3.5% to 90.5% in the neostigmine group and 15% to 89% in the spontaneous recovery group.
This project is a double-blind randomized placebo-controlled dose-response trial that aims to determine the time taken to achieve adequate reversal comparing five doses of sugammadex as rescue therapy following inadequate reversal with neostigmine. The study team will recruit patients aged 18 years and above from the main operating room and outpatient surgery center at Grady Memorial Hospital who are undergoing elective surgery under general anesthesia, who has received NMB, received neostigmine for NMB reversal, and achieved a TOF count ≥ 3 twitches but not a TOF ratio of 0.9 fifteen minutes after neostigmine was given. Those with a TOF count < 3 twitches will drop out of the study as there are already specified doses of sugammadex for that level of NMB.
These patients will then be randomized to six groups: 2 mg/kg (the lowest dose approved by the FDA), 1 mg/kg, 0.5 mg/kg, 0.25 mg/kg, 0.125 mg/kg of sugammadex, and placebo. The time taken to reach a TOF ratio of 0.9 thereafter would be measured and compared for statistically significant differences.
- Conditions
- Neuromuscular Blockade
- Being tested
- Sugammadex, Placebo
- Keywords
- Neostigmine, Sugammandex
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SugammadexDrug
Sugammadex is a FDA-approved drug that is in routine clinical use for NMB reversal.
Patients will be randomized to six groups: 2 mg/kg (the lowest dose approved by the FDA), 1 mg/kg, 0.5 mg/kg, 0.25 mg/kg, 0.125 mg/kg of sugammadex and placebo. Doses would be based on actual body weight. The time taken to reach a TOF ratio of 0.9 thereafter would be measured. If the patient fails to achieve this goal by 10 minutes, sugammadex would be given in 2 mg/kg increments until the patient reaches this threshold and can be safely extubated.
PlaceboDrug
Normal saline will be used as placebo. The inclusion of a placebo group would allow us to examine if patients may recover spontaneously over that time without needing any sugammadex at all, and what parameters may predict that subset of patients. It will also improve the dose response modelling, in that randomization has been weighted so that patients who are least likely to need sugammadex (i.e. if they achieved a TOF count of 4 twitches without fade) are more likely to be in the placebo group or at the lowest dose of sugammadex that is being tested.
| Study group | Role | What they receive |
|---|---|---|
| Sugammadex 2 mg/kg | Active comparator | The study team will identify patients who are scheduled to undergo an elective surgery under general anesthesia, received rocuronium for NMB and neostigmine for NMB reversal.
Patients will be randomized using the Emory University REDCap (Research Electronic Data Capture) software to six groups: 2 mg/kg (the lowest dose approved by the FDA), 1 mg/kg, 0.5 mg/kg, 0.25 mg/kg, 0.125 mg/kg of sugammadex and placebo. Doses would be based on actual body weight. The time taken to reach a TOF ratio of 0.9 thereafter would be measured. If the patient fails to achieve this goal by 10 minutes, sugammadex would be given in 2 mg/kg increments until the patient reaches this threshold and can be safely extubated. The TOF ratio would be measured again at 30 minutes after arrival at the PACU to exclude delayed residual NMB with the plan to give further 2 mg/kg doses of sugammadex if detected. Receives: Drug: Sugammadex |
| Sugammadex 1 mg/kg | Experimental | The study team will identify patients who are scheduled to undergo an elective surgery under general anesthesia, received rocuronium for NMB and neostigmine for NMB reversal.
Patients will be randomized using the Emory University REDCap (Research Electronic Data Capture) software to six groups: 2 mg/kg (the lowest dose approved by the FDA), 1 mg/kg, 0.5 mg/kg, 0.25 mg/kg, 0.125 mg/kg of sugammadex and placebo. Doses would be based on actual body weight. The time taken to reach a TOF ratio of 0.9 thereafter would be measured. If the patient fails to achieve this goal by 10 minutes, sugammadex would be given in 2 mg/kg increments until the patient reaches this threshold and can be safely extubated. The TOF ratio would be measured again at 30 minutes after arrival at the PACU to exclude delayed residual NMB with the plan to give further 2 mg/kg doses of sugammadex if detected. Receives: Drug: Sugammadex |
| Sugammadex 0.5 mg/kg | Experimental | The study team will identify patients who are scheduled to undergo an elective surgery under general anesthesia, received rocuronium for NMB and neostigmine for NMB reversal.
Patients will be randomized using the Emory University REDCap (Research Electronic Data Capture) software to six groups: 2 mg/kg (the lowest dose approved by the FDA), 1 mg/kg, 0.5 mg/kg, 0.25 mg/kg, 0.125 mg/kg of sugammadex and placebo. Doses would be based on actual body weight. The time taken to reach a TOF ratio of 0.9 thereafter would be measured. If the patient fails to achieve this goal by 10 minutes, sugammadex would be given in 2 mg/kg increments until the patient reaches this threshold and can be safely extubated. The TOF ratio would be measured again at 30 minutes after arrival at the PACU to exclude delayed residual NMB with the plan to give further 2 mg/kg doses of sugammadex if detected. Receives: Drug: Sugammadex |
| Sugammadex 0.25 mg/kg | Experimental | The study team will identify patients who are scheduled to undergo an elective surgery under general anesthesia, received rocuronium for NMB and neostigmine for NMB reversal.
Patients will be randomized using the Emory University REDCap (Research Electronic Data Capture) software to six groups: 2 mg/kg (the lowest dose approved by the FDA), 1 mg/kg, 0.5 mg/kg, 0.25 mg/kg, 0.125 mg/kg of sugammadex and placebo. Doses would be based on actual body weight. The time taken to reach a TOF ratio of 0.9 thereafter would be measured. If the patient fails to achieve this goal by 10 minutes, sugammadex would be given in 2 mg/kg increments until the patient reaches this threshold and can be safely extubated. The TOF ratio would be measured again at 30 minutes after arrival at the PACU to exclude delayed residual NMB with the plan to give further 2 mg/kg doses of sugammadex if detected. Receives: Drug: Sugammadex |
| Sugammadex 0.125 mg/kg | Experimental | The study team will identify patients who are scheduled to undergo an elective surgery under general anesthesia, received rocuronium for NMB and neostigmine for NMB reversal.
Patients will be randomized using the Emory University REDCap (Research Electronic Data Capture) software to six groups: 2 mg/kg (the lowest dose approved by the FDA), 1 mg/kg, 0.5 mg/kg, 0.25 mg/kg, 0.125 mg/kg of sugammadex and placebo. Doses would be based on actual body weight. The time taken to reach a TOF ratio of 0.9 thereafter would be measured. If the patient fails to achieve this goal by 10 minutes, sugammadex would be given in 2 mg/kg increments until the patient reaches this threshold and can be safely extubated. The TOF ratio would be measured again at 30 minutes after arrival at the PACU to exclude delayed residual NMB with the plan to give further 2 mg/kg doses of sugammadex if detected. Receives: Drug: Sugammadex |
| Placebo | Placebo comparator | The inclusion of a placebo group would allow the study team to examine if patients may recover spontaneously over that time without needing any sugammadex at all, and what parameters may predict that subset of patients. It will also improve the dose response modelling, in that randomization has been weighted so that patients who are least likely to need sugammadex (i.e. if they achieved a TOF count of 4 twitches without fade) are more likely to be in the placebo group or at the lowest dose of sugammadex that is being tested. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Time Taken to Achieve a TOF Ratio of 0.9 After Administration Sugammadex
The time taken to achieve a time of train (TOF) ratio of 0.9 after the use of the intervention drug versus placebo in a patient population that has already received neostigmine for NMB reversal.
Quantitative neuromuscular monitoring will be carried out using electromyography, which measures the TOF ratio every 20 seconds. The TOF count (between 0 to 4) and the TOF ratio (0 to 1) would be measured and recorded at baseline and after administration of the study drug. If the TOF ratio remains < 0.9 after this, or if the patient exhibits any symptoms or signs of residual NMB blockade, a further 2 mg/kg dose of sugammadex would be given until the patient achieves a TOF ratio of 0.9.
Measured: 10 minutes post administration of study drug
Secondary outcomes (1)
The Percentage of Patients Who Achieve a TOF Ratio of 0.9
The percentage of patients who achieve a TOF ratio of 0.9 will be measured within 1 minute, 2 minutes, 5 minutes, and 10 minutes after the administration of the study drug, sugammadex.
Measured: 1 minute, 2 minutes and 10 minutes post administration of study drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2022
- Study start21 Jul 2023
- Primary completion2 Aug 2024
- Study completion2 Aug 2024
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.
- Other trials for Neuromuscular BlockadeStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe 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
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Advancing Translational Sciences (NCATS), Georgia Clinical & Translational Science Alliance
- Responsible party
- Principal investigator, Matthew K Whalin, Emory University
- Investigators
- Matthew Whalin, MD, Principal investigator, Assistant Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05661409
- Sponsor's protocol ID
- STUDY00004369
- Other IDs
- UL1TR002378
- Status last verified
- Aug 2025
- First submitted
- 14 Dec 2022
- Last updated
- 5 Sep 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in the article, after deidentification (text, tables, figures, and appendices).
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Sugammadex as Rescue Therapy Following Inadequate Reversal With Neostigmine
- ClinicalTrials.gov ID
- NCT05661409
- Acronym / sponsor ID
- STUDY00004369
- Conditions
- Neuromuscular Blockade
- Keywords
- Neostigmine, Sugammandex
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- National Center for Advancing Translational Sciences (NCATS), Georgia Clinical & Translational Science Alliance
- Study start
- 21 Jul 2023 (actual)
- Primary completion
- 2 Aug 2024 (actual)
- Study completion
- 2 Aug 2024 (actual)
- First posted
- 22 Dec 2022 (actual)
- Results
- Posted 5 Sep 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Neuromuscular blocking agents (NMBAs) are commonly used in the practice of anesthesiology for skeletal muscle relaxation to facilitate tracheal intubation, mechanical ventilation, and to provide optimal surgical conditions. In order to prevent residual NMB, it is vital to adequately reverse any use of a non-depolarizing NMBA. This was historically done using an anticholinesterase such as neostigmine, which would increase the concentration of acetylcholine at the neuromuscular junction leading to the return of neuromuscular transmission. Unfortunately, there are disadvantages to the use of an anticholinesterase. It was in this context that sugammadex was found to be a valuable addition to the anesthesiologist's armamentarium. It is a modified γ-cyclodextrin that encapsulates the aminosteroid NMBAs rocuronium and vecuronium.
This project is a double-blind randomized placebo-controlled dose-response trial that aims to determine the time taken to achieve adequate reversal comparing five doses of sugammadex as rescue therapy following inadequate reversal with neostigmine. The study team will recruit patients aged 18 years and above from the main operating room and outpatient surgery center at Grady Memorial Hospital who are undergoing elective surgery under general anesthesia, who has received NMB, received neostigmine for NMB reversal, and achieved a TOF count ≥ 3 twitches but not a TOF ratio of 0.9 fifteen minutes after neostigmine was given. Those with a TOF count < 3 twitches will drop out of the study as there are already specified doses of sugammadex for that level of NMB
Detailed description
Neuromuscular blocking (NMB) agents are commonly used in the practice of anesthesiology for skeletal muscle relaxation to facilitate tracheal intubation, and may require reversal in order to prevent residual NMB. This was historically done using an anticholinesterase such as neostigmine, which has many adverse effects and may not effectively reverse a deep NMB. However, the introduction of sugammadex was instrumental in allowing the rapid return of neuromuscular function. The FDA has only approved three doses of sugammadex (2 mg/kg, 4 mg/kg and 16 mg/kg) depending on the train of four (TOF) count, which is a qualitative measure of the depth of NMB and ranges from 0 to 4 twitches. Conversely, the TOF ratio is a quantitative measure, is calculated using the ratio of the amplitude of the fourth twitch to the first twitch, and ranges from 0 to 1. A TOF ratio of 0.9 is generally accepted as the minimum threshold to safely extubate a patient, but this information is not always readily accessible as many anesthesia providers do not have a quantitative NMB monitor.
In 2020, Carvalho et al. conducted a meta-analysis of 53 studies (12,664 adult patients) where the pooled residual NMB incidence ranged from 0.115 when quantitative neuromuscular monitoring was used to 0.331 where no neuromuscular monitoring was used. Ravel et al. conducted a meta-analysis of 20 randomized controlled trials (1,923 adult patients), where residual NMB was found in 2.8% of patients who received sugammadex compared to 39% of those who received neostigmine 15 minutes post administration. Concerningly, 60 minutes after administration, 2.1% of the sugammadex group versus 19% of the neostigmine group still had NMB. When expanded to observational studies (58 studies with 25,277 adult patients), the incidence of residual NMB ranged from 0% to 90.5% (median 30%), which was significantly lower (0% to 16%) in the sugammadex group compared to 3.5% to 90.5% in the neostigmine group and 15% to 89% in the spontaneous recovery group.
This project is a double-blind randomized placebo-controlled dose-response trial that aims to determine the time taken to achieve adequate reversal comparing five doses of sugammadex as rescue therapy following inadequate reversal with neostigmine. The study team will recruit patients aged 18 years and above from the main operating room and outpatient surgery center at Grady Memorial Hospital who are undergoing elective surgery under general anesthesia, who has received NMB, received neostigmine for NMB reversal, and achieved a TOF count ≥ 3 twitches but not a TOF ratio of 0.9 fifteen minutes after neostigmine was given. Those with a TOF count < 3 twitches will drop out of the study as there are already specified doses of sugammadex for that level of NMB.
These patients will then be randomized to six groups: 2 mg/kg (the lowest dose approved by the FDA), 1 mg/kg, 0.5 mg/kg, 0.25 mg/kg, 0.125 mg/kg of sugammadex, and placebo. The time taken to reach a TOF ratio of 0.9 thereafter would be measured and compared for statistically significant differences.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Sugammadex 2 mg/kg | Active comparator | Drug: SugammadexThe study team will identify patients who are scheduled to undergo an elective surgery under general anesthesia, received rocuronium for NMB and neostigmine for NMB reversal. Patients will be randomized using the Emory University REDCap (Research Electronic Data Capture) software to six groups: 2 mg/kg (the lowest dose approved by the FDA), 1 mg/kg, 0.5 mg/kg, 0.25 mg/kg, 0.125 mg/kg of sugammadex and placebo. Doses would be based on actual body weight. The time taken to reach a TOF ratio of 0.9 thereafter would be measured. If the patient fails to achieve this goal by 10 minutes, sugammadex would be given in 2 mg/kg increments until the patient reaches this threshold and can be safely extubated. The TOF ratio would be measured again at 30 minutes after arrival at the PACU to exclude delayed residual NMB with the plan to give further 2 mg/kg doses of sugammadex if detected. |
| Sugammadex 1 mg/kg | Experimental | Drug: SugammadexThe study team will identify patients who are scheduled to undergo an elective surgery under general anesthesia, received rocuronium for NMB and neostigmine for NMB reversal. Patients will be randomized using the Emory University REDCap (Research Electronic Data Capture) software to six groups: 2 mg/kg (the lowest dose approved by the FDA), 1 mg/kg, 0.5 mg/kg, 0.25 mg/kg, 0.125 mg/kg of sugammadex and placebo. Doses would be based on actual body weight. The time taken to reach a TOF ratio of 0.9 thereafter would be measured. If the patient fails to achieve this goal by 10 minutes, sugammadex would be given in 2 mg/kg increments until the patient reaches this threshold and can be safely extubated. The TOF ratio would be measured again at 30 minutes after arrival at the PACU to exclude delayed residual NMB with the plan to give further 2 mg/kg doses of sugammadex if detected. |
| Sugammadex 0.5 mg/kg | Experimental | Drug: SugammadexThe study team will identify patients who are scheduled to undergo an elective surgery under general anesthesia, received rocuronium for NMB and neostigmine for NMB reversal. Patients will be randomized using the Emory University REDCap (Research Electronic Data Capture) software to six groups: 2 mg/kg (the lowest dose approved by the FDA), 1 mg/kg, 0.5 mg/kg, 0.25 mg/kg, 0.125 mg/kg of sugammadex and placebo. Doses would be based on actual body weight. The time taken to reach a TOF ratio of 0.9 thereafter would be measured. If the patient fails to achieve this goal by 10 minutes, sugammadex would be given in 2 mg/kg increments until the patient reaches this threshold and can be safely extubated. The TOF ratio would be measured again at 30 minutes after arrival at the PACU to exclude delayed residual NMB with the plan to give further 2 mg/kg doses of sugammadex if detected. |
| Sugammadex 0.25 mg/kg | Experimental | Drug: SugammadexThe study team will identify patients who are scheduled to undergo an elective surgery under general anesthesia, received rocuronium for NMB and neostigmine for NMB reversal. Patients will be randomized using the Emory University REDCap (Research Electronic Data Capture) software to six groups: 2 mg/kg (the lowest dose approved by the FDA), 1 mg/kg, 0.5 mg/kg, 0.25 mg/kg, 0.125 mg/kg of sugammadex and placebo. Doses would be based on actual body weight. The time taken to reach a TOF ratio of 0.9 thereafter would be measured. If the patient fails to achieve this goal by 10 minutes, sugammadex would be given in 2 mg/kg increments until the patient reaches this threshold and can be safely extubated. The TOF ratio would be measured again at 30 minutes after arrival at the PACU to exclude delayed residual NMB with the plan to give further 2 mg/kg doses of sugammadex if detected. |
| Sugammadex 0.125 mg/kg | Experimental | Drug: SugammadexThe study team will identify patients who are scheduled to undergo an elective surgery under general anesthesia, received rocuronium for NMB and neostigmine for NMB reversal. Patients will be randomized using the Emory University REDCap (Research Electronic Data Capture) software to six groups: 2 mg/kg (the lowest dose approved by the FDA), 1 mg/kg, 0.5 mg/kg, 0.25 mg/kg, 0.125 mg/kg of sugammadex and placebo. Doses would be based on actual body weight. The time taken to reach a TOF ratio of 0.9 thereafter would be measured. If the patient fails to achieve this goal by 10 minutes, sugammadex would be given in 2 mg/kg increments until the patient reaches this threshold and can be safely extubated. The TOF ratio would be measured again at 30 minutes after arrival at the PACU to exclude delayed residual NMB with the plan to give further 2 mg/kg doses of sugammadex if detected. |
| Placebo | Placebo comparator | Drug: PlaceboThe inclusion of a placebo group would allow the study team to examine if patients may recover spontaneously over that time without needing any sugammadex at all, and what parameters may predict that subset of patients. It will also improve the dose response modelling, in that randomization has been weighted so that patients who are least likely to need sugammadex (i.e. if they achieved a TOF count of 4 twitches without fade) are more likely to be in the placebo group or at the lowest dose of sugammadex that is being tested. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients aged 18 years and above who will undergo an elective surgery in the main operating room or outpatient surgery center at Grady Memorial Hospital
- Receive general anesthesia (standardized to sevoflurane for maintenance)
- Receive rocuronium for NMB
- Receive neostigmine for NMB reversal
- Achieve a TOF count of at least 3 twitches but not a TOF ratio of 0.9 fifteen minutes after neostigmine has been given
Key exclusion criteria (10 listed)
- Pregnancy and/or lactating
- BMI ≥ 40
- Severe renal impairment, i.e. chronic kidney disease stages IV and V as defined by GFR < 30 ml/min/1.73 m2
- Severe hepatic impairment, i.e. Child-Pugh score C
- Pre-existing neuromuscular disease
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 |
|---|---|---|
| SugammadexSugammadex is a FDA-approved drug that is in routine clinical use for NMB reversal. Patients will be randomized to six groups: 2 mg/kg (the lowest dose approved by the FDA), 1 mg/kg, 0.5 mg/kg, 0.25 mg/kg, 0.125 mg/kg of sugammadex and placebo. Doses would be based on actual body weight. The time taken to reach a TOF ratio of 0.9 thereafter would be measured. If the patient fails to achieve this goal by 10 minutes, sugammadex would be given in 2 mg/kg increments until the patient reaches this threshold and can be safely extubated. | Drug | Sugammadex 0.125 mg/kg, Sugammadex 0.25 mg/kg, Sugammadex 0.5 mg/kg, Sugammadex 1 mg/kg, Sugammadex 2 mg/kg |
| PlaceboNormal saline will be used as placebo. The inclusion of a placebo group would allow us to examine if patients may recover spontaneously over that time without needing any sugammadex at all, and what parameters may predict that subset of patients. It will also improve the dose response modelling, in that randomization has been weighted so that patients who are least likely to need sugammadex (i.e. if they achieved a TOF count of 4 twitches without fade) are more likely to be in the placebo group or at the lowest dose of sugammadex that is being tested. | Drug | Placebo |
Primary outcome
The Time Taken to Achieve a TOF Ratio of 0.9 After Administration Sugammadex
Time frame: 10 minutes post administration of study drug
The time taken to achieve a time of train (TOF) ratio of 0.9 after the use of the intervention drug versus placebo in a patient population that has already received neostigmine for NMB reversal. Quantitative neuromuscular monitoring will be carried out using electromyography, which measures the TOF ratio every 20 seconds. The TOF count (between 0 to 4) and the TOF ratio (0 to 1) would be measured and recorded at baseline and after administration of the study drug. If the TOF ratio remains < 0.9 after this, or if the patient exhibits any symptoms or signs of residual NMB blockade, a further 2 mg/kg dose of sugammadex would be given until the patient achieves a TOF ratio of 0.9.
1 secondary outcome
The Percentage of Patients Who Achieve a TOF Ratio of 0.9
Time frame: 1 minute, 2 minutes and 10 minutes post administration of study drug
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in the article, after deidentification (text, tables, figures, and appendices).
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Airway Management, Supraglottic Airway Device Insertion
RecruitingPhase 4
Risk of Acute Complications With Rocuronium vs Cisatracurium in Patients With Chronic Kidney Disease
Post Operative Pulmonary Complications, Neuromuscular Blockade
Not yet recruiting
Blast-related Regional Anaesthesia and Peripheral nerVe Injury Evaluation
Nerve Block, Nerve Blocks
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.
Matthew Whalin, MD principal investigator
Assistant Professor
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 in people with Neuromuscular Blockade, run by Emory University at 1 site in United States.
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 6 inclusion and 10 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 5 Sep 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 United States. 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 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 5 Sep 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?
The Time Taken to Achieve a TOF Ratio of 0.9 After Administration Sugammadex (time frame: 10 minutes post administration of study drug). 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 5 Sep 2025.