Residual Neuromuscular BlockNCT05228223
Comparison of Sugammadex and Sugammadex-neostigmine Combination in the Antagonism of Moderate Neuromuscular Block
A study testing Neuromuscular monitoring, reverse of NMB with sugammadex and reverse of NMB with Sugammadex and neostigmin low dose in people with Residual Neuromuscular Block and Neuromuscular Blockade Monitoring, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
Trial summary
In this prospective randomized controlled study the investigators compare the sugammadex-neostigmine combination and single dose sugammadex in terms of side effects and cost for the antagonism of moderate neuromuscular block induced by rocuronium. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Residual Neuromuscular Block, Neuromuscular Blockade Monitoring
- What is being tested?
- Neuromuscular monitoring, reverse of NMB with sugammadex and reverse of NMB with Sugammadex and neostigmin low dose
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Feb 2022to Jun 2022
- Phase
- Interventional
- 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 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- elective general anesthesia
- Female gender
- Between the ages of 18-65
Who cannot join
- ASA ≥ 3
- Pregnancy
- Contraindication to use of anesthetic drugs
- Kidney failure
- Liver failure
- Heart failure
Show all 13Show fewer
- BMI <18 and BMI > 35 kg/m2
- anticipated difficult airway
- neuromuscular disease
- Use of drugs that impair neuromuscular transmission
- Patients who develop unexpected massive hemorrhage
- Those who do not have the ability to read, understand and sign the consent form
- Refusal of patient
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Sugammadex and Sugammadex-neostigmine Combination in the Antagonism of Moderate Neuromuscular Block Induced by Rocuronium: A Prospective Randomized Cotrolled Study
In this prospective randomized controlled study the investigators compare the sugammadex-neostigmine combination and single dose sugammadex in terms of side effects and cost for the antagonism of moderate neuromuscular block induced by rocuronium.
Read the detailed description
Sugammadex is a novel drug used to reverse neuromuscular blockade. It shows its effect by binding with steroid neuromuscular agents at a ratio of 1:1. Compared to anticholinesterase and other neuromuscular reverse agents, sugammadex shows less cholinergic side effects and less residual muscle relaxation. Besides all these, sugammadex reverses neuromuscular blockade very quickly. In addition to these benefits, it has side effects such as hypersensitivity and this side effect can be seen more at high doses. In addition, sugammadex is more costly than other neuromuscular reverse agents.
In this prospective randomized controlled study the investigators compare the sugammadex-neostigmine combination and single dose sugammadex in terms of side effects and cost for the antagonism of moderate neuromuscular block induced by rocuronium.
- Being tested
- Neuromuscular monitoring, reverse of NMB with sugammadex, reverse of NMB with Sugammadex and neostigmin low dose, reverse of NMB with Sugammadex and neostigmin high dose
- Keywords
- Sugammadex, Neostigmine, Neuromuscular Blockade Monitoring, Postoperative Nausea and Vomiting, Delayed Emergence from Anesthesia, Postoperative Complications, Rocuronium, Residual Neuromuscular Block
- Medical subject headings
- Delayed Emergence from Anesthesia, Postoperative Nausea and Vomiting, Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neuromuscular monitoringDiagnostic test
TOF monitoring
reverse of NMB with sugammadexOther
Patients reversed with Sugammadex 2mg/kg after TOF count is 1-2.
reverse of NMB with Sugammadex and neostigmin low doseOther
Patients reversed with Sugammadex 1mg/kg + Neostigmin 0.02 mg/kg
reverse of NMB with Sugammadex and neostigmin high doseOther
patients reversed with sugammadex 1.5 mg/kg + Neostigmin 0.02 mg/kg
| Study group | Role | What they receive |
|---|---|---|
| Group S | Active comparator | Patients reversed with Sugammadex 2mg/kg after TOF count is 1-2. Receives: Diagnostic Test: Neuromuscular monitoring; Other: reverse of NMB with sugammadex |
| Group SN1 | Active comparator | Patients reversed with Sugammadex 1mg/kg + Neostigmin 0.02 mg/kg after TOF count is 1-2. Receives: Diagnostic Test: Neuromuscular monitoring; Other: reverse of NMB with Sugammadex and neostigmin low dose |
| Grup SN2 | Active comparator | Patients reversed with sugammadex 1.5 mg/kg + Neostigmin 0.02 mg/kg after TOF count is 1-2. Receives: Diagnostic Test: Neuromuscular monitoring; Other: reverse of NMB with Sugammadex and neostigmin high dose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Residual curarization rate
Pecents of Patients TOFR<0.9
Measured: through study completion an average of 3 months
SPO2
peripheric oxygen saturation
Measured: through study completion an average of 3 months
MAP
Mean arterial pressure
Measured: through study completion an average of 3 months
HR
Heart Rate
Measured: through study completion an average of 3 months
Secondary outcomes (2)
PONV
Postoperative nausea and vomiting
Measured: through study completion an average of 3 months
Time to Return of bowel movements
when patients' bowel movements return
Measured: through study completion an average of 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2022
- Study start1 Feb 2022 (estimated)
- Primary completionMay 2022 (estimated)
- Study completionJun 2022 (estimated)
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 Residual Neuromuscular BlockStudies of the same condition, open and under way.
- More trials run by Ankara City Hospital BilkentThe 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 N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective randomized controlled double blind study
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ankara City Hospital Bilkent
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, aysun postaci, Ankara City Hospital Bilkent
- Investigators
- Aysun Postacı, Principal investigator, Ankara City Hospital Bilkent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05228223
- Sponsor's protocol ID
- E1-21-1914
- Status last verified
- Jan 2022
- First submitted
- 19 Sep 2021
- Last updated
- 8 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Postaci A, Durgut R, Aytac BG, Ceyhan M. Effect of sugammadex with neostigmine on postoperative bowel function and on recovery of neuromuscular functions: A randomized controlled trial. Medicine (Baltimore). 2024 Sep 13;103(37):e39623. doi: 10.1097/MD.0000000000039623.
PubMed 39287249
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Sugammadex and Sugammadex-neostigmine Combination in the Antagonism of Moderate Neuromuscular Block Induced by Rocuronium: A Prospective Randomized Cotrolled Study
- ClinicalTrials.gov ID
- NCT05228223
- Acronym / sponsor ID
- E1-21-1914
- Keywords
- Sugammadex, Neostigmine, Neuromuscular Blockade Monitoring, Postoperative Nausea and Vomiting, Delayed Emergence from Anesthesia, Postoperative Complications, Rocuronium, Residual Neuromuscular Block
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Ankara City Hospital BilkentUniversity, hospital or other
- Study start
- 1 Feb 2022 (estimated)
- Primary completion
- May 2022 (estimated)
- Study completion
- Jun 2022 (estimated)
- First posted
- 8 Feb 2022 (actual)
- 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.
In this prospective randomized controlled study the investigators compare the sugammadex-neostigmine combination and single dose sugammadex in terms of side effects and cost for the antagonism of moderate neuromuscular block induced by rocuronium.
Detailed description
Sugammadex is a novel drug used to reverse neuromuscular blockade. It shows its effect by binding with steroid neuromuscular agents at a ratio of 1:1. Compared to anticholinesterase and other neuromuscular reverse agents, sugammadex shows less cholinergic side effects and less residual muscle relaxation. Besides all these, sugammadex reverses neuromuscular blockade very quickly. In addition to these benefits, it has side effects such as hypersensitivity and this side effect can be seen more at high doses. In addition, sugammadex is more costly than other neuromuscular reverse agents.
In this prospective randomized controlled study the investigators compare the sugammadex-neostigmine combination and single dose sugammadex in terms of side effects and cost for the antagonism of moderate neuromuscular block induced by rocuronium.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Prospective randomized controlled double blind study
| Arm | Type | Receives |
|---|---|---|
| Group S | Active comparator | Diagnostic Test: Neuromuscular monitoring, Other: reverse of NMB with sugammadexPatients reversed with Sugammadex 2mg/kg after TOF count is 1-2. |
| Group SN1 | Active comparator | Diagnostic Test: Neuromuscular monitoring, Other: reverse of NMB with Sugammadex and neostigmin low dosePatients reversed with Sugammadex 1mg/kg + Neostigmin 0.02 mg/kg after TOF count is 1-2. |
| Grup SN2 | Active comparator | Diagnostic Test: Neuromuscular monitoring, Other: reverse of NMB with Sugammadex and neostigmin high dosePatients reversed with sugammadex 1.5 mg/kg + Neostigmin 0.02 mg/kg after TOF count is 1-2. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- elective general anesthesia
- Female gender
- Between the ages of 18-65
Key exclusion criteria (13 listed)
- ASA ≥ 3
- Pregnancy
- Contraindication to use of anesthetic drugs
- Kidney failure
- Liver failure
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 |
|---|---|---|
| Neuromuscular monitoringTOF monitoring | Diagnostic test | Group S, Group SN1, Grup SN2 |
| reverse of NMB with sugammadexPatients reversed with Sugammadex 2mg/kg after TOF count is 1-2. | Other | Group S |
| reverse of NMB with Sugammadex and neostigmin low dosePatients reversed with Sugammadex 1mg/kg + Neostigmin 0.02 mg/kg | Other | Group SN1 |
| reverse of NMB with Sugammadex and neostigmin high dosepatients reversed with sugammadex 1.5 mg/kg + Neostigmin 0.02 mg/kg | Other | Grup SN2 |
Primary outcome
Residual curarization rate
Time frame: through study completion an average of 3 months
Pecents of Patients TOFR<0.9
SPO2
Time frame: through study completion an average of 3 months
peripheric oxygen saturation
MAP
Time frame: through study completion an average of 3 months
Mean arterial pressure
HR
Time frame: through study completion an average of 3 months
Heart Rate
2 secondary outcomes
PONV
Time frame: through study completion an average of 3 months
Time to Return of bowel movements
Time frame: through study completion an average of 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2022.
- Derived from this study: PubMed 39287249Postaci A, Durgut R, Aytac BG, Ceyhan M. Effect of sugammadex with neostigmine on postoperative bowel function and on recovery of neuromuscular functions: A randomized controlled trial. Medicine (Baltimore). 2024 Sep 13;103(37):e39623. doi: 10.1097/MD.0000000000039623.
- 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.
Aysun Postacı principal investigator
Ankara City Hospital Bilkent
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neuromuscular monitoring, reverse of NMB with sugammadex and reverse of NMB with Sugammadex and neostigmin low dose in people with Residual Neuromuscular Block and Neuromuscular Blockade Monitoring, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
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 13 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 8 Feb 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 Turkey (Türkiye). 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.
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 Aysun Postacı (+9005323520383, aysunposta@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Residual curarization rate (time frame: through study completion an average of 3 months). The study lists 4 primary outcomes in all. 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 NCT05228223, 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 8 Feb 2022; AzTrials last refreshed its copy on 8 Nov 2026.