Deep Neuromuscular BlockadeNCT05841316
The ED95 Dose of Sugammadex to Reverse Rocuronium-Induced Deep Neuromuscular Block Back to Shallow Neuromuscular Block
An observational study of Deep Neuromuscular Blockade and Anesthesia, General, run by Ankara University.
Trial summary
In the European Society of Anaesthesiology and Intensive Care (ESAIC) guideline on the use of neuromuscular blockers published in 2023, it was suggested that sugammadex could be used to reverse deep and moderate neuromuscular blockade, and that neostigmine could be used to reverse superficial neuromuscular block… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Deep Neuromuscular Blockade, Anesthesia, General
- What is being tested?
- Sugammadex
- Type of treatment
- Injection or infusion
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Oct 2023to 1 Dec 2023
- How long will I take part?
- 1 Day
- Phase
- Observational
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All ASA 1 and 2 patients undergoing elective surgery with normal BMI
Who may be able to join
- BMI: 18.5-24.9 kg/m2
- ASA 1 and 2
- Patients undergoing elective surgery
Who cannot join
- Allergic reactions to study drugs
- Planned rapid sequence anesthesia induction
- Patient refusal
- Emergence surgery
- Neuromuscular diseases
- Renal disease or failure with elevated creatinine above 2.0 mg/dL
- Liver failure
Trial locations and contacts
No sites are listed yet.
About this study
Official title: The ED95 Dose Determined by Classical Train-of-four Ratio of Sugammadex to Reverse Rocuronium-Induced Deep Neuromuscular Block Back to Shallow Neuromuscular Block
In the European Society of Anaesthesiology and Intensive Care (ESAIC) guideline on the use of neuromuscular blockers published in 2023, it was suggested that sugammadex could be used to reverse deep and moderate neuromuscular blockade, and that neostigmine could be used to reverse superficial neuromuscular block (expressed as Train-of-Four Ratio (TOFR) 0.4 and above) to TOFR 0.9. Therefore, it has been hypothesized that a transition from deep neuromuscular block to superficial neuromuscular block can be achieved with lower than standard dose of sugammadex, followed by usual dose of neostigmine which results complete neuromuscular recovery from superficial neuromuscular block.
This study is planned with 2 stages. In the first phase of the study, the main goal is to determine the dose of sugammadex that would reverse the rocuronium induced deep neuromuscular block (PTC 1 to 3) to superficial neuromuscular block (TOFR: 0.4) in 95% of patients in 5 minutes following administration.
Read the detailed description
Laparoscopic surgery also known as minimally invasive surgery is a type of surgical procedure which allows a surgeon to access the inside of the abdomen and pelvis without having to make large incisions in the skin. As the administration of deep neuromuscular block has been shown to improve surgical conditions in laparoscopic abdominal surgery, patients are usually kept under deep neuromuscular block using either intermittent bolus or continous infusion of neuromuscular blocking drugs such as rocuronium during the surgical procedure (1). Due to small incisions of fascia and skin, the duration between the completion of intra-abdominal surgical manipulation in which the patient is usually under rocuronium-induced deep neuromuscular block (RIDeNB) and the end of skin sutures in which the patient should be closed to fully recover from RIDeNB is often short. However, the time interval required for reversing RIDeNB may be quite longer if spontaneous neuromuscular recovery is allowed. Therefore, sugammadex of 4 mg/kg is usually recommended to shorten the duration of RIDeNB reversal (2).
The incidence of an unplanned re-intubation which occurs shortly after a failed extubation is approximately 0.04-0.09% (3,4). Although the incidence seems quite low, it may be a life threatening adverse event. In case of unplanned re-intubation after the administration of 4 mg/kg sugammadex to reverse RIDeNB, the anesthesiologist may choose to give a non-steroidal neuromuscular blocker or 1,2 mg/kg of a high dose of rocuronium. With re-administration of 1.2 mg/kg rocuronium up to 30 minutes after sugammadex administration, the onset of neuromuscular blockade again may be prolonged to approximately 4 minutes and also the duration of neuromuscular blockade may be shortened to approximately 15 minutes. Due to the possibility of re-intubation after every single extubation, the lower the dose of sugammadex administered during the recovery phase of RIDeNM, the less the need for the dose of rocuronium to be applied for the next intubation attempt or better re-intubation conditions will be provided even if the same dose is applied. To lower the standard reversal dose of sugammadex, it is assumed that gradual recovery can be achieved with the combination of sugammadex and neostigmine to achieve a complete neuromuscular recovery with an effective, reliable and lower cost manner.
In the ESAIC guideline on the use of neuromuscular blockers published in 2023, it was suggested that sugammadex could be used to reverse deep and moderate neuromuscular blockade, and that neostigmine could be used to reverse superficial neuromuscular block (expressed as TOFR 0.4 and above) to TOFR 0.9 (5). Therefore, it has been hypothesized that a transition from deep neuromuscular block to superficial neuromuscular block can be achieved with lower than standard dose of sugammadex, followed by usual dose of neostigmine which results complete neuromuscular recovery from superficial neuromuscular block.
This study is planned with 2 stages. In the first phase of the study, the main goal is to determine the dose of sugammadex that would reverse the rocuronium induced deep neuromuscular block (PTC 1 to 3) to superficial neuromuscular block (TOFR: 0.4) in 95% of patients in 5 minutes following administration.
- Conditions
- Deep Neuromuscular Blockade, Anesthesia, General
- Being tested
- Sugammadex
- Keywords
- neuromuscular block, sugammadex, ED95, rocuronium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SugammadexDrug
During the surgery, the desired level of neuromuscular block will be deep and followed by post-tetanic-count (PTC) of 1 to 3 in every 5 minutes. 0.3-1mg/kg/h rocuronium will be infused to ensure PTC of 1 to 3.
At the end of the surgery, 0,6 mg sugammadex will be given as a bolus in the first patient of the study. The duration between the completion of sugammadex injection and the first measurement of Train-of-four ratio (TOFR) of 0.4 will be recorded.
If the TOFR is achieved to 0.4 after sugammadex bolus of 0,6 mg/kg in 5 minutes, the result of reversal will be evaluated as positive. The consecutive patient will be given the same or decreased dose of sugammadex by 0,2 mg/kg according to the randomisation scheme.
If the patient fails to recover from deep neuromuscular block to superficial block in 5 minutes after a given dose of sugammadex, the consecutive patient will be administered increased dose of sugammadex by 0,2 mg/kg.
| Study group | Role | What they receive |
|---|---|---|
| Sugammadex ED95% | Sugammadex 0.6 mg/kg will be given in the first patient. The primary outcome is the success of recovery from deep (PTC:1-3) to superficial neuromuscular block (TOFR: 0.4) in 5 minutes after the administration of sugammadex.
In case of success, the next patient will be given the same or reduced dose of 0.2 mg/kg sugammadex according to the randomisation scheme.
In case of failure, the next patient will be given an increased dose of 0.2 mg/kg sugammadex. Receives: Drug: Sugammadex |
What is being measured
The primary outcome is the main question the study is designed to answer.
ED95 of sugammadex
The dose of sugammadex to provide reversal from deep to superficial rocuronium induced neuromuscular blockade in 5 minutes after bolus administration in 95% of patients
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2023
- Study startOct 2023 (estimated)
- Primary completionDec 2023 (estimated)
- Study completion1 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Deep Neuromuscular BlockadeStudies of the same condition, open and under way.
- More trials run by Ankara 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Ankara University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Menekse Ozcelik, Ankara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05841316
- Sponsor's protocol ID
- 95
- Status last verified
- Aug 2023
- First submitted
- 22 Apr 2023
- Last updated
- 9 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Fuchs-Buder T, Schmartz D, Baumann C, Hilt L, Nomine-Criqui C, Meistelman C, Brunaud L. Deep neuromuscular blockade improves surgical conditions during gastric bypass surgery for morbid obesity: A randomised controlled trial. Eur J Anaesthesiol. 2019 Jul;36(7):486-493. doi: 10.1097/EJA.0000000000000996.
PubMed 30985536Chen S, Zhang Y, Che L, Shen L, Huang Y. Risk factors for unplanned reintubation caused by acute airway compromise after general anesthesia: a case-control study. BMC Anesthesiol. 2021 Jan 12;21(1):17. doi: 10.1186/s12871-021-01238-4.
PubMed 33435881Banik RK, Honeyfield K, Qureshi S, Reddy SG. Incidence and Mortality Rate of Perioperative Reintubation: Case Series of 196 Patients. AANA J. 2021 Dec;89(6):476-479.
PubMed 34809752Fuchs-Buder T, Romero CS, Lewald H, Lamperti M, Afshari A, Hristovska AM, Schmartz D, Hinkelbein J, Longrois D, Popp M, de Boer HD, Sorbello M, Jankovic R, Kranke P. Peri-operative management of neuromuscular blockade: A guideline from the European Society of Anaesthesiology and Intensive Care. Eur J Anaesthesiol. 2023 Feb 1;40(2):82-94. doi: 10.1097/EJA.0000000000001769. Epub 2022 Nov 15.
PubMed 36377554
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The ED95 Dose Determined by Classical Train-of-four Ratio of Sugammadex to Reverse Rocuronium-Induced Deep Neuromuscular Block Back to Shallow Neuromuscular Block
- ClinicalTrials.gov ID
- NCT05841316
- Acronym / sponsor ID
- 95
- Conditions
- Deep Neuromuscular Blockade, Anesthesia, General
- Keywords
- neuromuscular block, sugammadex, ED95, rocuronium
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Ankara UniversityUniversity, hospital or other
- Study start
- Oct 2023 (estimated)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- 1 Dec 2023 (estimated)
- First posted
- 3 May 2023 (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 the European Society of Anaesthesiology and Intensive Care (ESAIC) guideline on the use of neuromuscular blockers published in 2023, it was suggested that sugammadex could be used to reverse deep and moderate neuromuscular blockade, and that neostigmine could be used to reverse superficial neuromuscular block (expressed as Train-of-Four Ratio (TOFR) 0.4 and above) to TOFR 0.9. Therefore, it has been hypothesized that a transition from deep neuromuscular block to superficial neuromuscular block can be achieved with lower than standard dose of sugammadex, followed by usual dose of neostigmine which results complete neuromuscular recovery from superficial neuromuscular block.
This study is planned with 2 stages. In the first phase of the study, the main goal is to determine the dose of sugammadex that would reverse the rocuronium induced deep neuromuscular block (PTC 1 to 3) to superficial neuromuscular block (TOFR: 0.4) in 95% of patients in 5 minutes following administration.
Detailed description
Laparoscopic surgery also known as minimally invasive surgery is a type of surgical procedure which allows a surgeon to access the inside of the abdomen and pelvis without having to make large incisions in the skin. As the administration of deep neuromuscular block has been shown to improve surgical conditions in laparoscopic abdominal surgery, patients are usually kept under deep neuromuscular block using either intermittent bolus or continous infusion of neuromuscular blocking drugs such as rocuronium during the surgical procedure (1). Due to small incisions of fascia and skin, the duration between the completion of intra-abdominal surgical manipulation in which the patient is usually under rocuronium-induced deep neuromuscular block (RIDeNB) and the end of skin sutures in which the patient should be closed to fully recover from RIDeNB is often short. However, the time interval required for reversing RIDeNB may be quite longer if spontaneous neuromuscular recovery is allowed. Therefore, sugammadex of 4 mg/kg is usually recommended to shorten the duration of RIDeNB reversal (2).
The incidence of an unplanned re-intubation which occurs shortly after a failed extubation is approximately 0.04-0.09% (3,4). Although the incidence seems quite low, it may be a life threatening adverse event. In case of unplanned re-intubation after the administration of 4 mg/kg sugammadex to reverse RIDeNB, the anesthesiologist may choose to give a non-steroidal neuromuscular blocker or 1,2 mg/kg of a high dose of rocuronium. With re-administration of 1.2 mg/kg rocuronium up to 30 minutes after sugammadex administration, the onset of neuromuscular blockade again may be prolonged to approximately 4 minutes and also the duration of neuromuscular blockade may be shortened to approximately 15 minutes. Due to the possibility of re-intubation after every single extubation, the lower the dose of sugammadex administered during the recovery phase of RIDeNM, the less the need for the dose of rocuronium to be applied for the next intubation attempt or better re-intubation conditions will be provided even if the same dose is applied. To lower the standard reversal dose of sugammadex, it is assumed that gradual recovery can be achieved with the combination of sugammadex and neostigmine to achieve a complete neuromuscular recovery with an effective, reliable and lower cost manner.
In the ESAIC guideline on the use of neuromuscular blockers published in 2023, it was suggested that sugammadex could be used to reverse deep and moderate neuromuscular blockade, and that neostigmine could be used to reverse superficial neuromuscular block (expressed as TOFR 0.4 and above) to TOFR 0.9 (5). Therefore, it has been hypothesized that a transition from deep neuromuscular block to superficial neuromuscular block can be achieved with lower than standard dose of sugammadex, followed by usual dose of neostigmine which results complete neuromuscular recovery from superficial neuromuscular block.
This study is planned with 2 stages. In the first phase of the study, the main goal is to determine the dose of sugammadex that would reverse the rocuronium induced deep neuromuscular block (PTC 1 to 3) to superficial neuromuscular block (TOFR: 0.4) in 95% of patients in 5 minutes following administration.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sugammadex ED95% | – | Drug: SugammadexSugammadex 0.6 mg/kg will be given in the first patient. The primary outcome is the success of recovery from deep (PTC:1-3) to superficial neuromuscular block (TOFR: 0.4) in 5 minutes after the administration of sugammadex. In case of success, the next patient will be given the same or reduced dose of 0.2 mg/kg sugammadex according to the randomisation scheme. In case of failure, the next patient will be given an increased dose of 0.2 mg/kg sugammadex. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All ASA 1 and 2 patients undergoing elective surgery with normal BMI
Key inclusion criteria (3 listed)
- BMI: 18.5-24.9 kg/m2
- ASA 1 and 2
- Patients undergoing elective surgery
Key exclusion criteria (7 listed)
- Allergic reactions to study drugs
- Planned rapid sequence anesthesia induction
- Patient refusal
- Emergence surgery
- Neuromuscular diseases
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 |
|---|---|---|
| SugammadexDuring the surgery, the desired level of neuromuscular block will be deep and followed by post-tetanic-count (PTC) of 1 to 3 in every 5 minutes. 0.3-1mg/kg/h rocuronium will be infused to ensure PTC of 1 to 3. At the end of the surgery, 0,6 mg sugammadex will be given as a bolus in the first patient of the study. The duration between the completion of sugammadex injection and the first measurement of Train-of-four ratio (TOFR) of 0.4 will be recorded. If the TOFR is achieved to 0.4 after sugammadex bolus of 0,6 mg/kg in 5 minutes, the result of reversal will be evaluated as positive. The consecutive patient will be given the same or decreased dose of sugammadex by 0,2 mg/kg according to the randomisation scheme. If the patient fails to recover from deep neuromuscular block to superficial block in 5 minutes after a given dose of sugammadex, the consecutive patient will be administered increased dose of sugammadex by 0,2 mg/kg. | Drug | Sugammadex ED95% |
Primary outcome
ED95 of sugammadex
Time frame: 5 minutes
The dose of sugammadex to provide reversal from deep to superficial rocuronium induced neuromuscular blockade in 5 minutes after bolus administration in 95% of patients
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2023.
- Results publication: PubMed 30985536Fuchs-Buder T, Schmartz D, Baumann C, Hilt L, Nomine-Criqui C, Meistelman C, Brunaud L. Deep neuromuscular blockade improves surgical conditions during gastric bypass surgery for morbid obesity: A randomised controlled trial. Eur J Anaesthesiol. 2019 Jul;36(7):486-493. doi: 10.1097/EJA.0000000000000996.
- Results publication: PubMed 33435881Chen S, Zhang Y, Che L, Shen L, Huang Y. Risk factors for unplanned reintubation caused by acute airway compromise after general anesthesia: a case-control study. BMC Anesthesiol. 2021 Jan 12;21(1):17. doi: 10.1186/s12871-021-01238-4.
- Results publication: PubMed 34809752Banik RK, Honeyfield K, Qureshi S, Reddy SG. Incidence and Mortality Rate of Perioperative Reintubation: Case Series of 196 Patients. AANA J. 2021 Dec;89(6):476-479.
- Results publication: PubMed 36377554Fuchs-Buder T, Romero CS, Lewald H, Lamperti M, Afshari A, Hristovska AM, Schmartz D, Hinkelbein J, Longrois D, Popp M, de Boer HD, Sorbello M, Jankovic R, Kranke P. Peri-operative management of neuromuscular blockade: A guideline from the European Society of Anaesthesiology and Intensive Care. Eur J Anaesthesiol. 2023 Feb 1;40(2):82-94. doi: 10.1097/EJA.0000000000001769. Epub 2022 Nov 15.
- Individual participant dataSharing planned: Undecided
Related trials for Deep Neuromuscular Blockade
Not yet recruitingObservational study
Sugammadex Timing and Recovery Profile in Pediatric Adenotonsillectomy
Neuromuscular Blockade, Delayed Emergence From Anesthesia
Active, not recruiting
Comparative Study Between the Effects of Deep Versus Moderate Neuromuscular Blockade on Postoperative Recovery and Immune Function in Patients Undergoing Total Hip Replacement Surgery.
Immune Responses, Post Operative Recovery
Recruiting
Deep Versus Moderate Neuromuscular Blocking
Change in Serum Levels of the Estimated Inflammatory Cytokines, Total Dose of IO Fentanyl
Recruiting
Deep Neuromuscular Blockade and a Low-Residue Diet for the Surgical Field in vNOTES Hysterectomy
Leiomyoma, Uterine, Benign Gynecological Disease
Recruiting
Comparison of Two Quantitative EMG Monitors for Deep Neuromuscular Block in Laparoscopic/Robotic and VATS Surgery
Neuromuscular Blockade
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.
Questions about this trial
What is this clinical trial studying?
An observational study of Deep Neuromuscular Blockade and Anesthesia, General, run by Ankara University.
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 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 9 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
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 Menekse Ozcelik, MD (+905333521400, ozcelikmenekse@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ED95 of sugammadex (time frame: 5 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 NCT05841316, which also lists 4 linked publications.
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 Aug 2023.