Neuromuscular BlockadeNCT04720573
Reversal of Neuromuscular Blockade and Perioperative Arrhythmias
A study testing Neostigmine and Sugammadex in people with Neuromuscular Blockade, run by Başakşehir Çam & Sakura City Hospital at 1 site in Turkey (Türkiye).
Trial summary
Patients scheduled for elective abdominopelvic laparoscopic surgery under general anesthesia were included. Rocuronium was used for the neuromuscular blockade (NMB) and the level of NMB was monitored with train-of-four (TOF) measurements. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Neuromuscular Blockade
- What is being tested?
- Neostigmine and Sugammadex
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2019to 1 Nov 2019
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Planned abdominopelvic surgery under general anesthesia
- ASA II-IV
- Willing to give consent
Who cannot join
- Significantly impaired left ventricular systolic function (ejection fraction < 40%)
- Significant ongoing arrhythmia (sinus bradycardia with a heart rate below 40 beats/min, Mobitz Type II or 3rd-grade atrioventricular block, persistent or permanent atrial flutter or fibrillation, bigeminal or trigeminal ventricular premature beats, documented ventricular tachycardia)
- Severely reduced renal function (glomerular filtration rate < 30 ml/min/1.73 m2)
- Severe respiratory diseases, neuromuscular disorders, and known allergy to anesthetic agents or adjuvants
- Pregnancy and breastfeeding
- Observing the typical signs of a channelopathy (short QT syndrome, long QT syndrome, Brugada syndrome, etc.) and history of recent medical therapy with agents exhibiting a high probability of QT prolongation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Influence of the Neuromuscular Blockade and Its Reversal on Perioperative Arrhythmias
Patients scheduled for elective abdominopelvic laparoscopic surgery under general anesthesia were included. Rocuronium was used for the neuromuscular blockade (NMB) and the level of NMB was monitored with train-of-four (TOF) measurements. The participants from whom informed consent had been received were allocated to two groups according to the agent used for reversal of NMB, sugammadex, or neostigmine. The ECG recordings of the subjects were followed with a rhythm Holter device throughout the procedure until the postoperative 12th hour. Additionally, preoperative and immediate postoperative 12-lead ECGs were evaluated for corrected QT calculations and QT dispersion. Proarrhythmogenicity was assessed with QT related measurements. The documented arrhythmic events on the Holter monitoring were designated as clinical end-points.
Read the detailed description
Eighty consecutive patients, to whom an elective abdominopelvic surgery under general anesthesia was planned, were included in the study. Participants were allocated to two groups considering the agent to be used for the reversal of neuromuscular blockade by closed-envelope randomization. Neostigmine was used for this purpose in Group N, while sugammadex was used in Group S. Demographic features including hypertension, diabetes mellitus, presence of coronary artery disease, heart failure, and previous arrhythmia were noted. Body mass index was calculated with the Du Bois method. In the operation room, heart rate, blood pressure, body temperature, arterial oxygen saturation, and TOF ratio were recorded. General anesthesia was induced with midazolam, fentanyl, and propofol; and maintained by remifentanil and sevoflurane. In Group N, 50 mcg/kg neostigmine and 20 mcg/kg atropine were used for NMB reversal. In Group S, reversal was achieved by the administration of sugammadex at a dose of 2 mg/kg. QT interval was measured in leads DII or V5 and adjusted to the heart rate by the Bazzett formula. QTc values at the baseline and postoperative ECGs were recorded and presented with milliseconds. An increase of over 60 ms in QTc interval or a postoperative measurement over 500 ms were assumed to be distinctly abnormal. QT dispersion was calculated by extracting the minimum QT length from the maximum QT length in 12-lead ECG. In rhythm holter monitoring, minimum and mean heart rates and specific arrhythmic events were recorded. In the heart rate variability analysis, the standard deviation of the interbeat intervals of normal sinus beats (SDNN) and the root mean square of successive differences between normal heartbeats (rMSSD) were calculated. The following events were designated as clinical end-points.
- Pause (no waves on ECG recording at least for 3 seconds)
- Significant bradycardia (sinus bradycardia persisted at least for 30 seconds with a rate below 50 beats/min)
- High-grade atrioventricular block (2nd-degree Mobitz Type II or 3rd degree)
- Supraventricular tachycardia (sudden onset tachycardia with narrow QRS complexes persisted over 30 seconds)
- Atrial flutter or fibrillation (sustained over 30 seconds)
- Frequent premature ventricular beats (≥30 beats/hour)
- Any ventricular tachycardia (wide QRS complexes)
- Conditions
- Neuromuscular Blockade
- Being tested
- Neostigmine, Sugammadex
- Keywords
- Bradycardia, Cardiac Arrhythmias, Neostigmine, Neuromuscular Blockade, Sugammadex, Train-of-Four Monitoring
- Medical subject headings
- Bradycardia, Arrhythmias, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NeostigmineDrug
50 mcg/kg neostigmine was used under the guidance of TOF monitoring after cessation of anesthesia.
SugammadexDrug
2 mg/kg sugammadex was used under the guidance of TOF monitoring after cessation of anesthesia.
| Study group | Role | What they receive |
|---|---|---|
| Group N | Active comparator | Neostigmine was used for the reversal of neuromuscular blockade. Receives: Drug: Neostigmine |
| Group S | Active comparator | Sugammadex was used for the reversal of neuromuscular blockade. Receives: Drug: Sugammadex |
What is being measured
The primary outcome is the main question the study is designed to answer.
Significant arrhythmic event
Pause (no waves on ECG recording at least for 3 seconds), significant bradycardia (sinus bradycardia persisted at least for 30 seconds with a rate below 50 beats/min), high-grade atrioventricular block (2nd-degree Mobitz Type II or 3rd degree), supraventricular tachycardia (sudden onset tachycardia with narrow QRS complexes persisted over 30 seconds), atrial flutter or fibrillation (sustained over 30 seconds), Frequent premature ventricular beats (≥30 beats/hour).
Measured: Up to 12 hours after surgical procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2021
- Study start1 Jun 2019
- Primary completion1 Oct 2019
- Study completion1 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Neuromuscular BlockadeStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 1:1 randomization
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Başakşehir Çam & Sakura City Hospital
- Sponsor type
- Other government
- Collaborators
- Medipol University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04720573
- Sponsor's protocol ID
- BasaksehirCamSakuraSehirH
- Status last verified
- Jan 2021
- First submitted
- 19 Jan 2021
- Last updated
- 22 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lorentz MN, Vianna BS. Cardiac dysrhythmias and anesthesia. Rev Bras Anestesiol. 2011 Nov-Dec;61(6):798-813. doi: 10.1016/S0034-7094(11)70090-3. English, Multiple languages.
PubMed 22063382Dahl V, Pendeville PE, Hollmann MW, Heier T, Abels EA, Blobner M. Safety and efficacy of sugammadex for the reversal of rocuronium-induced neuromuscular blockade in cardiac patients undergoing noncardiac surgery. Eur J Anaesthesiol. 2009 Oct;26(10):874-84. doi: 10.1097/EJA.0b013e32832c605b.
PubMed 19455040Kizilay D, Dal D, Saracoglu KT, Eti Z, Gogus FY. Comparison of neostigmine and sugammadex for hemodynamic parameters in cardiac patients undergoing noncardiac surgery. J Clin Anesth. 2016 Feb;28:30-5. doi: 10.1016/j.jclinane.2015.08.002. Epub 2015 Nov 11.
PubMed 26796612Staikou C, Stamelos M, Stavroulakis E. Impact of anaesthetic drugs and adjuvants on ECG markers of torsadogenicity. Br J Anaesth. 2014 Feb;112(2):217-30. doi: 10.1093/bja/aet412. Epub 2013 Dec 3.
PubMed 24305646Carron M, Zarantonello F, Tellaroli P, Ori C. Efficacy and safety of sugammadex compared to neostigmine for reversal of neuromuscular blockade: a meta-analysis of randomized controlled trials. J Clin Anesth. 2016 Dec;35:1-12. doi: 10.1016/j.jclinane.2016.06.018. Epub 2016 Aug 4.
PubMed 27871504Hristovska AM, Duch P, Allingstrup M, Afshari A. The comparative efficacy and safety of sugammadex and neostigmine in reversing neuromuscular blockade in adults. A Cochrane systematic review with meta-analysis and trial sequential analysis. Anaesthesia. 2018 May;73(5):631-641. doi: 10.1111/anae.14160. Epub 2017 Dec 27.
PubMed 29280475Yamashita Y, Takasusuki T, Kimura Y, Komatsuzaki M, Yamaguchi S. Effects of Neostigmine and Sugammadex for Reversal of Neuromuscular Blockade on QT Dispersion Under Propofol Anesthesia: A Randomized Controlled Trial. Cardiol Ther. 2018 Dec;7(2):163-172. doi: 10.1007/s40119-018-0119-9. Epub 2018 Sep 14.
PubMed 30218410
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of the Neuromuscular Blockade and Its Reversal on Perioperative Arrhythmias
- ClinicalTrials.gov ID
- NCT04720573
- Acronym / sponsor ID
- BasaksehirCamSakuraSehirH
- Conditions
- Neuromuscular Blockade
- Keywords
- Bradycardia, Cardiac Arrhythmias, Neostigmine, Neuromuscular Blockade, Sugammadex, Train-of-Four Monitoring
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Başakşehir Çam & Sakura City HospitalOther government
- Collaborators
- Medipol University
- Study start
- 1 Jun 2019 (actual)
- Primary completion
- 1 Oct 2019 (actual)
- Study completion
- 1 Nov 2019 (actual)
- First posted
- 22 Jan 2021 (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.
Patients scheduled for elective abdominopelvic laparoscopic surgery under general anesthesia were included. Rocuronium was used for the neuromuscular blockade (NMB) and the level of NMB was monitored with train-of-four (TOF) measurements. The participants from whom informed consent had been received were allocated to two groups according to the agent used for reversal of NMB, sugammadex, or neostigmine. The ECG recordings of the subjects were followed with a rhythm Holter device throughout the procedure until the postoperative 12th hour. Additionally, preoperative and immediate postoperative 12-lead ECGs were evaluated for corrected QT calculations and QT dispersion. Proarrhythmogenicity was assessed with QT related measurements. The documented arrhythmic events on the Holter monitoring were designated as clinical end-points.
Detailed description
Eighty consecutive patients, to whom an elective abdominopelvic surgery under general anesthesia was planned, were included in the study. Participants were allocated to two groups considering the agent to be used for the reversal of neuromuscular blockade by closed-envelope randomization. Neostigmine was used for this purpose in Group N, while sugammadex was used in Group S. Demographic features including hypertension, diabetes mellitus, presence of coronary artery disease, heart failure, and previous arrhythmia were noted. Body mass index was calculated with the Du Bois method. In the operation room, heart rate, blood pressure, body temperature, arterial oxygen saturation, and TOF ratio were recorded. General anesthesia was induced with midazolam, fentanyl, and propofol; and maintained by remifentanil and sevoflurane. In Group N, 50 mcg/kg neostigmine and 20 mcg/kg atropine were used for NMB reversal. In Group S, reversal was achieved by the administration of sugammadex at a dose of 2 mg/kg. QT interval was measured in leads DII or V5 and adjusted to the heart rate by the Bazzett formula. QTc values at the baseline and postoperative ECGs were recorded and presented with milliseconds. An increase of over 60 ms in QTc interval or a postoperative measurement over 500 ms were assumed to be distinctly abnormal. QT dispersion was calculated by extracting the minimum QT length from the maximum QT length in 12-lead ECG. In rhythm holter monitoring, minimum and mean heart rates and specific arrhythmic events were recorded. In the heart rate variability analysis, the standard deviation of the interbeat intervals of normal sinus beats (SDNN) and the root mean square of successive differences between normal heartbeats (rMSSD) were calculated. The following events were designated as clinical end-points.
- Pause (no waves on ECG recording at least for 3 seconds)
- Significant bradycardia (sinus bradycardia persisted at least for 30 seconds with a rate below 50 beats/min)
- High-grade atrioventricular block (2nd-degree Mobitz Type II or 3rd degree)
- Supraventricular tachycardia (sudden onset tachycardia with narrow QRS complexes persisted over 30 seconds)
- Atrial flutter or fibrillation (sustained over 30 seconds)
- Frequent premature ventricular beats (≥30 beats/hour)
- Any ventricular tachycardia (wide QRS complexes)
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- 1:1 randomization
| Arm | Type | Receives |
|---|---|---|
| Group N | Active comparator | Drug: NeostigmineNeostigmine was used for the reversal of neuromuscular blockade. |
| Group S | Active comparator | Drug: SugammadexSugammadex was used for the reversal of neuromuscular blockade. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Planned abdominopelvic surgery under general anesthesia
- ASA II-IV
- Willing to give consent
Key exclusion criteria (6 listed)
- Significantly impaired left ventricular systolic function (ejection fraction < 40%)
- Significant ongoing arrhythmia (sinus bradycardia with a heart rate below 40 beats/min, Mobitz Type II or 3rd-grade atrioventricular block, persistent or permanent atrial flutter or fibrillation, bigeminal or trigeminal ventricular premature beats, documented ventricular tachycardia)
- Severely reduced renal function (glomerular filtration rate < 30 ml/min/1.73 m2)
- Severe respiratory diseases, neuromuscular disorders, and known allergy to anesthetic agents or adjuvants
- Pregnancy and breastfeeding
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 |
|---|---|---|
| Neostigmine50 mcg/kg neostigmine was used under the guidance of TOF monitoring after cessation of anesthesia. | Drug | Group N |
| Sugammadex2 mg/kg sugammadex was used under the guidance of TOF monitoring after cessation of anesthesia. | Drug | Group S |
Primary outcome
Significant arrhythmic event
Time frame: Up to 12 hours after surgical procedure
Pause (no waves on ECG recording at least for 3 seconds), significant bradycardia (sinus bradycardia persisted at least for 30 seconds with a rate below 50 beats/min), high-grade atrioventricular block (2nd-degree Mobitz Type II or 3rd degree), supraventricular tachycardia (sudden onset tachycardia with narrow QRS complexes persisted over 30 seconds), atrial flutter or fibrillation (sustained over 30 seconds), Frequent premature ventricular beats (≥30 beats/hour).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2021.
- Background: PubMed 22063382Lorentz MN, Vianna BS. Cardiac dysrhythmias and anesthesia. Rev Bras Anestesiol. 2011 Nov-Dec;61(6):798-813. doi: 10.1016/S0034-7094(11)70090-3. English, Multiple languages.
- Background: PubMed 19455040Dahl V, Pendeville PE, Hollmann MW, Heier T, Abels EA, Blobner M. Safety and efficacy of sugammadex for the reversal of rocuronium-induced neuromuscular blockade in cardiac patients undergoing noncardiac surgery. Eur J Anaesthesiol. 2009 Oct;26(10):874-84. doi: 10.1097/EJA.0b013e32832c605b.
- Background: PubMed 26796612Kizilay D, Dal D, Saracoglu KT, Eti Z, Gogus FY. Comparison of neostigmine and sugammadex for hemodynamic parameters in cardiac patients undergoing noncardiac surgery. J Clin Anesth. 2016 Feb;28:30-5. doi: 10.1016/j.jclinane.2015.08.002. Epub 2015 Nov 11.
- Results publication: PubMed 24305646Staikou C, Stamelos M, Stavroulakis E. Impact of anaesthetic drugs and adjuvants on ECG markers of torsadogenicity. Br J Anaesth. 2014 Feb;112(2):217-30. doi: 10.1093/bja/aet412. Epub 2013 Dec 3.
- Results publication: PubMed 27871504Carron M, Zarantonello F, Tellaroli P, Ori C. Efficacy and safety of sugammadex compared to neostigmine for reversal of neuromuscular blockade: a meta-analysis of randomized controlled trials. J Clin Anesth. 2016 Dec;35:1-12. doi: 10.1016/j.jclinane.2016.06.018. Epub 2016 Aug 4.
- Results publication: PubMed 29280475Hristovska AM, Duch P, Allingstrup M, Afshari A. The comparative efficacy and safety of sugammadex and neostigmine in reversing neuromuscular blockade in adults. A Cochrane systematic review with meta-analysis and trial sequential analysis. Anaesthesia. 2018 May;73(5):631-641. doi: 10.1111/anae.14160. Epub 2017 Dec 27.
- Results publication: PubMed 30218410Yamashita Y, Takasusuki T, Kimura Y, Komatsuzaki M, Yamaguchi S. Effects of Neostigmine and Sugammadex for Reversal of Neuromuscular Blockade on QT Dispersion Under Propofol Anesthesia: A Randomized Controlled Trial. Cardiol Ther. 2018 Dec;7(2):163-172. doi: 10.1007/s40119-018-0119-9. Epub 2018 Sep 14.
- Sugammadex briefing documentLink provided by the sponsor.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neostigmine and Sugammadex in people with Neuromuscular Blockade, run by Başakşehir Çam & Sakura City Hospital 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 6 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 22 Jan 2021. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Significant arrhythmic event (time frame: Up to 12 hours after surgical procedure). 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 NCT04720573, which also lists 7 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 22 Jan 2021.