Postoperative Residual CurarizationPhase 4NCT03460509
Reversal With Low Doses of Sugammadex in Patients Undergoing Non-cardiac Surgery
A Phase 4 study testing Sugammadex in people with Postoperative Residual Curarization and Neuromuscular Block, run by The Hospital of Vestfold.
Trial summary
Neuromuscular blocking agents (NMBA) are among the most commonly used drugs during general anesthesia and may induce complete muscle paralysis.They are used clinically to facilitate endotracheal intubation and to optimize surgical working conditions. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Postoperative Residual Curarization, Neuromuscular Block
- What is being tested?
- Sugammadex
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 144 participants
- Where
- No sites listed yet
- Study dates
- Aug 2018to Dec 2019
- Phase
- Phase 4
- 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 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient, both genders, undergoing any elective in-hospital surgical procedure under general anesthesia requiring rocuronium neuromuscular block.
- ASA I-IV
- Signed informed consent
Who cannot join
- Patient less than 18 years of age
- Patient participating in another clinical study which could interfere with TOF trial.
- Patient with neuromuscular disease
- Patient from ICU
- BMI > 30.0 kg/m2
- Patient scheduled for local or regional anesthesia only
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- Patient undergoing general anesthesia without rocuronium
- Patient with hypersensitivity to NMBAs or sugammadex. Also hypersensitivity to any active substance or to any of the following excipient: Hydrochloric acid 3.7% (to adjust pH) and/or sodium hydroxide (to adjust pH) Water for injections .
- Renal dysfunction (GFR<30 mL/min/1,73m2)
- Hepatic dysfunction
- Patient who have received sugammadex in the last 24 h.
- Pregnant or breastfeeding woman. Women in childbearing age must have a negative pregnant test before inclusion.
- Bradycardia (puls <40)
- Hypotension (Systolic BP <90 mmHg)
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Randomized Double Blind Trial Comparing Reversal With Low Doses Of Sugammadex aFter Rocuronium-induced Neuromuscular Block Under General Anesthesia in Patients Undergoing Non-cardiac Surgery(TOF TRIAL)
Neuromuscular blocking agents (NMBA) are among the most commonly used drugs during general anesthesia and may induce complete muscle paralysis.They are used clinically to facilitate endotracheal intubation and to optimize surgical working conditions. Incomplete recovery from non-depolarising NMBAs continues to be a common problem in modern postoperative care unit and is associated with significant risk of microaspiration and hypoventilation which leads to pulmonary complications.Recently effective reversal of neuromuscular blockade has been described by use of lower dose of sugammadex the recommended without providing adequate answer to whether the lower dose is safe enough to avoid recurrent block.
Hypotheses:
Read more
- Administration of sugammadex 0.25 mg/kg at TOF ratio 0.3 will successfully reverse (TOF=0.9) rocuronium induced neuromuscular block within 10 min.
- Recurrent block (TOF ratio < 0.9) does not occur after reversal with low dose sugammadex 0.25 mg/kg.
The primary objective of this trial is to assess the dose-response characteristics of sugammadex in reversing rocuronium induced neuromuscular block and to identify the minimal effective dose
Secondary objective is to assess the safety of different doses of sugammadex (recurrent block (TOF ratio < 0.9) after reversal and the occurrence of adverse reactions)
Sugammadex is a very expensive drug which limits its use i anaesthesia department. By optimising drug dosage it may have economic impact and contribute to a wider use of sugammadex to reverse neuromuscular block before extubation and thus avoid incomplete recovery. This may lead to less risk for postoperative pulmonary complications and thereby reduce morbidity and mortality after surgery.
Read the detailed description
Doses of study drug will be 0 mg/kg Ideal Body Weight (IBW), 0.25 mg/kg IBW, 0.50 mg/kg IBW, 1.0 mg/kg IBW and 2.0 mg/kg IBW. TOF will be measured every 10th second until full reversal.
- Being tested
- Sugammadex
- Medical subject headings
- Delayed Emergence from Anesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SugammadexDrug
Dose-response
| Study group | Role | What they receive |
|---|---|---|
| Sugammadex 0 mg/kg | Placebo comparator | Placebo NaCl 0,9% Receives: Drug: Sugammadex |
| Sugammadex 0,25 mg/kg | Active comparator | Sugammadex 0.25 mg/kg IBW Receives: Drug: Sugammadex |
| Sugammadex 0,5 mg/kg | Active comparator | Sugammadex 0.50 mg/kg IBW Receives: Drug: Sugammadex |
| Sugammadex 1mg/kg | Active comparator | Sugammadex 1.0 mg/kg IBW Receives: Drug: Sugammadex |
| Sugammadex 2mg/kg | Active comparator | Sugammadex 2 mg/kg IBW Receives: Drug: Sugammadex |
What is being measured
The primary outcome is the main question the study is designed to answer.
The time from study drug administration to reaching a TOF ratio of 0.9.
Measured: 10 minutes
Secondary outcomes (2)
Number of patient with reoccurrence of neuromuscular block after initial reversal to TOF ratio 0.9.
Measured: 20 minutes
Number of patients with adverse reactions in each group
Adverse reactions (anaphylactic reaction, flushing, urticaria, erythematous rash, (severe) hypotension (BPsyst> 75 mmHg), tachycardia (heart rate> 120 beats/min), bradycardia (heart rate <40 beats/min), swelling of tongue, swelling of pharynx, bronchospasm)
Measured: until discharge - 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2018
- Study startAug 2018 (estimated)
- Primary completionDec 2019 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative Residual CurarizationStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 144 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Hospital of Vestfold
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tayyba Aslam, The Hospital of Vestfold
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03460509
- Sponsor's protocol ID
- SIVAA01
- Status last verified
- May 2018
- First submitted
- 17 Oct 2017
- Last updated
- 30 May 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Double Blind Trial Comparing Reversal With Low Doses Of Sugammadex aFter Rocuronium-induced Neuromuscular Block Under General Anesthesia in Patients Undergoing Non-cardiac Surgery(TOF TRIAL)
- ClinicalTrials.gov ID
- NCT03460509
- Acronym / sponsor ID
- SIVAA01
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 144 participants (estimated)
- Lead sponsor
- The Hospital of VestfoldUniversity, hospital or other
- Study start
- Aug 2018 (estimated)
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 9 Mar 2018 (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.
Neuromuscular blocking agents (NMBA) are among the most commonly used drugs during general anesthesia and may induce complete muscle paralysis.They are used clinically to facilitate endotracheal intubation and to optimize surgical working conditions. Incomplete recovery from non-depolarising NMBAs continues to be a common problem in modern postoperative care unit and is associated with significant risk of microaspiration and hypoventilation which leads to pulmonary complications.Recently effective reversal of neuromuscular blockade has been described by use of lower dose of sugammadex the recommended without providing adequate answer to whether the lower dose is safe enough to avoid recurrent block.
Hypotheses:
- Administration of sugammadex 0.25 mg/kg at TOF ratio 0.3 will successfully reverse (TOF=0.9) rocuronium induced neuromuscular block within 10 min.
- Recurrent block (TOF ratio < 0.9) does not occur after reversal with low dose sugammadex 0.25 mg/kg.
The primary objective of this trial is to assess the dose-response characteristics of sugammadex in reversing rocuronium induced neuromuscular block and to identify the minimal effective dose
Secondary objective is to assess the safety of different doses of sugammadex (recurrent block (TOF ratio < 0.9) after reversal and the occurrence of adverse reactions)
Sugammadex is a very expensive drug which limits its use i anaesthesia department. By optimising drug dosage it may have economic impact and contribute to a wider use of sugammadex to reverse neuromuscular block before extubation and thus avoid incomplete recovery. This may lead to less risk for postoperative pulmonary complications and thereby reduce morbidity and mortality after surgery.
Detailed description
Doses of study drug will be 0 mg/kg Ideal Body Weight (IBW), 0.25 mg/kg IBW, 0.50 mg/kg IBW, 1.0 mg/kg IBW and 2.0 mg/kg IBW. TOF will be measured every 10th second until full reversal.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Sugammadex 0 mg/kg | Placebo comparator | Drug: SugammadexPlacebo NaCl 0,9% |
| Sugammadex 0,25 mg/kg | Active comparator | Drug: SugammadexSugammadex 0.25 mg/kg IBW |
| Sugammadex 0,5 mg/kg | Active comparator | Drug: SugammadexSugammadex 0.50 mg/kg IBW |
| Sugammadex 1mg/kg | Active comparator | Drug: SugammadexSugammadex 1.0 mg/kg IBW |
| Sugammadex 2mg/kg | Active comparator | Drug: SugammadexSugammadex 2 mg/kg IBW |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patient, both genders, undergoing any elective in-hospital surgical procedure under general anesthesia requiring rocuronium neuromuscular block.
- ASA I-IV
- Signed informed consent
Key exclusion criteria (14 listed)
- Patient less than 18 years of age
- Patient participating in another clinical study which could interfere with TOF trial.
- Patient with neuromuscular disease
- Patient from ICU
- BMI > 30.0 kg/m2
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 |
|---|---|---|
| SugammadexDose-response | Drug | Sugammadex 0 mg/kg, Sugammadex 0,25 mg/kg, Sugammadex 0,5 mg/kg, Sugammadex 1mg/kg, Sugammadex 2mg/kg |
Primary outcome
The time from study drug administration to reaching a TOF ratio of 0.9.
Time frame: 10 minutes
2 secondary outcomes
Number of patient with reoccurrence of neuromuscular block after initial reversal to TOF ratio 0.9.
Time frame: 20 minutes
Number of patients with adverse reactions in each group
Time frame: until discharge - 3 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2018.
- 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.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Sugammadex in people with Postoperative Residual Curarization and Neuromuscular Block, run by The Hospital of Vestfold.
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 14 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 30 May 2018. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tayyba Aslam, MD (004798097489, tayybaaslam@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The time from study drug administration to reaching a TOF ratio of 0.9. (time frame: 10 minutes). 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 30 May 2018.