Post-operative Residual CurarizationPhase 4NCT03996655
Different Reversal Agents in Pediatric Day-case Cancer Surgery
A Phase 4 study testing Sugammadex Injection [Bridion] and Neostigmine in people with Post-operative Residual Curarization, run by National Cancer Institute, Egypt.
Trial summary
The aim of this study was to compare the efficacy of sugammadex and neostigmine on reversing neuromuscular blockers in pediatric patients undergoing outpatient surgical procedures. Read more about this study
- Who is it for?
- Ages 2 to 18 years
- Conditions the study is for
- Post-operative Residual Curarization
- What is being tested?
- Sugammadex Injection [Bridion] and Neostigmine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- Jun 2019to Oct 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 2 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age ≥2 years and < 18 years.
- American society of anesthesiologists (ASA) status 1-3.
- patients undergoing outpatient procedures
Who cannot join
- Known drug hypersensitivity.-
- History of renal or hepatic failure.
- Diseases of the neuromuscular junction.
- history of malignant hyperthermia.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Sugammadex Versus Neostigmine in Pediatric Day-case Cancer Surgery
The aim of this study was to compare the efficacy of sugammadex and neostigmine on
reversing neuromuscular blockers in pediatric patients undergoing outpatient surgical
procedures.
Read the detailed description
Postoperative residual curarization (PORC)" a residual duration of action of muscle relaxants beyond the end of the operation" in postoperative patients is a succession of the presence of blocked nicotinic receptors. Even in observationally asymptomatic patients, 60-70% of these receptors can be still blocked. PORC can cause delayed recovery, hypoxia, metabolic derangement and rarely death. Cholinesterase inhibitors are traditionally used for reversal of neuromuscular blockade (NMB). Among these agents neostigmine is the most potent and selective one. Cholinesterase inhibitors have multisystemic side effects. Since these agents are not selective to nicotinic receptors and also stimulate the muscarinic system, there can be quite a few serious adverse effects as follows: Bradycardia, QT lengthening, bronchoconstriction, hypersalivation and increased motility. To avoid these effects, concomitant anticholinergic agents, such as atropine or glycopyrolate, are administered to the patient. The incidence of PORC is still high with the prevalence of a train-of-four (TOF) ratio of less than 0.9 found in the postoperative recovery unit. Recent studies have been able to link even low levels of residual paralysis (TOF ratio <0.9) with significant impairment of pharyngeal muscle function, hypoxic ventilatory drive and decreased respiratory function in the immediate postoperative period.
Despite the knowledge of such side effects, and despite the introduction of various new neuromuscular blocking agents (NMBA) such as rocuronium or mivacurium over the last 15 years, no significant reduction in the incidence of residual neuromuscular blockade has so far been observable.
Today, sugammadex is an alternative to the decurarization procedure, which was traditionally executed with cholinesterase inhibitors. Sugammadex a γ-cyclodextrin with a high affinity to rocuronium and other aminosteroidal NMBA that allows the rapid and complete reversal of especially rocuronium-induced neuromuscular blockade, has raised hopes to overcome the problem of residual neuromuscular blockade. Sugammadex is proved to be a safe and superior agent in NMB reversal compared to neostigmine in adults.
PORC and the muscarinic side effects are not anticipated when using sugammadex,.
Also, due to its pharmacodynamic profile, sugammadex, in combination with rocuronium, have the potential to displace succinylcholine as the "gold standard" muscle relaxant for rapid sequence induction.
The rudimentary neuromuscular junction, the variability of fibrin fibers, the differences in drug distribution and body volume in children change their neuromuscular conduction. These factors can cause prolonged recovery and increased risk of PORC. However, there is few studies in the literature concerning sugammadex administration in pediatric patients.
- Conditions
- Post-operative Residual Curarization
- Being tested
- Sugammadex Injection [Bridion], Neostigmine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sugammadex Injection [Bridion]Drug
Reversal of neuromuscular blockers
NeostigmineDrug
Reversal of neuromuscular blockers
| Study group | Role | What they receive |
|---|---|---|
| Group S | Experimental | Sugammadex for reversal of steroidal neuromuscular blockers, intravenous injection ,2mg/kg Receives: Drug: Sugammadex Injection [Bridion] |
| Group N | Active comparator | Reversal of neuromuscular blockers, iv injection, 0.05 mg/kg Receives: Drug: Neostigmine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recovery time
time from neostigmine or sugammadex administration until recovery of the TOF ratio to 0.9%
Measured: time from reversal administration until TOF ratio reaches0.9%, ranging from 1 to 2.5 minutes, measured withThe train-of-four (TOF) equipment working with the nerve-muscle acceleromyometry principle (TOF Draeger Medical Systems, Inc.16 Electronic Avenue,
Secondary outcomes (1)
extubation time
time from neuromuscular blocker administration to extubation
Measured: time from muscle relaxant administration until extubation,extubation will be performed based on clinical criteria extubation timeis estimated to range from 50 to 55 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2019
- Study startJun 2019 (estimated)
- Primary completionSep 2019 (estimated)
- Study completionOct 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Post-operative 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute, Egypt
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amani Gaber Mohamed,MSc, National Cancer Institute, Egypt
- Investigators
- Mohamed MO Hegazy, MD, Study director, Cairo UniversityMohamed Ad Elramly, MD, Study director, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03996655
- Sponsor's protocol ID
- Reversal agents in pediatrics
- Status last verified
- Jun 2019
- First submitted
- 18 Jun 2019
- Last updated
- 25 Jun 2019
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Ammar AS, Mahmoud KM, Kasemy ZA. A comparison of sugammadex and neostigmine for reversal of rocuronium-induced neuromuscular blockade in children. Acta Anaesthesiol Scand. 2017 Apr;61(4):374-380. doi: 10.1111/aas.12868. Epub 2017 Feb 10.
PubMed 28185260Meretoja OA. Neuromuscular block and current treatment strategies for its reversal in children. Paediatr Anaesth. 2010 Jul;20(7):591-604. doi: 10.1111/j.1460-9592.2010.03335.x.
PubMed 20642658
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sugammadex Versus Neostigmine in Pediatric Day-case Cancer Surgery
- ClinicalTrials.gov ID
- NCT03996655
- Acronym / sponsor ID
- Reversal agents in pediatrics
- Conditions
- Post-operative Residual Curarization
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- National Cancer Institute, EgyptUniversity, hospital or other
- Study start
- Jun 2019 (estimated)
- Primary completion
- Sep 2019 (estimated)
- Study completion
- Oct 2019 (estimated)
- First posted
- 25 Jun 2019 (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.
The aim of this study was to compare the efficacy of sugammadex and neostigmine on
reversing neuromuscular blockers in pediatric patients undergoing outpatient surgical
procedures.
Detailed description
Postoperative residual curarization (PORC)" a residual duration of action of muscle relaxants beyond the end of the operation" in postoperative patients is a succession of the presence of blocked nicotinic receptors. Even in observationally asymptomatic patients, 60-70% of these receptors can be still blocked. PORC can cause delayed recovery, hypoxia, metabolic derangement and rarely death. Cholinesterase inhibitors are traditionally used for reversal of neuromuscular blockade (NMB). Among these agents neostigmine is the most potent and selective one. Cholinesterase inhibitors have multisystemic side effects. Since these agents are not selective to nicotinic receptors and also stimulate the muscarinic system, there can be quite a few serious adverse effects as follows: Bradycardia, QT lengthening, bronchoconstriction, hypersalivation and increased motility. To avoid these effects, concomitant anticholinergic agents, such as atropine or glycopyrolate, are administered to the patient. The incidence of PORC is still high with the prevalence of a train-of-four (TOF) ratio of less than 0.9 found in the postoperative recovery unit. Recent studies have been able to link even low levels of residual paralysis (TOF ratio <0.9) with significant impairment of pharyngeal muscle function, hypoxic ventilatory drive and decreased respiratory function in the immediate postoperative period.
Despite the knowledge of such side effects, and despite the introduction of various new neuromuscular blocking agents (NMBA) such as rocuronium or mivacurium over the last 15 years, no significant reduction in the incidence of residual neuromuscular blockade has so far been observable.
Today, sugammadex is an alternative to the decurarization procedure, which was traditionally executed with cholinesterase inhibitors. Sugammadex a γ-cyclodextrin with a high affinity to rocuronium and other aminosteroidal NMBA that allows the rapid and complete reversal of especially rocuronium-induced neuromuscular blockade, has raised hopes to overcome the problem of residual neuromuscular blockade. Sugammadex is proved to be a safe and superior agent in NMB reversal compared to neostigmine in adults.
PORC and the muscarinic side effects are not anticipated when using sugammadex,.
Also, due to its pharmacodynamic profile, sugammadex, in combination with rocuronium, have the potential to displace succinylcholine as the "gold standard" muscle relaxant for rapid sequence induction.
The rudimentary neuromuscular junction, the variability of fibrin fibers, the differences in drug distribution and body volume in children change their neuromuscular conduction. These factors can cause prolonged recovery and increased risk of PORC. However, there is few studies in the literature concerning sugammadex administration in pediatric patients.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group S | Experimental | Drug: Sugammadex Injection [Bridion]Sugammadex for reversal of steroidal neuromuscular blockers, intravenous injection ,2mg/kg |
| Group N | Active comparator | Drug: NeostigmineReversal of neuromuscular blockers, iv injection, 0.05 mg/kg |
Who may qualify
- Ages
- 2 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Age ≥2 years and < 18 years.
- American society of anesthesiologists (ASA) status 1-3.
- patients undergoing outpatient procedures
Key exclusion criteria (4 listed)
- Known drug hypersensitivity.-
- History of renal or hepatic failure.
- Diseases of the neuromuscular junction.
- history of malignant hyperthermia.
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 |
|---|---|---|
| Sugammadex Injection [Bridion]Reversal of neuromuscular blockers | Drug | Group S |
| NeostigmineReversal of neuromuscular blockers | Drug | Group N |
Primary outcome
Recovery time
Time frame: time from reversal administration until TOF ratio reaches0.9%, ranging from 1 to 2.5 minutes, measured withThe train-of-four (TOF) equipment working with the nerve-muscle acceleromyometry principle (TOF Draeger Medical Systems, Inc.16 Electronic Avenue,
time from neostigmine or sugammadex administration until recovery of the TOF ratio to 0.9%
1 secondary outcome
extubation time
Time frame: time from muscle relaxant administration until extubation,extubation will be performed based on clinical criteria extubation timeis estimated to range from 50 to 55 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2019.
- Background: PubMed 28185260Ammar AS, Mahmoud KM, Kasemy ZA. A comparison of sugammadex and neostigmine for reversal of rocuronium-induced neuromuscular blockade in children. Acta Anaesthesiol Scand. 2017 Apr;61(4):374-380. doi: 10.1111/aas.12868. Epub 2017 Feb 10.
- Background: PubMed 20642658Meretoja OA. Neuromuscular block and current treatment strategies for its reversal in children. Paediatr Anaesth. 2010 Jul;20(7):591-604. doi: 10.1111/j.1460-9592.2010.03335.x.
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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.
Mohamed MO Hegazy, MD study director
Cairo University
Mohamed Ad Elramly, MD study director
Cairo University
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Sugammadex Injection [Bridion] and Neostigmine in people with Post-operative Residual Curarization, run by National Cancer Institute, Egypt.
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 4 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 25 Jun 2019. 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.
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 Amani Ga Mohamed, MSc ((202)01119611061, amanigabr@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recovery time (time frame: time from reversal administration until TOF ratio reaches0.9%, ranging from 1 to 2.5 minutes, measured withThe train-of-four (TOF) equipment working with the nerve-muscle acceleromyometry principle (TOF Draeger Medical Systems, Inc.16 Electronic Avenue,). 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 NCT03996655, which also lists 2 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 25 Jun 2019.