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Different Reversal Agents 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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Post-operative Residual Curarization | Drug: Sugammadex Injection [Bridion] Drug: Neostigmine | Phase 4 |
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 Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 80 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Triple (Participant, Care Provider, Outcomes Assessor) |
| Primary Purpose: | Prevention |
| Official Title: | Sugammadex Versus Neostigmine in Pediatric Day-case Cancer Surgery |
| Estimated Study Start Date : | June 2019 |
| Estimated Primary Completion Date : | September 2019 |
| Estimated Study Completion Date : | October 2019 |
| Arm | Intervention/treatment |
|---|---|
|
Experimental: Group S
Sugammadex for reversal of steroidal neuromuscular blockers, intravenous injection ,2mg/kg
|
Drug: Sugammadex Injection [Bridion]
Reversal of neuromuscular blockers
|
|
Active Comparator: Group N
Reversal of neuromuscular blockers, iv injection, 0.05 mg/kg
|
Drug: Neostigmine
Reversal of neuromuscular blockers
|
- 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%
- 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 ]time from neuromuscular blocker administration to extubation
| Ages Eligible for Study: | 2 Years to 18 Years (Child, Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Age ≥2 years and < 18 years.
- American society of anesthesiologists (ASA) status 1-3.
- patients undergoing outpatient procedures
Exclusion Criteria:
- Known drug hypersensitivity.-
- History of renal or hepatic failure.
- Diseases of the neuromuscular junction.
- history of malignant hyperthermia.
| Contact: Amani Ga Mohamed, MSc | (202)01119611061 | amanigabr@yahoo.com |
| Study Director: | Mohamed MO Hegazy, MD | Cairo University | |
| Study Director: | Mohamed Ad Elramly, MD | Cairo University |
| Tracking Information | |||||||
|---|---|---|---|---|---|---|---|
| First Submitted Date ICMJE | June 18, 2019 | ||||||
| First Posted Date ICMJE | June 25, 2019 | ||||||
| Last Update Posted Date | June 25, 2019 | ||||||
| Estimated Study Start Date ICMJE | June 2019 | ||||||
| Estimated Primary Completion Date | September 2019 (Final data collection date for primary outcome measure) | ||||||
| Current Primary Outcome Measures ICMJE |
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%
|
||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||
| Change History | No Changes Posted | ||||||
| Current Secondary Outcome Measures ICMJE |
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 ] time from neuromuscular blocker administration to extubation
|
||||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||
| Descriptive Information | |||||||
| Brief Title ICMJE | Different Reversal Agents in Pediatric Day-case Cancer Surgery | ||||||
| Official Title ICMJE | Sugammadex Versus Neostigmine in Pediatric Day-case Cancer Surgery | ||||||
| Brief 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. |
||||||
| 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 Type ICMJE | Interventional | ||||||
| Study Phase ICMJE | Phase 4 | ||||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Triple (Participant, Care Provider, Outcomes Assessor) Primary Purpose: Prevention |
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| Condition ICMJE | Post-operative Residual Curarization | ||||||
| Intervention ICMJE |
|
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| Study Arms ICMJE |
|
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| Publications * |
|
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|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||
| Recruitment Status ICMJE | Unknown status | ||||||
| Estimated Enrollment ICMJE |
80 | ||||||
| Original Estimated Enrollment ICMJE | Same as current | ||||||
| Estimated Study Completion Date ICMJE | October 2019 | ||||||
| Estimated Primary Completion Date | September 2019 (Final data collection date for primary outcome measure) | ||||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
|
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| Sex/Gender ICMJE |
|
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| Ages ICMJE | 2 Years to 18 Years (Child, Adult) | ||||||
| Accepts Healthy Volunteers ICMJE | No | ||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||
| Listed Location Countries ICMJE | Not Provided | ||||||
| Removed Location Countries | |||||||
| Administrative Information | |||||||
| NCT Number ICMJE | NCT03996655 | ||||||
| Other Study ID Numbers ICMJE | Reversal agents in pediatrics | ||||||
| Has Data Monitoring Committee | Not Provided | ||||||
| U.S. FDA-regulated Product |
|
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| IPD Sharing Statement ICMJE | Not Provided | ||||||
| Responsible Party | Amani Gaber Mohamed,MSc, National Cancer Institute, Egypt | ||||||
| Study Sponsor ICMJE | National Cancer Institute, Egypt | ||||||
| Collaborators ICMJE | Not Provided | ||||||
| Investigators ICMJE |
|
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| PRS Account | National Cancer Institute, Egypt | ||||||
| Verification Date | June 2019 | ||||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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