Status Approved
First Submitted Date
2018/10/11
Registered Date
2018/11/16
Last Updated Date
2020/12/17
CRIS Required
WHO ICTRP (International Clinical Trial Registry Platform) Required
1. Background
CRIS Registration Number |
KCT0003356 |
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Unique Protocol ID | HPIRB 2018-08-005-001 |
Public/Brief Title | The timing of sugammadex administration |
Scientific Title | Relationship between timing of sugammadex administration and the upper airway obstruction during awakening from anesthesia – A retrospective study |
Acronym | |
MFDS Regulated Study | No |
IND/IDE Protocol | No |
Registered at Other Registry | No |
Healthcare Benefit Approval Status | Not applicable |
2. Institutional Review Board / Ethics Committee
Board Approval Status | Submitted approval |
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Board Approval Number | HPIRB 2018-08-005-001 |
Approval Date | 2018-09-27 |
Institutional Review Board Name | Institutional review board of Haeundae Paik hospital, Inje University |
Institutional Review Board Address | 875, Haeun-daero, Haeundae-gu, Busan |
Institutional Review Board Telephone | 051-797-2747 |
Data Monitoring Committee |
3. Contact Details
Contact Person for Principal Investigator / Scientific Queries | |
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Name | Myoung Jin Ko |
Title | Dr. |
Telephone | +82-51-797-0423 |
Affiliation | Inje University Haeundae Paik Hospital |
Address | Haeundaero 875, Haeundae-gu, Busan, South Korea |
Contact Person for Public Queries | |
Name | Myoung Jin Ko |
Title | Dr. |
Telephone | +82-51-797-0423 |
Affiliation | Inje University Haeundae Paik Hospital |
Address | Haeundaero 875, Haeundae-gu, Busan, South Korea |
Contact Person for Updating Information | |
Name | Myoung Jin Ko |
Title | Dr. |
Telephone | +82-51-797-0423 |
Affiliation | Inje University Haeundae Paik Hospital |
Address | Haeundaero 875, Haeundae-gu, Busan, South Korea |
4. Status
Study Site | Single | |
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Overall Recruitment Status | Recruiting | |
Date of First Enrollment | 2018-10-11 Actual | |
Target Number of Participant | 3391 | |
Primary Completion Date | ||
Study Completion Date | ||
Recruitment Status by Participating Study Site 1 | ||
Name of Study | Inje University Haeundae Paik Hospital | |
Recruitment Status | Recruiting | |
Date of First Enrollment | 2018-10-11 , |
5. Source of Monetary / Material Support
1. Source of Monetary/Material Support | |
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Organization Name | Inje University Haeundae Paik Hospital |
Organization Type | Medical Institute |
Project ID | HPIRB2018-08-005-001 |
6. Sponsor Organization
1. Sponsor Organization | |
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Organization Name | Inje University Haeundae Paik Hospital |
Organization Type | Medical Institute |
7. Study Summary
Lay Summary | An optimal time is important for medication administration. Onset of the medication and interaction with other drugs should be considered to maximize the therapeutic effects and minimize adverse effects. The medications for reversal of muscle relaxants after general anesthesia have such an optimal time. For example, pyridostigmine or neostigmine should be administered when train of four (TOF) count is equal to or greater than 2, or the sign of spontaneous ventilation is present. These drugs are anticholinesterases that inhibit hydrolysis of acetylcholine and allow more acetylcholine available at synapses of neuromuscular junction to compete with the nondepolarizing agents and decrease the neuromuscular blockade. Administration of reversal agents once evidence of spontaneous recovery or 2 or more twitches of the train-of-four (TOF) stimulation is present has a strong correlation with therapeutic durations of the reversal agents. As the muscle relaxants used for general anesthesia have longer therapeutic durations than anticholinesterases, reversal agents should be given in presence of 2nd twitch of TOF to avoid recurarization caused by the residual neuromuscular blocking agents of which duration lasts longer than that of the anticholinesterase drugs. In contrast, sugammadex can be given even if there is no response to TOF stimulation. Sugammadex is a modified γ-cyclodextrin and the selective relaxant–binding agent to inactivate the specific non-depolarizing neuromuscular blocking agents. A medium dose (4 mg/kg) of intravenous sugammadex is recommended during deep block (two or more responses to PTC), and a low dose (2 mg/kg) for moderate block (two or more responses to TOF stimulation). In most patients, all levels of neuromuscular block are reversed within 2 to 3 minutes. However, the effect of different administration timing on the emergence has not been studied in association with anesthetic depth. Rapid reversal of rocuronium-induced neuromuscular blockade may affect the emergence depending on the residual volatile anesthetics and the aim of this study is to find the appropriate timing of sugammadex administration. Study design The effect of different timings of sugammadex administration on emergence reactions was analyzed in all the patients who had surgery under general anesthesia at Haeundae Paik Hospital between October 2017 and July 2018 and received intravenous sugammadex to reverse rocuronium-induced neuromuscular blockade. All electronic medical records were reviewed retrospectively except those of the excluded patients, including preoperative evaluations, anesthesia records, records at PACU and nursing information surveys, in order to collect data on end-tidal volatile anesthetic concentrations, Bispectral Index (BIS) and Minimal alveolar concentration (MAC) at the time of sugammadex administration. Durations in minutes between the discontinuation of anesthetics and the sugammadex administration, time to extubate, time to exit the operating room, the incidence of complications after extubation (upper airway obstruction, vocal cord spasm, hypoxia, hypoventilation, severed cough or other events), and RASS at extubation were also collected to investigate how different timing of sugammadex administration affected the emergence reactions. |
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8. Study Design
Study Type | Observational Study |
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Observational Study Model | Others |
Time Perspective | Retrospective |
Target Number of Participant | 3391 |
Cohort/Group Number | 1 |
Cohort/ Group 1 |
Cohort/Group Label Sugammadex group |
Cohort/Group Description The effect of different timings of sugammadex administration on emergence reactions was analyzed in all the patients who had surgery under general anesthesia at Haeundae Paik Hospital between October 2017 and July 2018 and received intravenous sugammadex to reverse rocuronium-induced neuromuscular blockade. All electronic medical records were reviewed retrospectively except those of the excluded patients, including preoperative evaluations, anesthesia records, records at PACU and nursing information surveys, in order to collect data on end-tidal volatile anesthetic concentrations, Bispectral Index (BIS) and Minimal alveolar concentration (MAC) at the time of sugammadex administration. Durations in minutes between the discontinuation of anesthetics and the sugammadex administration, time to extubate, time to exit the operating room, the incidence of complications after extubation (upper airway obstruction, vocal cord spasm, hypoxia, hypoventilation, severed cough or other events), and RASS at extubation were also collected to investigate how different timing of sugammadex administration affected the emergence reactions. |
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Biospecimen Collection & Archiving |
Not collect nor Archive |
Biospecimen Description |
9. Subject Eligibility
Study Population Description | Patients who had surgery under general anesthesia at Haeundae Paik Hospital and received sugammadex to reverse rocuronium-induced neuromuscular blockade |
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Sampling Method | Non-probability sampling (The samples were extracted by investigating the cases of sugammadex prescription during the period(complete observation between October 2017 and July 2018), and the information provided by Health Information Management department of Haeundae Paik Hospital.) |
Condition(s)/Problem(s) |
* (V01-Y98)External causes of morbidity and mortality (Y55.1)Skeletal muscle relaxants [neuromuscular blocking agents] causing adverse effects in therapeutic use Patients who had surgery under general anesthesia |
Rare Disease | No |
Inclusion Criteria |
Gender Both |
Age No Limit~No Limit |
|
Description Patients who had surgery under general anesthesia at Haeundae Paik Hospital and received intravenous sugammadex to reverse rocuronium-induced neuromuscular blockade |
|
Exclusion Criteria |
1) Patients whose monitoring parameters were lacking in electronic medical records (for example, BIS, end-tidal volatile anesthetic concentration, MAC) 2) Total intravenous anesthesia 3) Concomitant use of other reversal agents (for example, pyridostigmine) 4) Administration of sugammadex after extubation |
Healthy Volunteers | No |
10. Outcome Measure(s)
Type of Primary Outcome | /Safety/Efficacy | |
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Primary Outcome(s) 1 | ||
Outcome | occurrence and types of complications after extubation |
|
Timepoint | emergence from general anesthesia and tracheal extubation |
|
Secondary Outcome(s) 1 | ||
Outcome | time to extubate from discontinuation of anesthetics |
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Timepoint | tracheal extubation |
11. Study Results and Publication
Result Registered | No |
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12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)
Sharing Statement | No |
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