UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055556 |
|---|---|
| Receipt number | R000063487 |
| Scientific Title | Quality of Postoperative Recovery Based on Intraoperative Changes in General Anesthetics: A Retrospective Observational Study |
| Date of disclosure of the study information | 2024/09/20 |
| Last modified on | 2026/03/24 10:43:57 |
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Basic information
Public title
Quality of Postoperative Recovery Based on Intraoperative Changes in General Anesthetics: A Retrospective Observational Study
Acronym
Quality of Postoperative Recovery Based on Intraoperative Changes in General Anesthetics: A Retrospective Observational Study
Scientific Title
Quality of Postoperative Recovery Based on Intraoperative Changes in General Anesthetics: A Retrospective Observational Study
Scientific Title:Acronym
Quality of Postoperative Recovery Based on Intraoperative Changes in General Anesthetics: A Retrospective Observational Study
Region
| Japan |
Condition
Condition
General anesthesia
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate whether the single general anesthetic administration group has fewer perioperative adverse events compared to the combined general anesthetic administration group
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Perioperative Complications (Postoperative Nausea and Vomiting, Delayed Emergence)
Key secondary outcomes
Mortality Within 7 and 28 Days Postoperatively, In-Hospital Mortality, and Unplanned ICU Admission
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Receiving general anesthetic(s) (single or multiple, regardless of type)
The course of general anesthesia is electronically recorded
Key exclusion criteria
Data gaps
Target sample size
10000
Research contact person
Name of lead principal investigator
| 1st name | Yuji |
| Middle name | |
| Last name | Suzuki |
Organization
Hamamatsu University Hospital
Division name
Department of Anesthesiology and Intensive Care Medicine
Zip code
4313192
Address
1-20-1, Handayama, Chuoh-ku, Hamamatsu, Japan
TEL
0534352738
suzukiy@hama-med.ac.jp
Public contact
Name of contact person
| 1st name | Yuji |
| Middle name | |
| Last name | Suzuki |
Organization
Hamamatsu University School of Medicine
Division name
Department of Anesthesiology and Intensive Care Medicine
Zip code
4313192
Address
1-20-1, Handayama, Chuoh-ku, Hamamatsu, Japan
TEL
0534352738
Homepage URL
suzukiy@hama-med.ac.jp
Sponsor or person
Institute
Hamamatsu University School of Medicine
Institute
Department
Personal name
Yuji Suzuki
Funding Source
Organization
Self funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee for Life Science and Medical Research, Hamamatsu University School of Medicine
Address
1-20-1, Handayama, Chuoh-ku, Hamamatsu, Japan
Tel
0534352680
rinri@hama-med.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 09 | Month | 20 | Day |
Related information
URL releasing protocol
https://msanuki.com/jsiva31/program.html
Publication of results
Published
Result
URL related to results and publications
https://msanuki.com/jsiva31/program.html
Number of participants that the trial has enrolled
1183
Results
This study evaluated the association between PONV and anesthetic regimen changes. Among 1,183 spinal surgery patients, those with MEP monitoring were included. Patients received either propofol alone (n = 208) or were switched from propofol to desflurane (n = 111). The incidence of PONV within 24 hours did not differ significantly between groups, suggesting that anesthetic switching does not affect PONV development.
Results date posted
| 2026 | Year | 03 | Month | 24 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Patients who underwent spinal surgery during the study period were included. The exclusion criteria were as follows: cases in which MEP was not performed during surgery; cases managed with anesthesia other than total intravenous anesthesia during MEP monitoring; cases in which total intravenous anesthesia was performed using agents other than propofol; cases in which anesthetic agents other than desflurane were introduced after completion of MEP monitoring; cases in which patients were not extubated at the end of surgery; cases in which surgery was performed in positions other than the prone position; and cases with missing data.
Participant flow
A total of 1,183 patients underwent spinal surgery during the study period. Of these, 864 patients were excluded. The reasons for exclusion were as follows: absence of MEP monitoring (n = 478), management with anesthesia other than total intravenous anesthesia (n = 46), total intravenous anesthesia performed using agents other than propofol (n = 152), use of anesthetic agents other than desflurane after completion of MEP monitoring (n = 41), failure to extubate at the end of surgery (n = 16), surgery performed in positions other than the prone position (n = 41), and missing data (n = 90).
Ultimately, 208 patients in the propofol-only group and 111 patients in the group switched from propofol to desflurane were included in the analysis. For sensitivity analysis, propensity score matching was performed, resulting in a matched cohort of 97 patients in each group.
Adverse events
Regarding adverse events, this study was based on a retrospective review of electronic medical records; therefore, no adverse events attributable to the study itself could occur.
Outcome measures
The primary outcome was PONV occurring within 24 hours postoperatively. PONV was determined based on postoperative assessments by anesthesiologists, routinely recorded postoperative nursing records, and the administration of rescue antiemetic medications.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2024 | Year | 09 | Month | 19 | Day |
Date of IRB
| 2023 | Year | 08 | Month | 08 | Day |
Anticipated trial start date
| 2024 | Year | 09 | Month | 20 | Day |
Last follow-up date
| 2024 | Year | 09 | Month | 20 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
A retrospective investigation of electronic records of patients who underwent surgery at Hamamatsu University Hospital's Surgical Center. The study aims to examine patient demographics, general anesthetics and adjunctive drugs used, and postoperative recovery parameters (extubation time, discharge from the operating room time, incidence of perioperative nausea and vomiting, delirium occurrence, etc.), to identify factors associated with postoperative adverse events. Patient groups will be stratified or matched between groups as necessary.
Management information
Registered date
| 2024 | Year | 09 | Month | 20 | Day |
Last modified on
| 2026 | Year | 03 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063487
