UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042568 |
|---|---|
| Receipt number | R000047729 |
| Scientific Title | Comparison of recovery profile after remimazolam-remifentanil anesthesia and propofol-remifentanil anesthesia in elderly patients undergoing spinal surgery: a prospective randomized trial |
| Date of disclosure of the study information | 2020/11/26 |
| Last modified on | 2024/02/29 08:04:13 |
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Basic information
Public title
Comparison of recovery profile after remimazolam-remifentanil anesthesia and propofol-remifentanil anesthesia in elderly patients undergoing spinal surgery
Acronym
Investigation of recovery profile after remimazolam-remifentanil anesthesia in elderly patients undergoing spinal surgery
Scientific Title
Comparison of recovery profile after remimazolam-remifentanil anesthesia and propofol-remifentanil anesthesia in elderly patients undergoing spinal surgery: a prospective randomized trial
Scientific Title:Acronym
Comparison of recovery profile after remimazolam-remifentanil anesthesia and propofol-remifentanil anesthesia in elderly patients undergoing spinal surgery
Region
| Japan |
Condition
Condition
patients undergoing spinal surgery
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare recovery profile after remimazolam-remifentanil anesthesia and propofol-remifentanil anesthesia in elderly patients undergoing spinal surgery
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Time from the end of anesthetic administration to extubate a tracheal tube
Key secondary outcomes
Time from the end of anesthetic administration to open eyes, to be able to respond to a call, and to reach an Aldrate Anesthesia Awakening Score of 12 or higher
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
The administration of remimazolam and remifentanil to maintain general anesthesia
Interventions/Control_2
The administration of propofol and remifentanil to maintain general anesthesia
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
| 75 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients scheduled for spine surgery
Key exclusion criteria
Patients with hepatic dysfunction of Child-Pugh classification B or higher
Patients receiving renal replacement therapy
Severely obese patients (Body mass index 35 or higher)
Dementia patients
Non-standard spinal cord surgery
Patients who are allergic to anesthetics
Target sample size
44
Research contact person
Name of lead principal investigator
| 1st name | Takashi |
| Middle name | |
| Last name | Kondo |
Organization
Hiroshima University Hospital
Division name
anesthesiology
Zip code
7348551
Address
1-2-3, Kasumi, Minami-ku, Hiroshima
TEL
0822575267
kondo320@hiroshima-u.ac.jp
Public contact
Name of contact person
| 1st name | Takashi |
| Middle name | |
| Last name | Kondo |
Organization
Hiroshima University Hospital
Division name
anesthesiology
Zip code
7348551
Address
1-2-3, Kasumi, Minami-ku, Hiroshima
TEL
0822575267
Homepage URL
kondo320@hiroshima-u.ac.jp
Sponsor or person
Institute
Hiroshima University Hospital
Department of Anesthesiology
Institute
Department
Personal name
Funding Source
Organization
Hiroshima University Hospital
Department of Anesthesiology
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethical Committee for Clinical Research of Hiroshima University
Address
1-2-3, Kasumi, Minami-ku, Hiroshima
Tel
0822571551
iryo-seisaku@office.hiroshima-u.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
広島大学病院（広島県）、広島県厚生農業協同組合連合会 JA広島総合病院(広島県)
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 11 | Month | 26 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
44
Results
Thirty-nine patients were finally analyzed: remimazolam group (n = 20), propofol group (n = 19). There were no significant differences in intraoperative variables, such as operative time, anesthesia time, and patient background, between the 2 groups. Extubation times were significantly shorter in the remimazolam group than in the propofol group. The time to eye opening, obeying commands, and achieving a white fast-track score of 12 were significantly shorter in the remimazolam group.
Results date posted
| 2024 | Year | 02 | Month | 22 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2024 | Year | 02 | Month | 22 | Day |
Baseline Characteristics
Patient demographics revealed no significant differences in background characteristics between the 2 groups. The numbers of patients treated with antipsychotics, anxiolytics, hypnotics, antidementia drugs, and antiparkinsonian drugs were not significantly different.
Participant flow
Forty-four patients were enrolled between January 2021 and September 2022 and were randomly allocated to either group R (n = 22) or group P (n = 22). Following randomization, 2 patients declined to participate. One patient was unable to receive the allocated intervention because there was no anesthesiologist available to conduct this study because of emergency surgeries. Thereafter, one additional patient in group P discon- tinued the allocated intervention because of severe hypotension during anesthesia induction. Excluding 1 patient who deviated from the protocol, thirty-nine patients were finally analyzed in this study (group R, n = 20; group P, n = 19).
Adverse events
One case in propofol group discontinued the allocated intervention because of severe hypotension during anesthesia induction. Fortunately, the anesthetic was changed and the surgery was completed as planned. Postoperatively, there were no obvious adverse events due to anesthesia.
Outcome measures
Extubation times were significantly shorter in the remimazolam group than in the propofol group (4 vs 8 minutes, P < .001). The time to eye opening, obeying commands, and achieving a WFTS of 12 were significantly shorter in the remimazolam group (P < .001, for all comparisons).
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2020 | Year | 11 | Month | 17 | Day |
Date of IRB
| 2020 | Year | 11 | Month | 25 | Day |
Anticipated trial start date
| 2020 | Year | 11 | Month | 25 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 11 | Month | 26 | Day |
Last modified on
| 2024 | Year | 02 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047729
