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

Email

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


Email

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

Email

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name