UMIN-CTR Clinical Trial

Public title

Efficacy of combination antipsychotic and benzodiazepines on delirium in patients with cancer: a systematic review

Acronym

Efficacy of combination antipsychotic and benzodiazepines on delirium: a systematic review

Scientific Title

Efficacy of combination antipsychotic and benzodiazepines on delirium in patients with cancer: a systematic review

Scientific Title:Acronym

Efficacy of combination antipsychotic and benzodiazepines on delirium: a systematic review

Region

Japan

Condition

Cancer

Classification by specialty

Hematology and clinical oncology

Psychiatry

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

To determine the efficacy of combination antipsychotic and benzodiazepines for delirium in patients with cacner

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Change in severity of delirium

Key secondary outcomes

Duration of delirium, respiratory depression, falls, tumbles

Study type

Others,meta-analysis etc

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

Age-lower limit

18

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

1.Patients with cancer (more than or equal to 80%)
2.Patient with delirium
3.Studies examining the efficacy of the administration of combination antipsychotic and benzodiazepines

The study design to be considered for inclusion is as follows:
1.If there were at least two randomized controlled trial (RCT)s, inclusion was completed.
2.If there were less than 2 RCTs, we included non-RCTs or observational studies with control groups.
3.If there were no RCTs/non-RCTs/observational studies with control groups, single-arm observational studies were considered for inclusion.

Key exclusion criteria

1.Duplicate publications
2.Conference proceedings

Target sample size

Name of lead principal investigator

1st name	Kazuyuki
Middle name
Last name	Niki

Organization

Osaka University /Ashiya Municipal Hospital

Division name

Graduate School of Pharmaceutical Sciences/ Department of Pharmacy

Zip code

565-0871

Address

1-6, Yamadaoka, Suita, Osaka, Japan

TEL

06-6879-8250

Email

k-niki@phs.osaka-u.ac.jp

Name of contact person

1st name	Kazuyuki
Middle name
Last name	Niki

Organization

Osaka University /Ashiya Municipal Hospital

Division name

Graduate School of Pharmaceutical Sciences/ Department of Pharmacy

Zip code

565-0871

Address

1-6, Yamadaoka, Suita, Osaka, Japan

TEL

06-6879-8250

Homepage URL

Email

k-niki@phs.osaka-u.ac.jp

Institute

Osaka University /Ashiya Municipal Hospital

Institute

Department

Personal name

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

N/A

Address

N/A

Tel

N/A

Email

N/A

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2023

Year

08

Month

04

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

Results

Results date posted

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Participant flow

Adverse events

Outcome measures

Plan to share IPD

IPD sharing Plan description

Recruitment status

Preinitiation

Date of protocol fixation

2023

Year

07

Month

31

Day

Date of IRB

Anticipated trial start date

2023

Year

09

Month

01

Day

Last follow-up date

2024

Year

08

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Data sources and search strategy
We will conduct a systematic review of randomized clinical trials investigating the efficacy of benzodiazepines alone for delirium in patients with cacner. This systematic review will search the following four databases: the Ichushi-Web of the Japan Medical Abstracts Society ver.5, Cochrane Library, EMBASE and MEDLINE, on 0831, 2023. The search will include all relevant terms such as "Delirium,""Benzodiazepines*," "major tranquilizer," "minor tranquilizer*," "Antipsychotic Agents," "haloperidol, " "quetiapine," "risperidone," "olanzapine," "perospirone," " chlorpromazine," "aripiprazole," "midazolam," and "lorazepam,"

Selection of studies and Assessment of risk of bias in included studies
Two review authors will independently check to ensure that studies meet the inclusion criteria. Two review authors will independently assess trial quality according to the Minds 2020 manual. If the raters disagree, the final rating will be made by consensus with the involvement, if necessary, of another
review author.

Registered date

2023

Year

08

Month

04

Day

Last modified on

2023

Year

08

Month

31

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059141