UMIN-CTR Clinical Trial

Public title

Maintenance of baroreflex sensitivity during intravenous sedation with a combination of propofol and midazolam

Acronym

Baroreflex sensitivity during intravenous sedation

Scientific Title

Maintenance of baroreflex sensitivity during intravenous sedation with a combination of propofol and midazolam

Scientific Title:Acronym

Baroreflex sensitivity during intravenous sedation

Region

Japan

Condition

mentally handicapped patient
dental phobia

Classification by specialty

Dental medicine

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

This study examines whether baroreflex sensitivity during intravenous sedation with a combination of propofol and midazolam is maintained at the same level as that with propofol only. Furthermore, we evaluate the safety of combination sedation on cardiovascular control systems at doses appropriate for mentally handicapped patients to accept medical treatment.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

For analysis of spontaneous baroreflex sensitivity, we examined continuous finger arterial pressure and electrocardiograms to detect sequence changes in the R-R interval with parallel changes in arterial pressure. Our software selected all of the sequences of three or more successive heart beats in which there were concordant increases or decreases in systolic blood pressure and R-R intervals. A linear regression was applied to each of the sequences, and the mean slope during each condition was assessed as baroreflex sensitivity.

Key secondary outcomes

Study type

Interventional

Basic design

Parallel

Randomization

Non-randomized

Randomization unit

Blinding

Single blind -participants are blinded

Control

Active

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

We also analyzed the effect of intravenous sedation with a combination of propofol and midazolam during dental treatment of a group of mentally handicapped adult patients to evaluate the maintenance of blood pressure in such subjects.

Interventions/Control_2

Intravenous sedation using propofol only during dental treatment of another group of handicapped patients was used as a control.

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

16

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

Only patients scheduled for dental treatment under intravenous sedative were recruited for this study. Written informed consent from parents or legal guardians was obtained following careful explanation of the study's procedure, risk, and benefits.
This study was performed according to guidelines set by the Declaration of Helsinki and was approved by the Institutional Review Board on Human Experiments of Matsumoto Dental University.

Key exclusion criteria

Patients with serious circulatory or respiratory diseases, epilepsy, egg or buckwheat allergies, or any other serious chronic diseases were excluded from experiments.

Target sample size

12

Name of lead principal investigator

1st name
Middle name
Last name	Sumida Sachi

Organization

Matsumoto Dental University

Division name

Department of Special Patients and Oral Care

Zip code

Address

1780,Goubara,Hirooka,Siojirisi,

TEL

Email

Name of contact person

1st name
Middle name
Last name

Organization

Matsumoto Dental University

Division name

Department of Special Patients and Oral Care

Zip code

Address

TEL

Homepage URL

Email

sumineko@po.mdu.ac.jp

Institute

Matsumoto Dental University

Institute

Department

Personal name

Organization

Nagano Society for the Promotion of Science

Organization

Division

Category of Funding Organization

Non profit foundation

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

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

2010

Year

08

Month

25

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

Completed

Date of protocol fixation

2010

Year

07

Month

30

Day

Date of IRB

Anticipated trial start date

2010

Year

08

Month

01

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2010

Year

08

Month

17

Day

Last modified on

2012

Year

02

Month

20

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004808