UMIN-ICDS Clinical Trial

Public title

Predicted Blood Concentration of Rocuronium and PTC Onset Time in Laparoscopic Surgery

Acronym

PTC Onset Time Study

Scientific Title

Predicted Blood Concentration of Rocuronium and PTC Onset Time in Laparoscopic Surgery

Scientific Title:Acronym

PTC Onset Time Study

Region

Japan

Condition

elective laparoscopic surgery cases from January 2021 to October 2023

Classification by specialty

Anesthesiology

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To clarify the appropriate dosage of muscle relaxants in laparoscopic surgery according to age.

Basic objectives2

Pharmacokinetics

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Whether there is a significant difference in the concentration of rocuronium effect site at the first appearance of PTC 1-3 between the two groups, with the younger group defined as younger than 70 years old and the older group defined as older than 70 years old

Key secondary outcomes

Study type

Observational

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

20

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

elective laparoscopic surgery cases from January 2021 to October 2023

Key exclusion criteria

Incomplete records, cases with abnormal hepatic or renal function, preoperative use of drugs that act on muscle relaxation, cases with a history of muscle relaxation effects, and cases in which the dose of rocuronium administered during induction of anesthesia differs significantly from that in the package insert.

Target sample size

100

Name of lead principal investigator

1st name	Michiyoshi
Middle name
Last name	Sanuki

Organization

National Hospital Organization Kure Medical Center and Chugoku Cancer Center

Division name

Department of Anesthesiology

Zip code

737-0023

Address

3-1 Aoyamacho, Kure-shi, Hiroshima

TEL

0823-22-3111

Email

mae.yuhei.eh@mail.hosp.go.jp

Name of contact person

1st name	Yuhei
Middle name
Last name	Mae

Organization

National Hospital Organization Kure Medical Center and Chugoku Cancer Center

Division name

Department of Anesthesiology

Zip code

737-0023

Address

3-1 Aoyamacho, Kure-shi, Hiroshima

TEL

0823-22-3111

Homepage URL

Email

mae.yuhei.eh@mail.hosp.go.jp

Institute

National Hospital Organization Kure Medical Center and Chugoku Cancer Center

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

National Hospital Organization Kure Medical Center and Chugoku Cancer Center

Address

3-1 Aoyamacho, Kure-shi, Hiroshima

Tel

0823-22-3111

Email

yano.keigo.yf@mail.hosp.go.jp

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

11

Month

30

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

150

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

No longer recruiting

Date of protocol fixation

2023

Year

11

Month

17

Day

Date of IRB

2023

Year

11

Month

17

Day

Anticipated trial start date

2023

Year

11

Month

17

Day

Last follow-up date

2024

Year

10

Month

01

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

A cross-sectional study of the aforementioned patients. As a secondary endpoint, we will also examine whether there is a difference in effect site concentration between the normal and low Alb groups as well.
The following items will be extracted from the medical records:
Age, gender, height, weight, medical history, preoperative medications administered, preoperative consultation information, anesthesia record information, diagnosis, surgical procedure, anesthetic and muscle relaxant rocuronium dose, ASA classification, each blood test value (BUN, Cre, AST, ALT, LD, ALP, gamma GTP, ChE, t-Bil, i-Bil, PT (% and sec), PT-INR, RBC, WBC, PLT, Alb), and preoperative medications.From the anesthesia recording device,
rocuronium administration record and blood concentration of rocuronium calculated by the PkPD simulator built into the anesthesia recorder, effect site concentration, PTC count in PTC mode automatically captured from the muscle relaxation monitor, parameters in TOF mode (PTC, TOF count, TOF ratio, T1 ), time of drug administration, time PTC1-3 was observed, vital signs

Registered date

2023

Year

11

Month

26

Day

Last modified on

2023

Year

11

Month

26

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000060367