UMIN-CTR Clinical Trial

Public title

Prevention of residual neuromuscular blockade with sugammadex in patients received general anesthesia

Acronym

Prevention of residual neuromuscular blockade with sugammadex

Scientific Title

Prevention of residual neuromuscular blockade with sugammadex in patients received general anesthesia

Scientific Title:Acronym

Prevention of residual neuromuscular blockade with sugammadex

Region

Japan

Condition

Diseases which need operation under general anesthesia

Classification by specialty

Anesthesiology

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

It is pointed out when the recovery of neuromuscular function is not enough after surgery, serious respiratory disorders such as oxygen desaturation will emerge at a high rate. Our previous multicenter study found the incidence of residual neuromuscular blockade in 22% of patients after general anesthesia. In this study we investigate the incidence of residual neuromuscular blockade after administration of sugammadex for reversal of neuromuscular blockade.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

The number of patients whose TOF ratio <0.9 after tracheal extubation

Key secondary outcomes

1. Existence or nonexistence of pulmonary or other complication after surgery
2. Total rocuronium dose
3. Time from extubation to measurement of TOF ratio
4. Time from latest rocuronium use to extubation
5. Time from administration of sugammadex to extubation
6. The difference of TOF ratio among the ages and the anesthetic managements

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

1. Induction and maintenance of anesthesia is done with anesthetics and analgesics which are appropriate for the surgical patients' conditions. Either inhalational anesthesia or TIVA is allowed.
2. Tracheal intubation is done after adequate dose of rocronium is injected.
3. Intraoperative rocuronium useage is determined by the anesthesiologist.
4. After surgery, recovery of neuromuscular blockade is done by intravenous administration of sugammadex. The dose is 2mg/kg after confirmation of spontaneous breathing or 4mg/kg before confirmation of spontaneous breathing.
5. After confirmation of recovery from neuromuscular blockade subjectively by respiration or muscular strengh, tracheal extubation is done.
6. After extubation and the patients are stable, TOF ratio at the thumb is measured by neuromuscular monitor(TOF-Watch) giving TOF stimulation(50mA) to ulnar nerve at fifteen seconds interval. When the difference of two data is over 10%, the measuring repeats until four mesuring is done. The measuring is done with hand adaptor.
7. When the TOF ratio<0.9, the reversal with sugammadex is considered once agein and the respiratory condition is checkd. When the reversal is done once again, another TOF ratio is measured.

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

Patients, aged 20 or over (ASA phisical status 1-3) and who is operated under general anesthesia using rocuronium as neuromuscular blocking agent and sugammadex as neuromuscular reversal agent.

Key exclusion criteria

Patients who have a history of hypersensitivity to rocuronium and bromide.
Patients who have a history of hypersensitivity to sugammadex.
Patients who have myasthenia gravis and myasthenic syndrome.

Target sample size

25

Name of lead principal investigator

1st name
Middle name
Last name	Itsuo Nakatsuka

Organization

Keio University Hospital

Division name

Department of Anesthesiology

Zip code

Address

35 Shinanomachi, Shinjuku-ku, Tokyo, Japan

TEL

Email

Name of contact person

1st name
Middle name
Last name

Organization

Keio University Hospital

Division name

Department of Anesthesiology

Zip code

Address

35 Shinanomachi, Shinjuku-ku, Tokyo, Japan

TEL

Homepage URL

Email

Institute

Tokyo Neuromuscular Meeting

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

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

11

Month

08

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

09

Month

27

Day

Date of IRB

Anticipated trial start date

2010

Year

11

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

11

Month

08

Day

Last modified on

2011

Year

05

Month

09

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005399