UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000043518
Receipt number R000049690
Scientific Title Comparison of reversal with neostigmine vs. sugammadex for postoperative bowel function in patients undergoing colorectal surgery
Date of disclosure of the study information 2021/09/14
Last modified on 2024/02/20 09:35:45

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Basic information

Public title

Comparison of reversal with neostigmine vs. sugammadex for postoperative bowel function in patients undergoing colorectal surgery

Acronym

comparison of reversal with neostsigmine and sugammadex for post.op bowel function in patients undergoing colorectal surg.

Scientific Title

Comparison of reversal with neostigmine vs. sugammadex for postoperative bowel function in patients undergoing colorectal surgery

Scientific Title:Acronym

comparison of reversal with neostsigmine and sugammadex for post.op bowel function in patients undergoing colorectal surg.

Region

Asia(except Japan)


Condition

Condition

colorectal surgery

Classification by specialty

Gastrointestinal surgery

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The purpose of this study was to investigate the difference in bowel function after surgery between the patients receiving neostigmine as a muscle relaxation reversal and those receiving sugammadex in patients undergoing colorectal surgery under general anesthesia.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Explanatory

Developmental phase

Not applicable


Assessment

Primary outcomes

Evaluating the time taken to expel gas in the first intestine after surgery

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Active

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

sugammadex

Interventions/Control_2

neostigmine

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

19 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

1. Patients in the American Society of Anesthesiology class 1 and 2
2. Patients planning colorectal surgery under general anesthesia
3. Patients with prior consent to the study

Key exclusion criteria

1. Patients who have been given drugs that affect muscle relaxation recovery (anticonvulsants, antidepressants, etc.)
2. Patients who had history of neuromuscular diseases
3. Patients with hypersensitivity to rocuronium, neostigmine, and sugammadex
4. Patients with liver disease (OT/PT> 40 IU/L), kidney disease (Cr> 1.4 mg/dl)
5. Patients with with bowel obstruction
6. Patients who disagree with the test

Target sample size

122


Research contact person

Name of lead principal investigator

1st name JINWOO
Middle name
Last name PARK

Organization

Seoul national university Bundang hospital

Division name

Anesthesiology and pain medicine

Zip code

13620

Address

82 Gumi-ro 173beon-gil, Bundang-gu, Seongnam-si, Gyeonggi-do, Republic of Korea

TEL

+82317873640

Email

jinul8282@snubh.org


Public contact

Name of contact person

1st name JIYOUN
Middle name
Last name LEE

Organization

Seoul national university Bundang hospital

Division name

Anesthesiology and pain medicine

Zip code

13620

Address

82 Gumi-ro 173beon-gil, Bundang-gu, Seongnam-si, Gyeonggi-do, Republic of Korea

TEL

+82317873640

Homepage URL


Email

heykiki1@hanmail.net


Sponsor or person

Institute

self

Institute

Department

Personal name



Funding Source

Organization

MSD Korea Ltd.(MSD has decided to offer sugammadex drugs in-kind.)

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Seoul national university Bundang hospital

Address

172 Dolma-ro, Bundang-gu, Seongnam-si, Gyeonggi-do, Republic of Korea

Tel

+82317878801

Email

snubhirb@gmail.com


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



Other administrative information

Date of disclosure of the study information

2021 Year 09 Month 14 Day


Related information

URL releasing protocol


Publication of results

Unpublished


Result

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



Progress

Recruitment status

Terminated

Date of protocol fixation

2020 Year 11 Month 01 Day

Date of IRB

2021 Year 02 Month 26 Day

Anticipated trial start date

2022 Year 05 Month 12 Day

Last follow-up date

2023 Year 07 Month 07 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2021 Year 03 Month 04 Day

Last modified on

2024 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=R000049690


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name