UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000012744
Receipt number R000014890
Scientific Title Effects of a novel method of anesthesia combining propofol and volatile anesthesia on the incidence of postoperative nausea and vomiting in patients undergoing laparoscopic gynecological surgery
Date of disclosure of the study information 2014/01/01
Last modified on 2016/12/26 13:16:45

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Basic information

Public title

Effects of a novel method of anesthesia combining propofol and volatile anesthesia on the incidence of postoperative nausea and vomiting in patients undergoing laparoscopic gynecological surgery

Acronym

Effects of a novel method of anesthesia combining propofol and volatile anesthesia on the incidence of postoperative nausea and vomiting in patients undergoing laparoscopic gynecological surgery

Scientific Title

Effects of a novel method of anesthesia combining propofol and volatile anesthesia on the incidence of postoperative nausea and vomiting in patients undergoing laparoscopic gynecological surgery

Scientific Title:Acronym

Effects of a novel method of anesthesia combining propofol and volatile anesthesia on the incidence of postoperative nausea and vomiting in patients undergoing laparoscopic gynecological surgery

Region

Japan


Condition

Condition

Patients scheduled for elective laparoscopic gynecological surgery

Classification by specialty

Obstetrics and Gynecology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

We investigate the effects of a novel method of anesthesia combining propofol and volatile anesthesia on the incidence of postoperative nausea and vomiting in patients undergoing laparoscopic gynecological surgery

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Complete response (no postoperative nausea and vomiting and no rescue antiemetic use) rate within 24 h of surgery

Key secondary outcomes

Incidence of nausea and vomiting
Nausea severity score
Vomiting frequency
Rescue antiemetic use
Postoperative pain


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit


Blinding

Double blind -all involved are blinded

Control

Active

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

3

Purpose of intervention

Prevention

Type of intervention

Medicine

Interventions/Control_1

In the sevoflurane/propofol group, anesthesia is maintained with combined propofol and sevoflurane.

Interventions/Control_2

In the sevoflurane group, anesthesia is maintained with sevoflurane.

Interventions/Control_3

In the propofol group, anesthesia was maintained with an infusion of propofol.

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

18 years-old <=

Age-upper limit


Not applicable

Gender

Female

Key inclusion criteria

Patients scheduled for elective laparoscopic gynecological surgery under general endotracheal anesthesia, with an American Society of Anesthesiologists (ASA) physical status of I and II.

Key exclusion criteria

Obesity (body mass index > 33 kg/m2) Neurological, renal, or liver disease
Use of drugs with antiemetic properties,including corticosteroids

Target sample size

130


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Hiroaki Kawano

Organization

Tokushima Prefectural Central Hospital

Division name

Department of Anesthesiology

Zip code


Address

1-10-3 Kuramoto, Tokushima 770-8539, Japan

TEL

088-633-7151

Email

hir.kawano@gmail.com


Public contact

Name of contact person

1st name
Middle name
Last name Hiroaki Kawano

Organization

Tokushima Prefectural Central Hospital

Division name

Department of Anesthesiology

Zip code


Address

1-10-3 Kuramoto, Tokushima 770-8539, Japan

TEL

088-633-7151

Homepage URL


Email

hir.kawano@gmail.com


Sponsor or person

Institute

Department of Anesthesiology, Tokushima University Hospita

Institute

Department

Personal name



Funding Source

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



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

徳島大学病院


Other administrative information

Date of disclosure of the study information

2014 Year 01 Month 01 Day


Related information

URL releasing protocol


Publication of results

Published


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

Completed

Date of protocol fixation

2008 Year 12 Month 01 Day

Date of IRB


Anticipated trial start date

2009 Year 02 Month 01 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2014 Year 01 Month 01 Day

Last modified on

2016 Year 12 Month 26 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014890


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name