UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000010617
Receipt number R000012414
Scientific Title The Effects of Epidural Anesthesia on Postoperative Nausea and Vomiting in Patients Undergoing Laparoscopic Gynecologic Surgery
Date of disclosure of the study information 2013/05/06
Last modified on 2022/12/08 06:38:02

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Basic information

Public title

The Effects of Epidural Anesthesia on Postoperative Nausea and Vomiting in Patients Undergoing Laparoscopic Gynecologic Surgery

Acronym

The Effects of Epidural Anesthesia on Postoperative Nausea and Vomiting in Patients Undergoing Laparoscopic Gynecologic Surgery

Scientific Title

The Effects of Epidural Anesthesia on Postoperative Nausea and Vomiting in Patients Undergoing Laparoscopic Gynecologic Surgery

Scientific Title:Acronym

The Effects of Epidural Anesthesia on Postoperative Nausea and Vomiting in Patients Undergoing Laparoscopic Gynecologic Surgery

Region

Japan


Condition

Condition

Patients undergoing laparoscopic gynecologic surgery.

Classification by specialty

Obstetrics and Gynecology Anesthesiology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the effect of epidural anesthesia combined with general anesthesia on postoperative nausea and vomiting (PONV) in patients undergoing laparoscopic gynecologic surgery.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

The incidence of PONV during 24h after the surgery.

Key secondary outcomes

The incidence of nausea, the number of vomiting and the use of rescue antiemetics administered at the post-anesthetic care unit and three postoperative intervals (T2: 0-2h, T12: 2-12h and T24: 12-24h) and total amount of rescue analgesics administered for 24h post-operation.


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -but assessor(s) are blinded

Control

Active

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Maneuver

Interventions/Control_1

General anesthesia

Interventions/Control_2

General anesthesia combined with epidural anesthesia

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

18 years-old <=

Age-upper limit


Not applicable

Gender

Female

Key inclusion criteria

Patients who meet two or more criteria in Apfel's simplified score. (Female gender, non-smoker, motion sickness or history of PONV and postoperative opioid use).

Key exclusion criteria

Emergency surgery
Contraindication to the use of any of the study medications
Contraindication to epidural anesthesia
Patients who took antiemetics and/or analgesics within 24h prior to the surgery

Target sample size

90


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Hiroyuki Seki

Organization

Saiseikai Central Hospital

Division name

Department of Anesthesiology

Zip code


Address

4-17, Mita 1-chome, Minato-ku, Tokyo

TEL

03-3451-8211

Email

hshiroyukiseki@gmail.com


Public contact

Name of contact person

1st name
Middle name
Last name Itsuo Nakatsuka

Organization

Saiseikai Central Hospital

Division name

Department of Anesthesiology

Zip code


Address

4-17, Mita 1-chome, Minato-ku, Tokyo

TEL

03-3451-8211

Homepage URL


Email

PFA03271@nifty.com


Sponsor or person

Institute

Saiseikai Central Hospital

Institute

Department

Personal name



Funding Source

Organization

None

Organization

Division

Category of Funding Organization

Non profit foundation

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



Other administrative information

Date of disclosure of the study information

2013 Year 05 Month 06 Day


Related information

URL releasing protocol

doi: https://doi.org/10.1101/2020.11.27.20239582

Publication of results

Published


Result

URL related to results and publications

https://researchmap.jp/read0121590/published_papers/39622892

Number of participants that the trial has enrolled

210

Results

Seventy-two (68%) patients in the control group and 56 (54%) patients in the olanzapine group experienced postoperative nausea and vomiting within 24 hours (pooled relative risk, 0.792; 95% CI, 0.634-0.988).

Results date posted

2022 Year 12 Month 08 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics

Age, height, weight, BMI, and the number of risk factors for PONV were similar in both groups.

Participant flow

Among 213 randomized patients, 210 (99%) patients completed the trial and comprised the modified intention-to-treat population for data analysis.

Adverse events

There were no differences in the incidence of pre-specified adverse reactions between the groups.

Outcome measures

The primary outcome was the incidence of postoperative nausea and vomiting within 24 hours after surgery. Secondary endpoints included longitudinal changes in the incidence of postoperative nausea and vomiting.

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2013 Year 04 Month 19 Day

Date of IRB


Anticipated trial start date

2013 Year 05 Month 07 Day

Last follow-up date

2014 Year 03 Month 31 Day

Date of closure to data entry

2014 Year 03 Month 31 Day

Date trial data considered complete

2014 Year 03 Month 31 Day

Date analysis concluded

2014 Year 09 Month 30 Day


Other

Other related information



Management information

Registered date

2013 Year 04 Month 30 Day

Last modified on

2022 Year 12 Month 08 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012414


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name