UMIN-CTR Clinical Trial

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	Obsterics 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
Institute	Saiseikai Central Hospital
Institute
Department

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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012414