Unique ID issued by UMIN | UMIN000010617 |
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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 |
The Effects of Epidural Anesthesia on Postoperative Nausea and Vomiting in Patients Undergoing Laparoscopic Gynecologic Surgery
The Effects of Epidural Anesthesia on Postoperative Nausea and Vomiting in Patients Undergoing Laparoscopic Gynecologic Surgery
The Effects of Epidural Anesthesia on Postoperative Nausea and Vomiting in Patients Undergoing Laparoscopic Gynecologic Surgery
The Effects of Epidural Anesthesia on Postoperative Nausea and Vomiting in Patients Undergoing Laparoscopic Gynecologic Surgery
Japan |
Patients undergoing laparoscopic gynecologic surgery.
Obstetrics and Gynecology | Anesthesiology |
Others
NO
To evaluate the effect of epidural anesthesia combined with general anesthesia on postoperative nausea and vomiting (PONV) in patients undergoing laparoscopic gynecologic surgery.
Efficacy
The incidence of PONV during 24h after the surgery.
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.
Interventional
Parallel
Randomized
Individual
Open -but assessor(s) are blinded
Active
2
Treatment
Maneuver |
General anesthesia
General anesthesia combined with epidural anesthesia
18 | years-old | <= |
Not applicable |
Female
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).
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
90
1st name | |
Middle name | |
Last name | Hiroyuki Seki |
Saiseikai Central Hospital
Department of Anesthesiology
4-17, Mita 1-chome, Minato-ku, Tokyo
03-3451-8211
hshiroyukiseki@gmail.com
1st name | |
Middle name | |
Last name | Itsuo Nakatsuka |
Saiseikai Central Hospital
Department of Anesthesiology
4-17, Mita 1-chome, Minato-ku, Tokyo
03-3451-8211
PFA03271@nifty.com
Saiseikai Central Hospital
None
Non profit foundation
NO
2013 | Year | 05 | Month | 06 | Day |
doi: https://doi.org/10.1101/2020.11.27.20239582
Published
https://researchmap.jp/read0121590/published_papers/39622892
210
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).
2022 | Year | 12 | Month | 08 | Day |
Age, height, weight, BMI, and the number of risk factors for PONV were similar in both groups.
Among 213 randomized patients, 210 (99%) patients completed the trial and comprised the modified intention-to-treat population for data analysis.
There were no differences in the incidence of pre-specified adverse reactions between the groups.
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.
Completed
2013 | Year | 04 | Month | 19 | Day |
2013 | Year | 05 | Month | 07 | Day |
2014 | Year | 03 | Month | 31 | Day |
2014 | Year | 03 | Month | 31 | Day |
2014 | Year | 03 | Month | 31 | Day |
2014 | Year | 09 | Month | 30 | Day |
2013 | Year | 04 | Month | 30 | Day |
2022 | Year | 12 | Month | 08 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012414
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