Unique ID issued by UMIN | UMIN000042380 |
---|---|
Receipt number | R000048348 |
Scientific Title | Research for postoperative analgesia and nausea and vomiting after gynecological laparoscopic surgery |
Date of disclosure of the study information | 2021/05/25 |
Last modified on | 2023/05/11 16:06:45 |
The postoperative analgesia of TAPA block and the comparison of the postoperative nausea and vomiting between remimazolam and propofol anesthesia in patients with gynecological laparoscopic surgery
Research for postoperative analgesia and nausea and vomiting after gynecological laparoscopic surgery
Research for postoperative analgesia and nausea and vomiting after gynecological laparoscopic surgery
Research for postoperative analgesia and nausea and vomiting in patients with gynecological laparoscopic surgery
Japan |
the patients who have laparoscopic ovariectomy or laparoscopic hysterectomy
Obstetrics and Gynecology | Anesthesiology |
Others
NO
The analgesia of TAPA block and postoperative nausea and vomiting with Remimazolam will be evaluated in comparison with the case of no block and the case of propofol.
Safety,Efficacy
Primary outcomes: postoperative pain assessment during rest or movement (VAS), time to use additional analgesics after awakening, IVPCA bolus usage
Secondary outcomes: nausea, vomiting, antiemetics, presence of side effects
Interventional
Parallel
Randomized
Individual
Open -but assessor(s) are blinded
Active
4
Treatment
Medicine | Maneuver |
intraoperative propofol
introduction: 1 mg/kg/hour
Maintenance: Start at 8 mg/kg/hour, increase or decrease as appropriate
TAPA block
Drugs: 0.25% levobupivacaine
Dosage: 20 ml
intraoperative remimazolam
introduction: 12 mg/kg/hour
Maintenance: Start at 1 mg/kg/hour, increase or decrease as appropriate
TAPA block
Drugs: 0.25% levobupivacaine
Dosage: 20 ml
intraoperative propofol
introduction: 1 mg/kg/hour
Maintenance: Start at 8 mg/kg/hour, increase or decrease as appropriate
no block
intraoperative remimazolam
introduction: 12 mg/kg/hour
Maintenance: Start at 1 mg/kg/hour, increase or decrease as appropriate
no block
20 | years-old | <= |
Not applicable |
Female
1) Patients over the age of 20
2) Patients who have laparoscopic oophorectomy, hysterectomy, and uterine enucleation
3) Patients who consented before surgery
Cases that fall under any of the following are not included in this study.
1) Patients under the age of 20
2) Patients with ASA classification 3 or higher
3) Patients with a history of hypersensitivity to the drugs used in this study, Patients with hypertension
4) Patients who are judged to be unsuitable by the doctor responsible for the research institution
60
1st name | Atsushi |
Middle name | |
Last name | Unuma |
Akita University Graduate School of Medicine
Anesthesia and Intensive Care Medicine
010-8543
1-1-1, Hondo, Akita-city, Akita
018-884-6175
unuma18@med.akita-u.ac.jp
1st name | Atsushi |
Middle name | |
Last name | Unuma |
Akita University Graduate School of Medicine
Anesthesia and Intensive Care Medicine
010-8543
1-1-1, Hondo, Akita-city, Akita
018-884-6175
unuma18@med.akita-u.ac.jp
Akita University
Akita University
Other
IRB
1-1-1, Hondo, Akita-city, Akita
018-884-6216
soken@hos.akita-u.ac.jp
NO
秋田大学医学部附属病院
2021 | Year | 05 | Month | 25 | Day |
Unpublished
No longer recruiting
2020 | Year | 10 | Month | 21 | Day |
2020 | Year | 10 | Month | 21 | Day |
2020 | Year | 11 | Month | 10 | Day |
2023 | Year | 08 | Month | 31 | Day |
2023 | Year | 08 | Month | 31 | Day |
2023 | Year | 08 | Month | 31 | Day |
2023 | Year | 08 | Month | 31 | Day |
2020 | Year | 11 | Month | 07 | Day |
2023 | Year | 05 | Month | 11 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048348