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Japanese

July. 22, 2026

Aug. 21, 2026

jRCT1052260116

Assessment of the Quality of Postoperative Recovery
after Robotic Anesthesia
(ARORA Study)

Study of Recovery after Robotic Anesthesia

Kamata Kotoe

Tohoku University Hospital

1-1 Seiryo-machi,Aoba-ku,Sendai,Miyagi

+81-22-717-7321

kotoe.kamata.c3@tohoku.ac.jp

Kamata Kotoe

Tohoku University Hospital

1-1 Seiryo-machi,Aoba-ku,Sendai,Miyagi

+81-22-717-7321

kotoe.kamata.c3@tohoku.ac.jp

Recruiting

July. 22, 2026

Aug. 07, 2026
116

Interventional

randomized controlled trial

single blind

placebo control

parallel assignment

treatment purpose

1. Patients scheduled to undergo urological robotic surgery under general anesthesia at Tohoku University Hospital
2. Patients aged 18 years or older at the time of consent
3. Patients from whom written informed consent for participation in this study has been obtained

1. Patients with a known allergy to any of the study drugs
2. Patients with severe systemic disease, defined as an American Society of Anesthesiologists physical status of III or higher
3. Patients with central nervous system disorders or psychiatric disorders
4. Patients receiving long-term treatment with centrally acting medications
5. Patients with heavy alcohol consumption or habitual use of illicit drugs
6. Patients who are pregnant or breastfeeding
7. Patients unable to communicate in Japanese

18age old over
No limit

Both

Urological diseases for which robotic surgery is indicated

Anesthetic management
Intervention group (R group: robotic anesthesia group)
Under the supervision of an anesthesiologist, the administration of propofol, remifentanil, and rocuronium will be automatically controlled using AsisTIVA. If the attending anesthesiologist judges that patient safety may be compromised, or otherwise determines intraoperatively that automated control is inappropriate (e.g., inadequate monitoring or massive bleeding), anesthetic management will be switched to manual control.
Conventional group (C group: manual-control anesthesia group)
The doses of propofol, remifentanil, and rocuronium will be adjusted at the discretion of the attending anesthesiologist. However, rocuronium will be administered by continuous infusion according to the AsisTIVA algorithm, with a target train-of-four (TOF) count <=1.
Postoperative pain management
Postoperative pain management will be standardized in both groups as follows.
Fentanyl may be administered at the discretion of the attending anesthesiologist. Unless contraindicated, intravenous acetaminophen will be administered over at least 15 minutes at the time of wound closure at the maximum dose: 1,000 mg in total for patients weighing <=50 kg, or 15 mg/kg for patients weighing <50 kg.
For patients with an epidural catheter, the use of epidural anesthesia will be left to the discretion of the attending anesthesiologist. In patients not receiving epidural anesthesia, local infiltration anesthesia with ropivacaine or levobupivacaine will be performed at the time of wound closure.
Prevention of postoperative nausea and vomiting
Measures for the prevention of postoperative nausea and vomiting will be standardized in both groups as follows.
Unless contraindicated, 6.6 mg dexamethasone will be administered intravenously at the start of surgery. Similarly, 4 mg ondansetron will be administered intravenously at the time of wound closure. No alternative antiemetic agents will be specified when either drug is contraindicated.

Change in the total QoR-15J score from the preoperative baseline (at the time of anesthesia consent acquisition, up to the day before surgery) to POD1 (within 24 hours after the end of surgery)

1. Change in the total QoR-15J score at POD2, POD3, and POD7
(defined as within 48, 72, and 168 hours after the end of surgery, respectively; for patients discharged on or before POD6, the score obtained on the day of discharge will be used as the POD7 value)
2. Change in the total scores of each QoR-15J subscale (Part A and Part B) at POD1, POD2, POD3, and POD7
(defined as within 24, 48, 72, and 168 hours after the end of surgery, respectively; for patients discharged on or before POD6, the score obtained on the day of discharge will be used as the POD7 value)
3. Postoperative pain, assessed by the numeric rating scale (NRS) and postoperative analgesic consumption
4. Postoperative nausea and vomiting (PONV), assessed by occurrence within 24 hours after surgery and use of rescue antiemetics
5. Length of hospital stay
6. Completion rate of automated control in the R group
7. Total medical cost
8. Adverse events98. Device deficiencies

Kyoto University Certified Review Board
53 Shogoin-kawahara-cho, Sakyo-ku, Kyoto

+81-75-366-7618

ethcom@kuhp.kyoto-u.ac.jp
Approval

July. 06, 2026

none

History of Changes

No Publication date
2 Aug. 21, 2026 (this page) Changes
1 July. 22, 2026 Detail