Clinical trial NCT06217055: Comparison of Remimazolam-based MAC With Inhalation General Anesthesia Under the Guidance of an ANI Monitor During TURB
Official title: Comparison of Remimazolam-based Monitored Anesthesia Care With Inhalation General Anesthesia Under the Guidance of an ANI Monitor During TURB: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Patients Undergoing Transurethral Resection of Bladder
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2024-01-22
Enrollment: 46
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In patients undergoing transurethral resection of bladder, the effect of remimazolam-based monitored anesthesia care (MAC) and inhalational general anesthesia will be compared under guidance by analgesia nociception index (ANI) monitoring. Anesthesia time, operation time, anesthesia time excluding operation time and total dose of opioid will be compared.

Detailed description: In remimazolam-based MAC group, anesthesia will be induced with remimazolam and spontaneous breathing will be maintained. The dose of remimazolam and remifentanil will be adjusted according to the patient state index (PSI) and the analgesia nociception index(ANI).

In inhalation general anesthesia group, anesthesia will be induced with propofol and rocuronium and maintained with sevoflurane and remifentanil. Mechanical ventilation will be maintained by inserting laryngeal mask airway (LMA) or endotracheal tube. The doses of sevoflurane and remifentanil will be adjusted according to the patient state index (PSI) and the analgesia nociception index(ANI).

Surgery cost, anesthesia cost, patient and surgeon's satisfaction score, pain score, PONV score and the incidence of hypotension and hypoxemia will be compared.

Eligibility criteria: Inclusion Criteria:

patients undergoing transurethral bladder resection

Exclusion Criteria:

* ASA class 4
* emergency surgery
* history of hypersensitivity to sevoflurane, propofol and remimazolam
* galactose intolerance
* patient refusal
* patients in whom muscular relaxation are needed.

Primary outcomes:
measure: anesthesia time excluding operation time
timeFrame: 0-1 hour after the end of surgery (Time point at which patient exit the operating room)
Secondary outcomes:
measure: surgery cost and anesthesia cost
timeFrame: 1 month after surgery
measure: surgeon's satisfaction score
timeFrame: At the end of surgery
measure: patient's satisfaction score
timeFrame: 0-2 hour after surgery (Time points at patient discharge from recovery room)
measure: pain score
timeFrame: 0-2 hour after surgery (Time points at patient discharge from recovery room), and 6 hour after surgery
measure: PONV score
timeFrame: 0-2 hour after surgery (Time points at patient discharge from recovery room), and 6 hour after surgery
measure: incidence of hypotension
timeFrame: At the end of surgery
measure: incidence of hypoxemia
timeFrame: At the end of surgery
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Yonsei university college of medicine
Study officials:
References: