Patients Undergoing Transurethral Resection of Bladder
Conditions
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.
Interventions
DRUGremimazolam based MAC
The surgery will be performed under monitored anesthesia care by maintaining spontaneous breathing using remimazolam.
DRUGgeneral anesthesia with sevoflurane
The surgery will be performed under mechanical ventilation with inhalation general anesthesia
Sponsors
Yonsei University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| anesthesia time excluding operation time | 0-1 hour after the end of surgery (Time point at which patient exit the operating room) | anesthesia time excluding operation time |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| surgeon's satisfaction score | At the end of surgery | surgeon's satisfaction score: very poor (1)/ poor (2)/ satisfactory (3)/ good (4)/excellent (5) |
| patient's satisfaction score | 0-2 hour after surgery (Time points at patient discharge from recovery room) | patient's satisfaction score: very poor (1)/ poor (2)/ satisfactory (3)/ good (4)/excellent (5) |
| pain score | 0-2 hour after surgery (Time points at patient discharge from recovery room), and 6 hour after surgery | pain score : NRS 0-10 The numerical rating scale requires the patient to rate their pain or nausea/vomiting on a defined scale. Numerical rating scale (NRS) is the simplest and most commonly used scale. The numerical scale is most commonly 0 to 10, with 0 being no pain or no nausea/vomiting and 10 being the worst pain or nausea/vomiting imaginable. |
| surgery cost and anesthesia cost | 1 month after surgery | surgery cost and anesthesia cost: insured cost and non-insured cost |
| incidence of hypotension | At the end of surgery | hypotension: baseline BP reduction (20%) |
| incidence of hypoxemia | At the end of surgery | hypoxemia : unresponsive to a jaw thrust maneuver and SPO2 \<92% |
| PONV score | 0-2 hour after surgery (Time points at patient discharge from recovery room), and 6 hour after surgery | PONV was defined as nausea or vomiting score. |
Countries
South Korea
Contacts
Primary ContactJin Ha Park
Outcome results
None listed