Comparison of Remimazolam-based MAC With Inhalation General Anesthesia Under the Guidance of an ANI Monitor During TURB
- Conditions
- Patients Undergoing Transurethral Resection of Bladder
- Interventions
- Drug: general anesthesia with sevoflurane
- Registration Number
- NCT06217055
- Lead Sponsor
- Yonsei University
- 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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 46
patients undergoing transurethral bladder resection
- ASA class 4
- emergency surgery
- history of hypersensitivity to sevoflurane, propofol and remimazolam
- galactose intolerance
- patient refusal
- patients in whom muscular relaxation are needed.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description inhalation general anesthesia group general anesthesia with sevoflurane general anesthesia with sevoflurane remimazolam based MAC group remimazolam based MAC remimazolam based monitored anesthesia care
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method incidence of hypotension At the end of surgery hypotension: baseline BP reduction (20%)
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)
surgery cost and anesthesia cost 1 month after surgery surgery cost and anesthesia cost: insured cost and non-insured cost
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.
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.
incidence of hypoxemia At the end of surgery hypoxemia : unresponsive to a jaw thrust maneuver and SPO2 \<92%
Trial Locations
- Locations (1)
Yonsei university college of medicine
🇰🇷Seoul, Korea, Republic of