Comparison of Remimazolam-based MAC With Inhalation General Anesthesia Under the Guidance of an ANI Monitor During TURB

Yonsei University

Status: Not yet enrolling

Conditions: Patients Undergoing Transurethral Resection of Bladder

Treatments: Drug: general anesthesia with sevoflurane; Drug: remimazolam based MAC

Study type: Interventional

Funder types: Other

Identifiers

NCT06217055

4-2023-1206

Details and patient eligibility

About

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.

Full 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.

Enrollment: 46 estimated patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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46 participants in 2 patient groups

remimazolam based MAC group

Experimental group

Description:

remimazolam based monitored anesthesia care

Treatment:

Drug: remimazolam based MAC

inhalation general anesthesia group

Active Comparator group

Description:

general anesthesia with sevoflurane

Treatment:

Drug: general anesthesia with sevoflurane