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

NCT ID: NCT06217055

Last Updated: 2024-01-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

46 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-31

Study Completion Date

2024-10-31

Brief Summary

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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

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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.

Conditions

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Patients Undergoing Transurethral Resection of Bladder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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remimazolam based MAC group

remimazolam based monitored anesthesia care

Group Type EXPERIMENTAL

remimazolam based MAC

Intervention Type DRUG

The surgery will be performed under monitored anesthesia care by maintaining spontaneous breathing using remimazolam.

inhalation general anesthesia group

general anesthesia with sevoflurane

Group Type ACTIVE_COMPARATOR

general anesthesia with sevoflurane

Intervention Type DRUG

The surgery will be performed under mechanical ventilation with inhalation general anesthesia

Interventions

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remimazolam based MAC

The surgery will be performed under monitored anesthesia care by maintaining spontaneous breathing using remimazolam.

Intervention Type DRUG

general anesthesia with sevoflurane

The surgery will be performed under mechanical ventilation with inhalation general anesthesia

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Yonsei University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Yonsei university college of medicine

Seoul, , South Korea

Site Status

Countries

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South Korea

Central Contacts

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Jin Ha Park

Role: CONTACT

82-2-2228-2420

Facility Contacts

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Jin Ha Park

Role: primary

82-2-2228-2420

Other Identifiers

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4-2023-1206

Identifier Type: -

Identifier Source: org_study_id

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