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

Comparison of Remimazolam-based Monitored Anesthesia Care With Inhalation General Anesthesia Under the Guidance of an ANI Monitor During TURB: a Randomized Controlled Trial

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Patients Undergoing Transurethral Resection of Bladder
• Intervention / Treatment: Drug: remimazolam based MAC; Drug: general anesthesia with sevoflurane

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.

• Study Type: Interventional
• Enrollment (Estimated): 46
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jin Ha Park; Phone Number: 82-2-2228-2420; Email: realsummer@yuhs.ac

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Yonsei University College of Medicine
    • Contact: Jin Ha Park; Phone Number: 82-2-2228-2420; Email: realsummer@yuhs.ac

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: remimazolam based MAC group; remimazolam based monitored anesthesia care	Drug: remimazolam based MAC; The surgery will be performed under monitored anesthesia care by maintaining spontaneous breathing using remimazolam.
Active Comparator: inhalation general anesthesia group; general anesthesia with sevoflurane	Drug: general anesthesia with sevoflurane; The surgery will be performed under mechanical ventilation with inhalation general anesthesia

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
anesthesia time excluding operation time	anesthesia time excluding operation time	0-1 hour after the end of surgery (Time point at which patient exit the operating room)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
surgery cost and anesthesia cost	surgery cost and anesthesia cost: insured cost and non-insured cost	1 month after surgery
surgeon's satisfaction score	surgeon's satisfaction score: very poor (1)/ poor (2)/ satisfactory (3)/ good (4)/excellent (5)	At the end of surgery
patient's satisfaction score	patient's satisfaction score: very poor (1)/ poor (2)/ satisfactory (3)/ good (4)/excellent (5)	0-2 hour after surgery (Time points at patient discharge from recovery room)
pain score	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.	0-2 hour after surgery (Time points at patient discharge from recovery room), and 6 hour after surgery
PONV score	PONV was defined as nausea or vomiting score.	0-2 hour after surgery (Time points at patient discharge from recovery room), and 6 hour after surgery
incidence of hypotension	hypotension: baseline BP reduction (20%)	At the end of surgery
incidence of hypoxemia	hypoxemia : unresponsive to a jaw thrust maneuver and SPO2 <92%	At the end of surgery

Collaborators and Investigators

• Sponsor: Yonsei University

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2024
• Primary Completion (Estimated): October 1, 2024
• Study Completion (Estimated): October 1, 2024

Study Registration Dates

• First Submitted: November 22, 2023
• First Submitted That Met QC Criteria: January 17, 2024
• First Posted (Actual): January 22, 2024

Study Record Updates

• Last Update Posted (Actual): January 22, 2024
• Last Update Submitted That Met QC Criteria: January 17, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Respiration Disorders; Respiratory Aspiration; Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics, General; Anesthetics; Platelet Aggregation Inhibitors; Anesthetics, Inhalation; Sevoflurane
• Other Study ID Numbers: 4-2023-1206

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No