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Remimazolam Versus Propopol Based Total Intravenous Anesthesia for Breast Surgery

Primary Purpose

Hypotension

Status
Withdrawn
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Remimazolam
Propofol
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypotension

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Adult patients over the age of 19 undergoing elective breast cancer surgery under general anesthesia at Seoul National University Hospital

Exclusion Criteria:

  • patients with acute narrow-angle glaucoma/ shock or coma/ acute alcohol poisoning/ sleep apnea/ alcohol or drug dependency/ severe or acute respiratory failure/ galactose intolerance/ Lapp lactase deficiency/ glucose galactose malabsorption/ severe hypersensitivity to dextran.
  • Patients with myasthenia gravis/ pulmonary heart disease/ chronic obstructive pulmonary disease/ bronchial asthma
  • Patients with cardiovascular diseases such as ischemic heart disease/ coronary artery disease/ angina pectoris/ myocardial infarction/ atherosclerosis/ arrhythmia/ cerebrovascular disease/ and stroke
  • Patients with chronic renal failure
  • Patients with severe hepatic impairment (Child Pugh class C)
  • Patients with American Society of Anesthesiology score III or higher
  • Patients with hypersensitivity to propofol and soy or peanuts
  • Epilepsy patients
  • Patient with fat metabolism abnormality
  • Patients with high intracranial pressure
  • Pregnant woman
  • Patients unable to use supraglottic airway due to poor dental condition
  • In cases that the researcher judges to be unsuitable for this clinical trial

Sites / Locations

  • Seoul National University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Remimazolam based total intravenous anesthesia

Propofol based total intravenous anesthesia

Arm Description

For induction and maintenance of anesthesia, total intravenous anesthesia is performed using continuous intravenous infusion of remimazolam and remifentanil.

For induction and maintenance of anesthesia, total intravenous anesthesia is performed using continuous intravenous infusion of propofol and remifentanil.

Outcomes

Primary Outcome Measures

Hypotension incidence
Incidence of hypotension (MAP <65 mmHg) from induction of anesthesia to end of surgery

Secondary Outcome Measures

Use of vasopressor
Proportion of patients using vasopressors due to hypotension from induction of anesthesia to completion of surgery
Number of occurrences of hypotension during surgery
Number of occurrences of hypotension during surgery
Type of vasopressor used
Type of vasopressor used
Total dose of vasopressor used
Total dose of vasopressor used
Blood pressure
Blood pressure during operation, noninvasive blood pressure is measured at lower leg
Heart rate
Heart rate during operation
Saturation of percutaneous oxygen (SpO2)
Saturation of percutaneous oxygen (SpO2) during operation
Patient State Index (PSi)
Patient State Index (PSi) during operation
Incidence of bradycardia
Incidence of bradycardia during operation, bradycardia is defined as heart rate less than 50
Severity of injection pain
Severity of injection pain of sedative(propofol or remimazolam depending on group assignment) during induction of anethesia: none/ mild/ moderate/ severe
Incidence of intraoperative awareness
Incedence of intraoperative awareness during operation
Incidence of intraoperative body movement
Incidence of intraoperative body movement during operation
Incidence of use of rescue sedative agents
Incidence of use of any kinds of rescue sedative agents
T ime from start of administration of sedative drug to loss of consciousness
T ime from start of administration of sedative drug to loss of consciousness
Time from the end of administration of sedative to eye opening
Time from the end of administration of sedative(propofol or remimazolam depending on group assignment) to eye opening
Time from the end of administration of sedative to response to verbal command
Time from the end of administration of sedative(propofol or remimazolam depending on group assignment) to response to verbal command
Time from the end of administration of sedative to supraglottic airway removal
Time from the end of administration of sedative(propofol or remimazolam depending on group assignment) to supraglottic airway removal
Duration of post anesthesia care unit stay
Duration of post anesthesia care unit stay
Total analgesic consumption for 24 hours after surgery
Total analgesic consumption for 24 hours after surgery
Numeric rating scale score in the recovery room immediately after surgery
Numeric rating scale score in the recovery room immediately after surgery, Numeric rating scale: 0 points for no pain, 10 points for the worst pain imaginable / The higher the number, the more severe the pain
Incidence of nausea and vomiting within 24 hours after surgery
Incidence of nausea and vomiting within 24 hours after surgery
Severity of nausea and vomiting within 24 hours after surgery
Severity of nausea and vomiting within 24 hours after surgery: none,. mild, moderate, severe
Subjective sleep quality on the day of surgery
Subjective sleep quality on the day of surgery, Score out of 10, the higher the number, the better the quality of sleep
Patient satisfaction with anesthesia
Patient satisfaction with anesthesia, Score out of 10, the higher the number, the better the quality of sleep
Hospital length of stay
Hospital length of stay
15 item Quality of Recovery
15 item Quality of Recovery: 15-item questionnaire about the degree of recovery after surgery, 10 points per question, total 150 points

Full Information

First Posted
May 6, 2022
Last Updated
January 13, 2023
Sponsor
Seoul National University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05375747
Brief Title
Remimazolam Versus Propopol Based Total Intravenous Anesthesia for Breast Surgery
Official Title
Comparison Between Remimazolam Versus Propopol Based Total Intravenous Anesthesia for Breast Surgery : A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Withdrawn
Why Stopped
Unable to recruit participants due to hospital conditions
Study Start Date
December 1, 2022 (Anticipated)
Primary Completion Date
July 1, 2023 (Anticipated)
Study Completion Date
August 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Comparison of the incidence of hypotension under remimazolam and propofol-based anesthesia in patients undergoing breast surgery under general anesthesia
Detailed Description
The purpose of this study was to investigate whether remimazolam-based general anesthesia could reduce the incidence of hypotension in patients undergoing breast surgery under general anesthesia compared to propofol-based general anesthesia. The purpose of this study is to establish and test the hypothesis that the incidence of hypotension under general anesthesia based on remimazolam will be less than that of propofol based general anesthesia. In addition, this study compares the proportion of patients who require a vasopressor, the time taken for anesthesia induction, the time to recover from anesthesia, postoperative pain, the incidence of postoperative nausea and vomiting, the quality of postoperative recovery, and patient satisfaction.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypotension

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Remimazolam based total intravenous anesthesia
Arm Type
Experimental
Arm Description
For induction and maintenance of anesthesia, total intravenous anesthesia is performed using continuous intravenous infusion of remimazolam and remifentanil.
Arm Title
Propofol based total intravenous anesthesia
Arm Type
Active Comparator
Arm Description
For induction and maintenance of anesthesia, total intravenous anesthesia is performed using continuous intravenous infusion of propofol and remifentanil.
Intervention Type
Drug
Intervention Name(s)
Remimazolam
Intervention Description
For induction and maintenance of anesthesia, total intravenous anesthesia is performed using continuous intravenous infusion of remimazolam and remifentanil.
Intervention Type
Drug
Intervention Name(s)
Propofol
Intervention Description
For induction and maintenance of anesthesia, total intravenous anesthesia is performed using continuous intravenous infusion of propofol and remifentanil.
Primary Outcome Measure Information:
Title
Hypotension incidence
Description
Incidence of hypotension (MAP <65 mmHg) from induction of anesthesia to end of surgery
Time Frame
from induction of anesthesia to end of surgery
Secondary Outcome Measure Information:
Title
Use of vasopressor
Description
Proportion of patients using vasopressors due to hypotension from induction of anesthesia to completion of surgery
Time Frame
from induction of anesthesia to end of surgery
Title
Number of occurrences of hypotension during surgery
Description
Number of occurrences of hypotension during surgery
Time Frame
from induction of anesthesia to end of surgery
Title
Type of vasopressor used
Description
Type of vasopressor used
Time Frame
from induction of anesthesia to end of surgery
Title
Total dose of vasopressor used
Description
Total dose of vasopressor used
Time Frame
from induction of anesthesia to end of surgery
Title
Blood pressure
Description
Blood pressure during operation, noninvasive blood pressure is measured at lower leg
Time Frame
from induction of anesthesia to end of surgery
Title
Heart rate
Description
Heart rate during operation
Time Frame
from induction of anesthesia to end of surgery
Title
Saturation of percutaneous oxygen (SpO2)
Description
Saturation of percutaneous oxygen (SpO2) during operation
Time Frame
from induction of anesthesia to end of surgery
Title
Patient State Index (PSi)
Description
Patient State Index (PSi) during operation
Time Frame
from induction of anesthesia to end of surgery
Title
Incidence of bradycardia
Description
Incidence of bradycardia during operation, bradycardia is defined as heart rate less than 50
Time Frame
from induction of anesthesia to end of surgery
Title
Severity of injection pain
Description
Severity of injection pain of sedative(propofol or remimazolam depending on group assignment) during induction of anethesia: none/ mild/ moderate/ severe
Time Frame
At the start of induction of general anesthesia
Title
Incidence of intraoperative awareness
Description
Incedence of intraoperative awareness during operation
Time Frame
from induction of anesthesia to end of surgery
Title
Incidence of intraoperative body movement
Description
Incidence of intraoperative body movement during operation
Time Frame
from induction of anesthesia to end of surgery
Title
Incidence of use of rescue sedative agents
Description
Incidence of use of any kinds of rescue sedative agents
Time Frame
from induction of anesthesia to end of surgery
Title
T ime from start of administration of sedative drug to loss of consciousness
Description
T ime from start of administration of sedative drug to loss of consciousness
Time Frame
from induction of anesthesia to loss of consciousness
Title
Time from the end of administration of sedative to eye opening
Description
Time from the end of administration of sedative(propofol or remimazolam depending on group assignment) to eye opening
Time Frame
from end of administration of sedative to eye opening
Title
Time from the end of administration of sedative to response to verbal command
Description
Time from the end of administration of sedative(propofol or remimazolam depending on group assignment) to response to verbal command
Time Frame
from end of administration of sedative to response to verbal command
Title
Time from the end of administration of sedative to supraglottic airway removal
Description
Time from the end of administration of sedative(propofol or remimazolam depending on group assignment) to supraglottic airway removal
Time Frame
from end of administration of sedative to supraglottic airway removal
Title
Duration of post anesthesia care unit stay
Description
Duration of post anesthesia care unit stay
Time Frame
From entering post anesthesia care unit until leaving, post-operatively 1 hour average
Title
Total analgesic consumption for 24 hours after surgery
Description
Total analgesic consumption for 24 hours after surgery
Time Frame
For 24 hours after the end of surgery
Title
Numeric rating scale score in the recovery room immediately after surgery
Description
Numeric rating scale score in the recovery room immediately after surgery, Numeric rating scale: 0 points for no pain, 10 points for the worst pain imaginable / The higher the number, the more severe the pain
Time Frame
Immediate after end of surgery
Title
Incidence of nausea and vomiting within 24 hours after surgery
Description
Incidence of nausea and vomiting within 24 hours after surgery
Time Frame
within 24 hours after surgery
Title
Severity of nausea and vomiting within 24 hours after surgery
Description
Severity of nausea and vomiting within 24 hours after surgery: none,. mild, moderate, severe
Time Frame
within 24 hours after surgery
Title
Subjective sleep quality on the day of surgery
Description
Subjective sleep quality on the day of surgery, Score out of 10, the higher the number, the better the quality of sleep
Time Frame
During the day of surgery
Title
Patient satisfaction with anesthesia
Description
Patient satisfaction with anesthesia, Score out of 10, the higher the number, the better the quality of sleep
Time Frame
The day of operation
Title
Hospital length of stay
Description
Hospital length of stay
Time Frame
From administration to discharge, average 4 days
Title
15 item Quality of Recovery
Description
15 item Quality of Recovery: 15-item questionnaire about the degree of recovery after surgery, 10 points per question, total 150 points
Time Frame
24 hours after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adult patients over the age of 19 undergoing elective breast cancer surgery under general anesthesia at Seoul National University Hospital Exclusion Criteria: patients with acute narrow-angle glaucoma/ shock or coma/ acute alcohol poisoning/ sleep apnea/ alcohol or drug dependency/ severe or acute respiratory failure/ galactose intolerance/ Lapp lactase deficiency/ glucose galactose malabsorption/ severe hypersensitivity to dextran. Patients with myasthenia gravis/ pulmonary heart disease/ chronic obstructive pulmonary disease/ bronchial asthma Patients with cardiovascular diseases such as ischemic heart disease/ coronary artery disease/ angina pectoris/ myocardial infarction/ atherosclerosis/ arrhythmia/ cerebrovascular disease/ and stroke Patients with chronic renal failure Patients with severe hepatic impairment (Child Pugh class C) Patients with American Society of Anesthesiology score III or higher Patients with hypersensitivity to propofol and soy or peanuts Epilepsy patients Patient with fat metabolism abnormality Patients with high intracranial pressure Pregnant woman Patients unable to use supraglottic airway due to poor dental condition In cases that the researcher judges to be unsuitable for this clinical trial
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Seokha Yoo
Organizational Affiliation
Seoul National University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of

12. IPD Sharing Statement

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Remimazolam Versus Propopol Based Total Intravenous Anesthesia for Breast Surgery

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