Remimazolam Versus Propopol Based Total Intravenous Anesthesia for Breast Surgery

Hypotension Clinical Trial

Official title:

Comparison Between Remimazolam Versus Propopol Based Total Intravenous Anesthesia for Breast Surgery : A Randomized Controlled Trial

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT05375747
• Other study ID #: 2112-150-1286
• Status: Withdrawn
• Phase: N/A
• Start date: December 1, 2022
• Est. completion date: August 31, 2023

Study information

• Verified date: January 2023
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Comparison of the incidence of hypotension under remimazolam and propofol-based anesthesia in patients undergoing breast surgery under general anesthesia

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: August 31, 2023
• Est. primary completion date: July 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hypotension

Intervention

Drug:
• Remimazolam
For induction and maintenance of anesthesia, total intravenous anesthesia is performed using continuous intravenous infusion of remimazolam and remifentanil.
• Propofol
For induction and maintenance of anesthesia, total intravenous anesthesia is performed using continuous intravenous infusion of propofol and remifentanil.

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hypotension incidence	Incidence of hypotension (MAP <65 mmHg) from induction of anesthesia to end of surgery	from induction of anesthesia to end of surgery
Secondary	Use of vasopressor	Proportion of patients using vasopressors due to hypotension from induction of anesthesia to completion of surgery	from induction of anesthesia to end of surgery
Secondary	Number of occurrences of hypotension during surgery	Number of occurrences of hypotension during surgery	from induction of anesthesia to end of surgery
Secondary	Type of vasopressor used	Type of vasopressor used	from induction of anesthesia to end of surgery
Secondary	Total dose of vasopressor used	Total dose of vasopressor used	from induction of anesthesia to end of surgery
Secondary	Blood pressure	Blood pressure during operation, noninvasive blood pressure is measured at lower leg	from induction of anesthesia to end of surgery
Secondary	Heart rate	Heart rate during operation	from induction of anesthesia to end of surgery
Secondary	Saturation of percutaneous oxygen (SpO2)	Saturation of percutaneous oxygen (SpO2) during operation	from induction of anesthesia to end of surgery
Secondary	Patient State Index (PSi)	Patient State Index (PSi) during operation	from induction of anesthesia to end of surgery
Secondary	Incidence of bradycardia	Incidence of bradycardia during operation, bradycardia is defined as heart rate less than 50	from induction of anesthesia to end of surgery
Secondary	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	At the start of induction of general anesthesia
Secondary	Incidence of intraoperative awareness	Incedence of intraoperative awareness during operation	from induction of anesthesia to end of surgery
Secondary	Incidence of intraoperative body movement	Incidence of intraoperative body movement during operation	from induction of anesthesia to end of surgery
Secondary	Incidence of use of rescue sedative agents	Incidence of use of any kinds of rescue sedative agents	from induction of anesthesia to end of surgery
Secondary	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	from induction of anesthesia to loss of consciousness
Secondary	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	from end of administration of sedative to eye opening
Secondary	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	from end of administration of sedative to response to verbal command
Secondary	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	from end of administration of sedative to supraglottic airway removal
Secondary	Duration of post anesthesia care unit stay	Duration of post anesthesia care unit stay	From entering post anesthesia care unit until leaving, post-operatively 1 hour average
Secondary	Total analgesic consumption for 24 hours after surgery	Total analgesic consumption for 24 hours after surgery	For 24 hours after the end of surgery
Secondary	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	Immediate after end of surgery
Secondary	Incidence of nausea and vomiting within 24 hours after surgery	Incidence of nausea and vomiting within 24 hours after surgery	within 24 hours after surgery
Secondary	Severity of nausea and vomiting within 24 hours after surgery	Severity of nausea and vomiting within 24 hours after surgery: none,. mild, moderate, severe	within 24 hours after surgery
Secondary	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	During the day of surgery
Secondary	Patient satisfaction with anesthesia	Patient satisfaction with anesthesia, Score out of 10, the higher the number, the better the quality of sleep	The day of operation
Secondary	Hospital length of stay	Hospital length of stay	From administration to discharge, average 4 days
Secondary	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	24 hours after surgery