Effects of Remimazolam and Propofol on Anesthesia Induction | NCT06009055

Studies
Effects of Remimazolam and Propofol on Anesthesia Induction

NCT06009055

Sponsor

Zheng Guo

Status

Unknown status

Last Update Posted

Jan 25, 2024Actual

Enrollment

80Estimated

Phase

Not Applicable

Conditions

Diabetes

Interventions

Remimazolam
Propofol

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2024

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 17, 2023Actual

Primary Completion Date

Nov 30, 2024Estimated

Completion Date

Dec 31, 2024Estimated

First Submitted Date

Feb 17, 2023

First Submission Date that Met QC Criteria

Aug 23, 2023

First Posted Date

Aug 24, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 24, 2024

Last Update Posted Date

Jan 25, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The patients with diabetes who underwent laparoscopic cholecystectomy in the general surgery department of the Second Hospital of Shanxi Medical University were selected. The patients who were induced by remimazolam were included in the experimental group, and the patients who were induced by propofol were included in the control group. All the selected patients had no intimate relationship. The differences of blood pressure, heart rate and heart rate variability (HRV) between the experimental group and the control group were observed. According to the literature, it is speculated that the changes of blood pressure, heart rate and HRV indexes in the experimental group are smaller than those in the control group, and the difference is statistically significant.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

80Estimated

Label	Type	Description	Intervention Names
Remimazolam group	Experimental		Drug: Remimazolam
Propofol group	Active Comparator		Drug: Propofol

Name	Type	Description	Arm Group Labels	Other Names
Remimazolam	Drug	0.3mg/kg，injection completed in 30 seconds	Remimazolam group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
systolic pressure （SBP）	Changes in systolic blood pressure	24 hours
diastolic pressure（DBP）	change of diastolic blood pressure	24 hours
heart rate	change of heart rate	24 hours
Heart rate variability（HRV）	Changes of various indicators of heart rate variability	24 hours

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Diagnosed as type 2 diabetes according to the "Chinese Guidelines for the Prevention and Treatment of Type 2 diabetes 2020"
ASA II or III

Exclusion Criteria:

People who are allergic to Remimazolam
It is estimated that patients with difficulty in tracheal intubation (poor head and neck mobility, history of airway surgery, history of OSAHS, nail to chin distance<6cm, Malampati grade 3 and above, mouth opening<2.5cm, obesity (BMI>30kg · m-2), etc
Hypertension (clinically diagnosed as hypertension)
Patients with coronary heart disease (with typical symptoms of angina pectoris and exclusion of aortic valve disease, clear history of old myocardial infarction, clear history of acute myocardial infarction, coronary stenosis greater than or equal to 70% found by CAG)
Patients with arrhythmia, heart failure, renal failure, and recently taking cardiovascular active drugs
Endocrine diseases such as hyperthyroidism and pheochromocytoma that may affect the level of body hemodynamics
Ketoacidosis and lactic acidosis
Patients with long-term use of sedatives or antidepressants or a history of alcoholism or drug dependence
Asthma or reactive airway disease
Patients with myasthenia gravis and cognitive dysfunction cannot cooperate with this study

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

30 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
econd of Shanxi Medical University	Recruiting	Taiyuan	Shanxi	030001	China

Condition Browse Module

MeSH Terms

ID	Term
D003920	Diabetes Mellitus

Ancestor Terms

ID	Term
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D004700	Endocrine System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

ID	Term
D010636	Phenols
D001555	Benzene Derivatives
D006841	Hydrocarbons, Aromatic
D006844	Hydrocarbons, Cyclic