Continuous Infusion of Remidazolam for Colonoscopic Polyp... | NCT05801757

Studies
Continuous Infusion of Remidazolam for Colonoscopic Polypectomy in Elderly Patients

NCT05801757

Sponsor

Tongji Hospital

Status

Completed

Last Update Posted

Aug 13, 2024Actual

Enrollment

114Actual

Phase

Not Applicable

Conditions

Colon Disease

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

Aug 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 1, 2023Actual

Primary Completion Date

Apr 30, 2024Actual

Completion Date

Apr 30, 2024Actual

First Submitted Date

Mar 26, 2023

First Submission Date that Met QC Criteria

Apr 5, 2023

First Posted Date

Apr 6, 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

Aug 12, 2024

Last Update Posted Date

Aug 13, 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

To observe the sedative effect of continuous infusion of remidazolam in elderly patients undergoing colonoscopic polypectomy.

Detailed Description

To observe the sedative effect of continuous infusion of remidazolam in elderly patients undergoing colonoscopic polypectomy, and to screen the optimal dose of remidazolam, in order to provide a more reasonable and safe sedative and analgesic drug regimen for elderly outpatients undergoing colonoscopic polypectomy.

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

114Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Propofol group	Active Comparator	propofol 2-3mg/kg/h	Drug: Propofol
R1 group	Experimental	remimazolam 0.5mg/kg/h	Drug: Remimazolam
R2 group	Experimental	remimazolam 0.75mg/kg/h	Drug: Remimazolam

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Remimazolam	Drug	Using two different doses of remidazolam for continuous pumping to maintain anesthetic effect	R1 group R2 group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Sedation success rate	Evaluating the success rate of sedation using the modified MOAA/S scoring table	1 day

Secondary Outcomes

Measure	Description	Time Frame
Intraoperative time record	Anesthesia time; Operation time; Wake up time; PACU time	Intraoperative
Drug usage	doses of propofol,remimazolam and other drugs used

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age 60-80 years old;
ASA Level I - III;
Operation time: 15min~1h;
BMI18.0-29.9；

Exclusion Criteria:

Emergency surgery;
Patients with high risk of gastric satiety and reflux aspiration;
Allergies to benzodiazepines and opioids;
Those who have taken sedative, analgesic, or antidepressant drugs within 24 hours;
Abnormal liver and kidney function;
Previous drug use history;
Recently participated in other clinical studies;
Patients who cannot cooperate with communication.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

60 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
aihua Du, Dr.	Tongji Hospital	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Tongji Hospital		Wuhan	Hubei	430000	China

IPD Sharing Statement Module

Plan to Share IPD

Description

You can request it from the main researcher

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D003108	Colonic Diseases

Ancestor Terms

ID	Term
D007410	Intestinal Diseases
D005767	Gastrointestinal Diseases
D004066	Digestive System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C522201	remimazolam
D015742	Propofol

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided