Back to resultsContinuous Infusion of Remidazolam for Colonoscopic Polypectomy in Elderly Patients
Primary Purpose
Colon Disease
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Remimazolam
Propofol
Sponsored by
About this trial
This is an interventional treatment trial for Colon Disease focused on measuring colonoscopic polypectomy, elderly patients
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.
Sites / Locations
- Tongji HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Experimental
Experimental
Arm Label
Propofol group
R1 group
R2 group
Arm Description
propofol 2-3mg/kg/h
remimazolam 0.5mg/kg/h
remimazolam 0.75mg/kg/h
Outcomes
Primary Outcome Measures
Sedation success rate
Evaluating the success rate of sedation using the modified MOAA/S scoring table
Secondary Outcome Measures
Intraoperative time record
Anesthesia time; Operation time; Wake up time; PACU time
Drug usage
doses of propofol,remimazolam and other drugs used
The incidence of adverse reactions during surgery
includes: body movements, hypoxemia, hypotension, bradycardia; Intraoperative awareness
Incidence of postoperative adverse reactions
Postoperative nausea and vomiting, postoperative pain, hypotension, bradycardia, dizziness
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05801757
Brief Title
Continuous Infusion of Remidazolam for Colonoscopic Polypectomy in Elderly Patients
Official Title
Sedative Effect of Remidazolam Besylate Continuous Pump Infusion for Colonoscopic Polypectomy in Elderly Patients
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 1, 2023 (Actual)
Primary Completion Date
April 30, 2024 (Anticipated)
Study Completion Date
April 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tongji Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colon Disease
Keywords
colonoscopic polypectomy, elderly patients
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Single blind, prospective, randomized controlled study
Masking
ParticipantCare ProviderOutcomes Assessor
Masking Description
Single blind
Allocation
Randomized
Enrollment
114 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Propofol group
Arm Type
Active Comparator
Arm Description
propofol 2-3mg/kg/h
Arm Title
R1 group
Arm Type
Experimental
Arm Description
remimazolam 0.5mg/kg/h
Arm Title
R2 group
Arm Type
Experimental
Arm Description
remimazolam 0.75mg/kg/h
Intervention Type
Drug
Intervention Name(s)
Remimazolam
Other Intervention Name(s)
Remimazolam besylate
Intervention Description
Using two different doses of remidazolam for continuous pumping to maintain anesthetic effect
Intervention Type
Drug
Intervention Name(s)
Propofol
Other Intervention Name(s)
Diprivan
Intervention Description
propofol 2-3mg/kg/h
Primary Outcome Measure Information:
Title
Sedation success rate
Description
Evaluating the success rate of sedation using the modified MOAA/S scoring table
Time Frame
1 day
Secondary Outcome Measure Information:
Title
Intraoperative time record
Description
Anesthesia time; Operation time; Wake up time; PACU time
Time Frame
Intraoperative
Title
Drug usage
Description
doses of propofol,remimazolam and other drugs used
Time Frame
1 day
Title
The incidence of adverse reactions during surgery
Description
includes: body movements, hypoxemia, hypotension, bradycardia; Intraoperative awareness
Time Frame
1 day
Title
Incidence of postoperative adverse reactions
Description
Postoperative nausea and vomiting, postoperative pain, hypotension, bradycardia, dizziness
Time Frame
24 hours after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
mujun Chang, Dr.
Phone
86-27-83663625
Email
changmujun@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
aihua Du, Dr.
Organizational Affiliation
Tongji Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Tongji Hospital
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
aijun xu, Dr.
Phone
27-83663173
Email
ajxu@tjh.tjmu.edu.cn
First Name & Middle Initial & Last Name & Degree
Yueyang Xin, Dr.
Phone
027-83663173
Email
king000999@163.com
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
You can request it from the main researcher
Learn more about this trial
Continuous Infusion of Remidazolam for Colonoscopic Polypectomy in Elderly Patients
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