Continuous Infusion of Remidazolam for Colonoscopic Polypectomy in Elderly Patients

Colon Disease Clinical Trial

Official title:

Sedative Effect of Remidazolam Besylate Continuous Pump Infusion for Colonoscopic Polypectomy in Elderly Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05801757
• Other study ID #: CIRC
• Status: Recruiting
• Phase: N/A
• Start date: May 1, 2023
• Est. completion date: April 30, 2024

Study information

• Verified date: September 2023
• Source: Tongji Hospital
• Contact: mujun Chang, Dr.
• Phone: 86-27-83663625
• Email: changmujun[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 114
• Est. completion date: April 30, 2024
• Est. primary completion date: April 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Colon Disease
• Colonic Diseases

Intervention

Drug:
• Remimazolam
Using two different doses of remidazolam for continuous pumping to maintain anesthetic effect
• Propofol
propofol 2-3mg/kg/h

Locations

Country	Name	City	State
China	Tongji Hospital	Wuhan	Hubei

Sponsors (1)

Lead Sponsor	Collaborator
Tongji Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sedation success rate	Evaluating the success rate of sedation using the modified MOAA/S scoring table	1 day
Secondary	Intraoperative time record	Anesthesia time; Operation time; Wake up time; PACU time	Intraoperative
Secondary	Drug usage	doses of propofol,remimazolam and other drugs used	1 day
Secondary	The incidence of adverse reactions during surgery	includes: body movements, hypoxemia, hypotension, bradycardia; Intraoperative awareness	1 day
Secondary	Incidence of postoperative adverse reactions	Postoperative nausea and vomiting, postoperative pain, hypotension, bradycardia, dizziness	24 hours after surgery