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Continuous Infusion of Remidazolam for Colonoscopic Polypectomy in Elderly Patients

T

Tongji Hospital

Status

Completed

Conditions

Colon Disease

Treatments

Drug: Remimazolam
Drug: Propofol

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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

Full 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.

Enrollment

114 patients

Sex

All

Ages

60 to 80 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

114 participants in 3 patient groups

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

Trial contacts and locations

1

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Central trial contact

mujun Chang, Dr.

Data sourced from clinicaltrials.gov

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