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Completed

NCT Number: NCT05801757

Continuous Infusion of Remidazolam for Colonoscopic Polypectomy in Elderly Patients

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

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Key information

Conditions

Colon Disease Colonic Diseases Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases

Age range

60 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tongji Hospital

Wuhan, Hubei, 430000, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Remimazolam

Drug

Using two different doses of remidazolam for continuous pumping to maintain anesthetic effect

Other names: Remimazolam besylate

Propofol

Drug

propofol 2-3mg/kg/h

Other names: Diprivan

Primary outcomes

  1. Sedation success rate

    Time frame: 1 day

    Evaluating the success rate of sedation using the modified MOAA/S scoring table

Secondary outcomes

  1. Intraoperative time record

    Time frame: Intraoperative

    Anesthesia time; Operation time; Wake up time; PACU time

  2. Drug usage

    Time frame: 1 day

    doses of propofol,remimazolam and other drugs used

  3. The incidence of adverse reactions during surgery

    Time frame: 1 day

    includes: body movements, hypoxemia, hypotension, bradycardia; Intraoperative awareness

  4. Incidence of postoperative adverse reactions

    Time frame: 24 hours after surgery

    Postoperative nausea and vomiting, postoperative pain, hypotension, bradycardia, dizziness

Sponsors and collaborators

Lead sponsor

Tongji Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Apr 6, 2023
Registry last updated
Aug 13, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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