Continuous Infusion of Remidazolam for Colonoscopic Polypectomy in Elderly Patients

NCT05801757 | Completed

• 1 other identifier: CIRC
• Study Type: interventional
• Target: 114
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Colon Disease

Keywords

colonoscopic polypectomy; elderly patients

Outcome Measures

Primary Outcomes (1)

• Sedation success rate

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

  1 day

Secondary Outcomes (4)

• Intraoperative time record

  Intraoperative

• Drug usage

  1 day

• The incidence of adverse reactions during surgery

  1 day

• Incidence of postoperative adverse reactions

  24 hours after surgery

Study Arms (3)

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

Remimazolam DRUG

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

Also known as: Remimazolam besylate

R1 group; R2 group

Propofol DRUG

propofol 2-3mg/kg/h

Also known as: Diprivan

Propofol group

Eligibility Criteria

• Age: 60 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tongji Hospital: lead

Study Sites (1)

Tongji Hospital

Wuhan, Hubei, 430000, China

Location

MeSH Terms

Conditions

Colonic Diseases

Interventions

remimazolam; Propofol

Condition Hierarchy (Ancestors)

Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• aihua Du, Dr.

  Tongji Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Single blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Model Details: Single blind, prospective, randomized controlled study

Study Record Dates

• First Submitted: March 26, 2023
• First Posted: April 6, 2023
• Study Start: May 1, 2023
• Primary Completion: April 30, 2024
• Study Completion: April 30, 2024
• Last Updated: August 13, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)