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Effect of Midazolam Premedication on the Satisfaction Levels of Patients After Endoscopic Submucosal Dissection

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Yonsei University

Status

Completed

Conditions

Early Gastric Cancer
Gastric Adenoma

Treatments

Drug: No premedication
Drug: midazolam 0.02mg/kg

Study type

Interventional

Funder types

Other

Identifiers

NCT02504164
4-2014-0310

Details and patient eligibility

About

Endoscopic submucosal dissection is commonly performed under light to moderate sedation, and minimizing patient movement is of key importance for successful outcome. Propofol has widely replaced benzodiazepines as sedative drug of choice, and has been reported to enhance the quality of procedure in our past study. However, despite higher satisfaction scores of the endoscopists and faster post-procedural recovery, patient satisfaction scores were found to be higher in patients that received midazolam and meperidine instead of propofol and remifentanil. This seems to be due to the anterograde amnestic effects of midazolam rather than the quality of sedation itself. Investigator hypothesized that by premedicating the patient with low lose midazolam before receiving sedation for ESD with propofol and fentanyl, patient satisfaction would be enhanced without affecting endoscopic performance.

Enrollment

72 patients

Sex

All

Ages

19+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  1. Adult patients over the age of 19 diagnosed with early gastric cancer or gastric adenoma that are scheduled for endoscopic submucosal dissection
  2. American society of anesthesiologist physical status 1~3

Exclusion criteria

  1. Patient refusal
  2. Patients that received sedatives within 24 hours prior to endoscopic submucosal dissection
  3. History of gastrectomy or previous endoscopic submucosal dissection at same site
  4. Allergies to propofol or its ingredients, soybeans or peanuts
  5. Pregnant or breastfeeding patients
  6. Patients with severe debilitating underlying medical conditions
  7. Patients with altered mental status
  8. Illiterate patients or foreigners

Trial design

72 participants in 2 patient groups

No premedication
Experimental group
Description:
No premedication before sedation
Treatment:
Drug: No premedication
Midazolam
Active Comparator group
Description:
Premedication with midazolam before sedation
Treatment:
Drug: midazolam 0.02mg/kg

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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