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

NCT02504164 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2016-03-07

No results posted yet for this study

Summary

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.

Conditions

  • Early Gastric Cancer
  • Gastric Adenoma

Interventions

DRUG

midazolam 0.02mg/kg

DRUG

No premedication

No premedication before sedation for endoscopic submucosal dissection

Sponsors & Collaborators

  • Yonsei University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-09-30
Primary Completion
2015-12-31
Completion
2015-12-31

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02504164 on ClinicalTrials.gov