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Completed

NCT Number: NCT02504164

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

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.

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Key information

Conditions

Early Gastric Cancer Behavior Digestive System Diseases Digestive System Neoplasms Gastric Adenoma Gastrointestinal Diseases Gastrointestinal Neoplasms Neoplasms Neoplasms by Site Personal Satisfaction Stomach Diseases Stomach Neoplasms

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institue, Yonsei Universiy College of Medicine

Seoul, 120-752, South Korea

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

midazolam 0.02mg/kg

Drug

Other names: Premedication of midazolam 0.02mg/kg before sedation for endoscopic submucosal dissection

No premedication

Drug

No premedication before sedation for endoscopic submucosal dissection

Primary outcomes

  1. Overall patient satisfaction scores on a scale from 0 to 10

    Time frame: 24 hours after ESD

  2. Willingness to receive same method of sedation for ESD in the future as yes or no

    Time frame: 24 hours after ESD

  3. Post-procedural pain on a VAS scale of 0 to 10

    Time frame: at 1 hour and 24 hours after ESD

  4. Any recall of the ESD procedure on a scale from 0 to 2 (0; no recall, 1; partial recall, 2; can recall most of procedure)

    Time frame: 24 hours after ESD

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Registry information

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Jul 21, 2015
Registry last updated
Mar 7, 2016

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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