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

March 3, 2016 updated by: Yonsei University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

72

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 120-752
        • Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institue, Yonsei Universiy College of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: No premedication
No premedication before sedation
Drug: No premedication
No premedication before sedation for endoscopic submucosal dissection
Active Comparator: Midazolam
Premedication with midazolam before sedation
Drug: midazolam 0.02mg/kg
Other Names:
  • Premedication of midazolam 0.02mg/kg before sedation for endoscopic submucosal dissection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Overall patient satisfaction scores on a scale from 0 to 10
Time Frame: 24 hours after ESD
24 hours after ESD
Willingness to receive same method of sedation for ESD in the future as yes or no
Time Frame: 24 hours after ESD
24 hours after ESD
Post-procedural pain on a VAS scale of 0 to 10
Time Frame: at 1 hour and 24 hours after ESD
at 1 hour and 24 hours after ESD
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
24 hours after ESD

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yonsei University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2014

Primary Completion (Actual)

December 1, 2015

Study Completion (Actual)

December 1, 2015

Study Registration Dates

First Submitted

July 14, 2015

First Submitted That Met QC Criteria

July 19, 2015

First Posted (Estimate)

July 21, 2015

Study Record Updates

Last Update Posted (Estimate)

March 7, 2016

Last Update Submitted That Met QC Criteria

March 3, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4-2014-0310

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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