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

Study Overview
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Brief Summary
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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
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Early Gastric Cancer, Gastric Adenoma

Intervention / Treatment
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* Drug: midazolam 0.02mg/kg
* Drug: No premedication


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: No premedication<br>No premedication before sedation | Drug: No premedication<br>* No premedication before sedation for endoscopic submucosal dissection<br>|
| Active Comparator: Midazolam<br>Premedication with midazolam before sedation | Drug: midazolam 0.02mg/kg<br> <br> * Other names: Premedication of midazolam 0.02mg/kg before sedation for endoscopic submucosal dissection;|

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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midazolam, satisfaction, endoscopic submucosal dissection