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

Not Applicable

Completed

• Conditions: Early Gastric Cancer; Gastric Adenoma
• Interventions: Drug: midazolam 0.02mg/kg; Drug: No premedication

• Registration Number: NCT02504164
• Lead Sponsor: Yonsei University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-09
• Study First Submitted: 2015-07-14
• Study First Submitted QC: 2015-07-19
• Study First Posted: 2015-07-21
• Primary Completion: 2015-12
• Study Completion: 2015-12
• Status Verified: 2016-03
• Last Update Submitted: 2016-03-03
• Last Update Posted: 2016-03-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 72

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Midazolam	midazolam 0.02mg/kg	Premedication with midazolam before sedation
No premedication	No premedication	No premedication before sedation

Primary Outcome Measures

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

Trial Locations

Locations (1)

Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institue, Yonsei Universiy College of Medicine; 🇰🇷 Seoul, Korea, Republic of