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

Early Gastric Cancer Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02504164
• Other study ID #: 4-2014-0310
• Status: Completed
• Phase: N/A
• First received: July 14, 2015
• Last updated: March 3, 2016
• Start date: September 2014
• Est. completion date: December 2015

Study information

• Verified date: March 2016
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor)

Related Conditions & MeSH terms

• Early Gastric Cancer
• Gastric Adenoma

Intervention

Drug:
• midazolam 0.02mg/kg

• No premedication
No premedication before sedation for endoscopic submucosal dissection

Locations

Country	Name	City	State
Korea, Republic of	Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institue, Yonsei Universiy College of Medicine	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

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