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

NCT02504164 | Completed

• 1 other identifier: 4-2014-0310
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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.

Conditions

Early Gastric Cancer; Gastric Adenoma

Keywords

midazolam; satisfaction; endoscopic submucosal dissection

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (2)

No premedication

EXPERIMENTAL

No premedication before sedation

Drug: No premedication

Midazolam

ACTIVE COMPARATOR

Premedication with midazolam before sedation

Drug: midazolam 0.02mg/kg

Interventions

midazolam 0.02mg/kg DRUG

Also known as: Premedication of midazolam 0.02mg/kg before sedation for endoscopic submucosal dissection

Midazolam

No premedication DRUG

No premedication before sedation for endoscopic submucosal dissection

No premedication

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

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

Seoul, Seoul, 120-752, South Korea

Location

MeSH Terms

Conditions

Stomach Neoplasms; Personal Satisfaction

Interventions

Midazolam; Endoscopic Mucosal Resection

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Behavior

Intervention Hierarchy (Ancestors)

Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Endoscopy, Gastrointestinal; Endoscopy, Digestive System; Diagnostic Techniques, Digestive System; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 14, 2015
• First Posted: July 21, 2015
• Study Start: September 1, 2014
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: March 7, 2016

Record last verified: 2016-03

Locations

KR (1)