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Benzodiazepine

Midazolam Sedation for Endoscopy

Phase < 1
Recruiting
Research Sponsored by Greg S Cohen MD LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Must not have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Upthrough study completion, an average of 1 year
Awards & highlights
No Placebo-Only Group

Study Summary

This trial is designed to see if midazolam alone is as effective and safe as a combination of midazolam and fentanyl for GI endoscopy.

Eligible Conditions
  • Anesthesia
  • Endoscopy
  • Colonoscopy
  • Conscious Sedation

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of 1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Difference in pain pre and post procedure
Pain felt during the procedure
adequacy of sedation
Secondary outcome measures
Adenoma detection rate
Colonoscopy withdrawal time
Hemodynamic or respiratory issues during procedure
+9 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: midazolam aloneExperimental Treatment1 Intervention
Patients in this arm will receive conscious sedation with medazepam alone
Group II: midazolam and fentanylActive Control1 Intervention
Patients in this arm will receive standard conscious sedation with midazolam and fentanyl

Find a Location

Who is running the clinical trial?

Greg S Cohen MD LLCLead Sponsor

Media Library

Midazolam (Benzodiazepine) Clinical Trial Eligibility Overview. Trial Name: NCT04807101 — Phase < 1
Anesthesia Research Study Groups: midazolam and fentanyl, midazolam alone
Anesthesia Clinical Trial 2023: Midazolam Highlights & Side Effects. Trial Name: NCT04807101 — Phase < 1
Midazolam (Benzodiazepine) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04807101 — Phase < 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there still opportunities for individuals to participate in this research?

"Affirmative. Clinicaltrials.gov provides evidence that this research project, which launched on April 5th 2021, is actively recruiting subjects. Approximately 772 participants are sought from a single medical facility."

Answered by AI

Is midazolam being studied independently in any other investigations?

"Presently, there are 65 ongoing experiments studying the effects of midazolam alone. 10 of those trials have reached Phase 3 and the majority of them are located in Porto Alegre, California while 724 other medical centres run clinical studies involving this medication."

Answered by AI

Is this trial accepting participants aged 25 or older?

"According to the stated rules of this trial, only individuals between 18 and 75 years old qualify. There are 58 studies open for minors while 156 trials focus on seniors."

Answered by AI

In what treatments is midazolam administered as a sole agent?

"Midazolam is commonly administered to provide tranquillity, and has been used to induce forgetfulness, combat convulsive seizures, and treat the symptoms of anxiety."

Answered by AI

How extensive is the participant pool for this research endeavor?

"Affirmative. Per the information on clinicaltrials.gov, this research is still recruiting participants who meet the eligibility criteria. It was first posted on April 5th 2021 and last updated July 26th 2021. The study requires 772 enrollees from a single location to be completed successfully."

Answered by AI

Who would be the ideal subjects for this research endeavor?

"In order to participate in this medical trial, candidates must have previously undergone endoscopy and be age 18-75. Currently, 772 individuals are being recruited."

Answered by AI

What are the major goals of this clinical trial?

"This trial will measure sedation effectiveness over a 24 hour period and also take into account secondary performance metrics such as desaturation, hypotension and withdrawal time. These latter measurements are derived from nurse reported observations combined with retrospective chart reviews."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Sedation Regimens in GI Endoscopy
Greg Cohen 2021. "Sedation Regimens in GI Endoscopy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04807101.
~215 spots leftby Dec 2024
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