midazolam alone for Anaesthesia therapy

Phase-Based Estimates
1
Effectiveness
1
Safety
Northwestern Memorial Hospital, Chicago, IL
+3 More
midazolam alone - Drug
Eligibility
18+
All Sexes
Eligible conditions
Anaesthesia therapy

Study Summary

This study is evaluating whether midazolam alone is as effective as midazolam and fentanyl for conscious sedation for endoscopy.

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Eligible Conditions

  • Anaesthesia therapy
  • Colonoscopy
  • Sedation, Conscious
  • Endoscopy

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Compared to trials

Study Objectives

This trial is evaluating whether midazolam alone will improve 3 primary outcomes and 12 secondary outcomes in patients with Anaesthesia therapy. Measurement will happen over the course of 1 day.

1 day
Difference in pain pre and post procedure
Hemodynamic or respiratory issues during procedure
Hypotension during procedure
Nurse Reported Nausea
Nurse reported pain
O2 desaturation during procedure
Pain felt during the procedure
Patient reported Nausea
Physician reported patient cooperation during the procedure
Physician reported patient discomfort during the procedure
adequacy of sedation
Year 1
Adenoma detection rate
Colonoscopy withdrawal time
cecal intubation rate
cecal intubation time

Trial Safety

Safety Estimate

1 of 3

Compared to trials

Trial Design

2 Treatment Groups

Control
midazolam alone

This trial requires 772 total participants across 2 different treatment groups

This trial involves 2 different treatments. Midazolam Alone is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase < 1 and are in the first stage of evaluation with people.

midazolam alone
Drug
Patients in this arm will receive conscious sedation with medazepam alone
ControlNo treatment in the control group

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: through study completion, an average of 1 year
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly through study completion, an average of 1 year for reporting.

Who is running the study

Principal Investigator
G. C.
Prof. Greg Cohen, Clinical Associate Professor of Medicine
Greg S Cohen MD LLC

Closest Location

Northwestern Memorial Hospital - Chicago, IL

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 4 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
were categorized as having either high- or low-GI fellow or trainee involvement Patients who presented for endoscopic procedures without any GI fellow or trainee involvement in the procedure were categorized as having either high- or low-GI fellow or trainee involvement. show original
English-speaking patients
Patients ≥18 years old and ≤75 years old
Outpatients presenting for EGD and/or colonoscopy planned with conscious sedation using midazolam and fentanyl

Patient Q&A Section

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

What are the signs of colonoscopy?

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Signs of colonoscopy are not specific; however, they are nonspecific. There are many possible signs of colonoscopy, but they are nonspecific and can be associated with other disorders. Signs of colonoscopy may take the form of a colonic mass or ulcerated bleeding from the bowel or stool.

Unverified Answer

Can colonoscopy be cured?

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The benefits of colonoscopy must be weighed against the disadvantages of colonoscopy in patients who are contemplating it. Only a small proportion of our patients were willing to pursue this procedure. Those who did choose to have colonoscopy did so for the perceived benefits of the procedure, so not wishing to be 'left' with the diagnosis. Those whose symptoms worsened were more likely to have an unknown cause for their symptoms.

Unverified Answer

What are common treatments for colonoscopy?

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Colonoscopy is an effective, safe, and widely used endoscopic procedure with several possible indications for physicians and patients. Many physicians prefer to use polyps or large folds in the colon as endoscopy goals. The most common treatment is use of a colonoscopy cleanser, in which case a physician usually uses a sodium phosphate solution that works by diluting the sodium phosphate so it doesn't clean away too much or too little of the mucus that coats the colon. For the cleansing of the colon after the procedure, almost always a physician uses a sodium phosphate solution that allows enough water to flow out and flush out the colon before the physician can remove polyps and other growths that can be harmful or cause inflammation in the colon.

Unverified Answer

How many people get colonoscopy a year in the United States?

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Approximately 23 million Americans have a colonoscopy annually. This is about 60% of patients screened annually based on guidelines, although there is considerable variability among endoscopists and practices. More work is needed to increase colorectal cancer screening as recommended by guidelines.

Unverified Answer

What is colonoscopy?

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Colonoscopy is an important diagnostic tool in determining a patient's susceptibility to [colon cancer](https://www.withpower.com/clinical-trials/colon-cancer). It allows for the detection and removal of precancerous or cancerous polyps of the colon and rectum. Colonoscopy is an important diagnostic tool for determining a patient's susceptibility to colon cancer. Screening for colon cancer with colonoscopy is useful to reduce the occurrence of colorectal cancer in certain populations.

Unverified Answer

What causes colonoscopy?

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There is a large body of evidence demonstrating the advantages of routine colonoscopy in patients who are not presenting with complaints of colorectal disease and for patients who have not been screened in the past. Although current practice varies, overall screening is now considered cost-effective in all groups.

Unverified Answer

Who should consider clinical trials for colonoscopy?

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There is no clear indication for conducting a clinical trial among low-risk patients for an invasive procedure like colonoscopy in low-risk patients of 40 years of age or older.

Unverified Answer

Is midazolam alone safe for people?

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The use of midazolam alone has few adverse effects. However, in contrast to other benzodiazepine analogues, the overall incidence of adverse effects is low. Therefore, when combined with other drugs, the adverse effects of midazolam are also low. People of all ages, except for children, can safely use midazolam at therapeutic doses.

Unverified Answer

What is midazolam alone?

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Midazolam alone and [pethidine and midazolam together] are equally effective at sedation induction for patients undergoing colonoscopic examinations. Midazolam alone is well tolerated and a low-cost alternative for short sedation requirements.

Unverified Answer

Does colonoscopy run in families?

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Findings from a recent study suggests that not only patients with familial adenomatous polyposis, but also those with familial ulcerative colitis seem to show a higher number of colonic adenomatous polyps and colorectal adenomas than the general population. Familiar cases have an even higher and significant number of these parameters. More research is needed in order to see whether this suggests a link between parental or familial polyposis and colorectal neoplasms, or are the genes somehow linked to these polyps that also affects these patients.

Unverified Answer

Is midazolam alone typically used in combination with any other treatments?

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Midazolam is the only thecate (midazolam-based) used in combination with radiotherapy and radiation therapy other than the standard regimen of radiotherapy for patients with stage I non-small cell lung cancer. In addition to its low incidence of toxicity and lack of significant toxicity, midazolam appears safe and effective when administered in conjunction with chemotherapy.

Unverified Answer

Have there been any new discoveries for treating colonoscopy?

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Most of the research performed to date on the treatment of colonoscopic lesions is derived from RCTs which provide high quality, high-quality evidence; however, there is an issue with the reporting of RCTs with colonoscopic lesions and it is difficult to interpret individual studies as the current best evidence for treatment of these lesions. There is an international commitment to [Report and publish studies on colonoscopy and bowel cancer in Europe and is a project of the ESCRS/EABS/WAVE/EAUC/AGROBAV/AGROFEN.

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