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Clinical Randomized Trial of the Necessity for Pharyngeal Anesthesia for Transoral Endoscopy with Intravenous Sedation by Midazolam

Clinical Randomized Trial of the Necessity for Pharyngeal Anesthesia for Transoral Endoscopy with Intravenous Sedation by Midazolam - Necessity for Pharyngeal Anesthesia for Endoscopy with Midazolam

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTs041190031
Enrollment
500
Registered
2019-05-27
Start date
2019-07-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients who are necessary for upper gastroendoscopy

Interventions

Distribute randomly to A group and B group. The staff was told the allocation result whether perform the pretreatment or not. The B group is spraied about 5 times (40 mg) to the pharynx, prompt swallo

Sponsors

Kaneko Shuichi
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) over 20 years old. 2) Informed consent to participate in this research, document consent was obtained by the volunteer's free will.

Exclusion criteria

Exclusion criteria: 1) After pharynx or laryngectomy. 2) History of pharyngeal cancer, laryngeal cancer, esophageal cancer, or undergoing treatment. 3) It is known beforehand that there are lesions requiring biopsy or magnifying observation in the pharynx. 4) Allegies of lidocaine or amide type local anesthetics. 5) Being difficult to participate in the examination because of psychosis or psychiatric symptoms 6) Midazolam contraindicated patients. 7) Seemed inappropriate as research subject.

Design outcomes

Primary

MeasureTime frame
Difference in the success rate of pharynx observation between both groups

Secondary

MeasureTime frame
1) Difference in pharyngeal observable site between the two groups (still image, animation) 2) Difference in pharyngeal observation time between both groups 3) Difference in pain in endoscopic examination between both groups 4) Observable part between the two groups in subgroup in sedation situation, medication situation etc., difference in pain level 5) Adverse events in both groups Blood pressure decrease, bradycardia, decrease of SpO2, etc. 6) Cost of both groups

Contacts

Public ContactTomoyuki Hayashi

Kanazawa University Hospital

doctorugbyknzwtym@yahoo.co.jp+81-76-265-2235

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026