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

JRCT ID: jRCTs041190031

Registered date:27/05/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Patients who are necessary for upper gastroendoscopy
• Date of first enrollment: 01/07/2019
• Target sample size: 500
• Study type: Interventional

Intervention(s)

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 swallowing and start the examination. On the other hand, the spray is not used to group A.
After these procedures are completed, the doctor enters the examination room and conduct endoscopy. Therefore, he/she does not know whether the pharyngeal anesthesia has been performed or not(single-blind examination).

Outcome(s)

• Primary Outcome: Difference in the success rate of pharynx observation between both groups

Secondary Outcome

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

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

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

Exclude 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.

Related Information

• Primary Sponsor: Kaneko Shuichi