Trial Outcomes & Findings for Trial of New Pretreatment Method in Transnasal Endoscopy (NCT NCT01708967)

Results Overview

We difine the success of transnasal endoscopy as follows: the pateint underwent transnasal endoscopy without signicant complaint nor side effects. We difine the failure of transnasal endoscopy as follows: the patient cannot tolerate insertion of the endoscope; the patient presents side effects such as epistaxis, pain, or a decrease in O2 saturation; and the endoscope cannot pass through the nasal or oral cavity.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

100 participants

Primary outcome timeframe

During transnasal endoscopy, up to 1 hours

Results posted on

2014-03-13

Participant Flow

Participant milestones

Participant milestones
Measure	Catheter-free Method We explored success rate, side effects, and vital signs in patients with one-time spray method. Intervention: one-time spray of epinephrine (1cc) plus 4% lidocaine (4cc) pretreatment method for transnasal endoscopy : one-time spray method : patients are given simethicone (5cc) and lidocaine (2%, 10cc). After that, epinephrine (1cc) and lidocaine (2%, 3cc) are injected in both nose and mouth. Lastly, buscopan Intra Muscular (IM) is injected. spray+catheter method: patients are given simethicone (10cc). Next, epinephrine and lidocaine (4%, 4cc) are injected in both nose and mouth. Following this step, benoxinate hydrochloride (5cc) is inhaled by the patients. Subsequently, the patients are catheterized for 10 minutes using the 7Fr. Nelaton catheter. Finally, buscopan IM is injected.	Catheter-insertion Method We explored success rate, side effects, and vital signs in patients with spray+catheter method. Intervention: use both spray and catheter pretreatment method for transnasal endoscopy : one-time spray method : patients are given simethicone (5cc) and lidocaine (2%, 10cc). After that, epinephrine (1cc) and lidocaine (2%, 3cc) are injected in both nose and mouth. Lastly, buscopan Intra Muscular (IM) is injected. spray+catheter method: patients are given simethicone (10cc). Next, epinephrine and lidocaine (4%, 4cc) are injected in both nose and mouth. Following this step, benoxinate hydrochloride (5cc) is inhaled by the patients. Subsequently, the patients are catheterized for 10 minutes using the 7Fr. Nelaton catheter. Finally, buscopan IM is injected.
Overall Study STARTED	50	50
Overall Study COMPLETED	50	43
Overall Study NOT COMPLETED	0	7

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Trial of New Pretreatment Method in Transnasal Endoscopy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Catheter-free Method n=50 Participants We explored success rate, side effects, and vital signs in patients with one-time spray method. Intervention: one-time spray of epinephrine (1cc) plus 4% lidocaine (4cc)	Catheter-insertion Method n=50 Participants We explored success rate, side effects, and vital signs in patients with spray+catheter method. Intervention: use both spray and catheter	Total n=100 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	39 Participants n=5 Participants	37 Participants n=7 Participants	76 Participants n=5 Participants
Age, Categorical >=65 years	11 Participants n=5 Participants	13 Participants n=7 Participants	24 Participants n=5 Participants
Age, Continuous	58.4 years STANDARD_DEVIATION 10.8 • n=5 Participants	59.7 years STANDARD_DEVIATION 12.3 • n=7 Participants	59.00 years STANDARD_DEVIATION 11.5 • n=5 Participants
Sex: Female, Male Female	25 Participants n=5 Participants	27 Participants n=7 Participants	52 Participants n=5 Participants
Sex: Female, Male Male	25 Participants n=5 Participants	23 Participants n=7 Participants	48 Participants n=5 Participants
Region of Enrollment Korea, Republic of	50 participants n=5 Participants	50 participants n=7 Participants	100 participants n=5 Participants

PRIMARY outcome

Timeframe: During transnasal endoscopy, up to 1 hours

We difine the success of transnasal endoscopy as follows: the pateint underwent transnasal endoscopy without signicant complaint nor side effects. We difine the failure of transnasal endoscopy as follows: the patient cannot tolerate insertion of the endoscope; the patient presents side effects such as epistaxis, pain, or a decrease in O2 saturation; and the endoscope cannot pass through the nasal or oral cavity.

Outcome measures

Outcome measures
Measure	Catheter-free Method n=50 Participants We explored success rate, side effects, and vital signs in patients with one-time spray method. Intervention: one-time spray of epinephrine (1cc) plus 4% lidocaine (4cc) pretreatment method for transnasal endoscopy : one-time spray method : patients are given simethicone (5cc) and lidocaine (2%, 10cc). After that, epinephrine (1cc) and lidocaine (2%, 3cc) are injected in both nose and mouth. Lastly, buscopan Intra Muscular (IM) is injected. spray+catheter method: patients are given simethicone (10cc). Next, epinephrine and lidocaine (4%, 4cc) are injected in both nose and mouth. Following this step, benoxinate hydrochloride (5cc) is inhaled by the patients. Subsequently, the patients are catheterized for 10 minutes using the 7Fr. Nelaton catheter. Finally, buscopan IM is injected.	Catheter-insertion Method n=43 Participants We explored success rate, side effects, and vital signs in patients with spray+catheter method. Intervention: use both spray and catheter pretreatment method for transnasal endoscopy : one-time spray method : patients are given simethicone (5cc) and lidocaine (2%, 10cc). After that, epinephrine (1cc) and lidocaine (2%, 3cc) are injected in both nose and mouth. Lastly, buscopan Intra Muscular (IM) is injected. spray+catheter method: patients are given simethicone (10cc). Next, epinephrine and lidocaine (4%, 4cc) are injected in both nose and mouth. Following this step, benoxinate hydrochloride (5cc) is inhaled by the patients. Subsequently, the patients are catheterized for 10 minutes using the 7Fr. Nelaton catheter. Finally, buscopan IM is injected.
Success Rate of Transnasal Endoscopy	88 percentage of Participants Interval 80.0 to 96.0	88 percentage of Participants Interval 80.0 to 96.0

SECONDARY outcome

Timeframe: before, during, and after transnasal endoscopy

Blood pressure, heart rate, and O2 saturation were assessed.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: after transnasal endoscopy

Patients were asked to score how well they felt during endoscopy using a visual analog scale; they were also asked whether they would accept one-time spray method or spray+catheter method in the future if necessary.

Outcome measures

Outcome data not reported

Adverse Events

Catheter-free Method

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Catheter-insertion Method

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Ki Tae Suk

Department of Internal Medicine, Hallym University College of Medicine, Chuncheon, Korea

Phone: +82-33-240-5826

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: OTHER