Patients Undergoing Diagnostic EGDNCT01948921

Meperidine for Patients Expected to Have Poor Tolerance During Diagnostic Esophagogastroduodenoscopy.

A study testing Meperidine in people with Patients Undergoing Diagnostic EGD, run by Dalin Tzu Chi General Hospital at 1 site in Taiwan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 20 to 80 years
Conditions the study is for: Patients Undergoing Diagnostic EGD
What is being tested?: Meperidine
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 110 participants
Where: 1 siteTaiwan
Study dates: Sep 2013to Mar 2017
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 20 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

female youger than 65 years with high anxiety level
patients with previous poor tolerance of EGD

Who cannot join

a therapeutic EGD
sedation with other agents
contraindication to Buscopan (hyoscine N-butylbromide) or meperidine
American Society of Anesthesiology (ASA) risk Class 3 or higher, renal failure
age less than 20 years or more than 80 years
pregnancy
refusal to provide written informed consent. All participants signed written informed consents

Trial locations and contacts

1 site in 1 country.

Taiwan1 site

Buddhist Dalin Tzu Chi General Hospital
Chiayi City, Taiwan, 622

Other trials in Taiwan

About this study

Official title: Meperidine as the Single Sedative Agent for Patients Expected to Have Poor Tolerance During Diagnostic Esophagogastroduodenoscopy.

Our pilot results showed that meperidine reduce patient discomfort during EGD (esophagogastroduodenoscopy). But many patients can tolerate EGD well without any sedative agents. So the investigators target the use of meperidine on patients expected to have poor tolerance in this study, which includ young females with high anxiety level and patients with prior poor tolerance. The investigators test the hypothesis that meperidine improves tolerance and alleviates discomfort for patients expected to have poor tolerance during diagnostic EGD.

Conditions: Patients Undergoing Diagnostic EGD
Being tested: placebo, Meperidine
Keywords: EGD, tolerance, discomfort

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

placeboDrug
MeperidineDrug

Study groups in NCT01948921
Study group	Role	What they receive
placebo	Placebo comparator	1 ml normal saline will be given 5 minutes before EGD Receives: Drug: placebo
meperidine	Active comparator	25 mg intramuscular meperidine will be given 5 minutes before EGD Receives: Drug: Meperidine

What is being measured

The primary outcome is the main question the study is designed to answer.

discomfort score during esophageal intubation
self-reported discomfort score during esophageal intubation, assessed with a 0 to 10 (0 = none; 10 = unbearable) visual analog scale (VAS).
Measured: 10 minutes

Secondary outcomes (4)

patient discomfort score during the procedure
Measured: 10 minutes
patients satisfaction score
Measured: 10 minutes
patient tolerance score evaluated by the endoscopist
Measured: 10 minutes
endoscopist satisfaction score
Measured: 10 minutes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 2013Mar 2017

First posted24 Sep 2013 (estimated)
Study startSep 2013
Primary completionMar 2017
Study completionMar 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (4)Papers the sponsor has linked to this study.
Other trials for Patients Undergoing Diagnostic EGDStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Diagnosis
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 110 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01948921
Sponsor's protocol ID: DalinTCGH-hsieh-2013-3
Status last verified: Mar 2017
First submitted: 19 Sep 2013
Last updated: 20 Mar 2017
Results posted: No
Data monitoring committee: Yes

Publications

Abraham NS, Fallone CA, Mayrand S, Huang J, Wieczorek P, Barkun AN. Sedation versus no sedation in the performance of diagnostic upper gastrointestinal endoscopy: a Canadian randomized controlled cost-outcome study. Am J Gastroenterol. 2004 Sep;99(9):1692-9. doi: 10.1111/j.1572-0241.2004.40157.x.
PubMed 15330904
Hsieh YH, Lin HJ, Hsieh JJ, Tseng KC, Tseng CW, Hung TH, Leung FW. Meperidine as the single sedative agent during esophagogastroduodenoscopy, a double-blind, randomized, controlled study. J Gastroenterol Hepatol. 2013 Jul;28(7):1167-73. doi: 10.1111/jgh.12183.
PubMed 23431993
Ishido S, Kinoshita Y, Kitajima N, Itoh T, Nishiyama K, Tojo M, Yano T, Inatome T, Fukuzaki H, Chiba T. Fentanyl for sedation during upper gastrointestinal endoscopy. Gastrointest Endosc. 1992 Nov-Dec;38(6):689-92. doi: 10.1016/s0016-5107(92)70565-3.
PubMed 1473671
Laluna L, Allen ML, Dimarino AJ Jr. The comparison of midazolam and topical lidocaine spray versus the combination of midazolam, meperidine, and topical lidocaine spray to sedate patients for upper endoscopy. Gastrointest Endosc. 2001 Mar;53(3):289-93. doi: 10.1016/s0016-5107(01)70400-2.
PubMed 11231385

Study at a glance

From the registry record, last updated by the sponsor on 20 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Meperidine as the Single Sedative Agent for Patients Expected to Have Poor Tolerance During Diagnostic Esophagogastroduodenoscopy.
ClinicalTrials.gov ID: NCT01948921
Acronym / sponsor ID: DalinTCGH-hsieh-2013-3
Conditions: Patients Undergoing Diagnostic EGD
Keywords: EGD, tolerance, discomfort
Study type: Interventional
Recruitment status: Completed
Enrolment: 110 participants (actual)
Lead sponsor: Dalin Tzu Chi General HospitalUniversity, hospital or other
Study start: Sep 2013
Primary completion: Mar 2017 (actual)
Study completion: Mar 2017 (actual)
First posted: 24 Sep 2013 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Diagnosis
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
placebo	Placebo comparator	Drug: placebo1 ml normal saline will be given 5 minutes before EGD
meperidine	Active comparator	Drug: Meperidine25 mg intramuscular meperidine will be given 5 minutes before EGD

Who may qualify

Ages: 20 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

female youger than 65 years with high anxiety level
patients with previous poor tolerance of EGD

Key exclusion criteria (7 listed)

a therapeutic EGD
sedation with other agents
contraindication to Buscopan (hyoscine N-butylbromide) or meperidine
American Society of Anesthesiology (ASA) risk Class 3 or higher, renal failure
age less than 20 years or more than 80 years

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
placebo	Drug	placebo
Meperidine	Drug	meperidine

Primary outcome

discomfort score during esophageal intubation
Time frame: 10 minutes
self-reported discomfort score during esophageal intubation, assessed with a 0 to 10 (0 = none; 10 = unbearable) visual analog scale (VAS).

4 secondary outcomes

patient discomfort score during the procedure
Time frame: 10 minutes
patients satisfaction score
Time frame: 10 minutes
patient tolerance score evaluated by the endoscopist
Time frame: 10 minutes
endoscopist satisfaction score
Time frame: 10 minutes

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2017.
Background: PubMed 15330904Abraham NS, Fallone CA, Mayrand S, Huang J, Wieczorek P, Barkun AN. Sedation versus no sedation in the performance of diagnostic upper gastrointestinal endoscopy: a Canadian randomized controlled cost-outcome study. Am J Gastroenterol. 2004 Sep;99(9):1692-9. doi: 10.1111/j.1572-0241.2004.40157.x.
Background: PubMed 23431993Hsieh YH, Lin HJ, Hsieh JJ, Tseng KC, Tseng CW, Hung TH, Leung FW. Meperidine as the single sedative agent during esophagogastroduodenoscopy, a double-blind, randomized, controlled study. J Gastroenterol Hepatol. 2013 Jul;28(7):1167-73. doi: 10.1111/jgh.12183.
Background: PubMed 1473671Ishido S, Kinoshita Y, Kitajima N, Itoh T, Nishiyama K, Tojo M, Yano T, Inatome T, Fukuzaki H, Chiba T. Fentanyl for sedation during upper gastrointestinal endoscopy. Gastrointest Endosc. 1992 Nov-Dec;38(6):689-92. doi: 10.1016/s0016-5107(92)70565-3.
Background: PubMed 11231385Laluna L, Allen ML, Dimarino AJ Jr. The comparison of midazolam and topical lidocaine spray versus the combination of midazolam, meperidine, and topical lidocaine spray to sedate patients for upper endoscopy. Gastrointest Endosc. 2001 Mar;53(3):289-93. doi: 10.1016/s0016-5107(01)70400-2.

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Meperidine in people with Patients Undergoing Diagnostic EGD, run by Dalin Tzu Chi General Hospital at 1 site in Taiwan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

discomfort score during esophageal intubation (time frame: 10 minutes). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01948921, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2017.