NCT01948921

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
110

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2013

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

September 19, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 24, 2013

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2017

Completed
Last Updated

March 20, 2017

Status Verified

March 1, 2017

Enrollment Period

3.5 years

First QC Date

September 19, 2013

Last Update Submit

March 16, 2017

Conditions

Patients Undergoing Diagnostic EGD

Keywords

EGDtolerancediscomfort

Outcome Measures

Primary Outcomes (1)

  • 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).

    10 minutes

Secondary Outcomes (4)

  • patient discomfort score during the procedure

    10 minutes

  • patients satisfaction score

    10 minutes

  • patient tolerance score evaluated by the endoscopist

    10 minutes

  • endoscopist satisfaction score

    10 minutes

Study Arms (2)

placebo

PLACEBO COMPARATOR

1 ml normal saline will be given 5 minutes before EGD

Drug: placebo

meperidine

ACTIVE COMPARATOR

25 mg intramuscular meperidine will be given 5 minutes before EGD

Drug: Meperidine

Interventions

placeboDRUG
placebo
MeperidineDRUG
meperidine

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Buddhist Dalin Tzu Chi General Hospital

Chiayi City, Taiwan, 622, Taiwan

Location

Related Publications (4)

  • 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.

    PMID: 15330904BACKGROUND

  • 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.

    PMID: 23431993BACKGROUND

  • 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.

    PMID: 1473671BACKGROUND

  • 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.

    PMID: 11231385BACKGROUND

MeSH Terms

Interventions

Meperidine

Intervention Hierarchy (Ancestors)

Isonipecotic AcidsAcids, HeterocyclicHeterocyclic CompoundsPiperidinesHeterocyclic Compounds, 1-Ring

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief of Gastroenterology Endoscopy Suite

Study Record Dates

First Submitted

September 19, 2013

First Posted

September 24, 2013

Study Start

September 1, 2013

Primary Completion

March 1, 2017

Study Completion

March 1, 2017

Last Updated

March 20, 2017

Record last verified: 2017-03

Locations

TW(1)