NCT01547520

Brief Summary

Upper endoscopy is uncomfortable for most patients. Meperidine has both sedative and analgesic effects, so its use may be helpful for patients receiving upper endoscopy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
140

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2011

Shorter than P25 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

June 1, 2011

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2012

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

February 28, 2012

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 8, 2012

Completed
Last Updated

March 8, 2012

Status Verified

March 1, 2012

Enrollment Period

8 months

First QC Date

February 28, 2012

Last Update Submit

March 7, 2012

Conditions

Esophagogastroduodenoscopy

Keywords

meperidineesophagogastroduodenoscopyunsedatedminimal sedation

Outcome Measures

Primary Outcomes (1)

  • discomfort score during esophageal intubation

    patient self-reported discomfort score during esophageal intubation, assessed with a 0 to 10 visual analog scale (VAS)

    9 months

Secondary Outcomes (3)

  • patient and endoscopist satisfaction score

    9 months

  • patient tolerance of the procedure

    9 months

  • endoscopist perception of patient tolerance ,

    9 months

Study Arms (2)

meperidine

EXPERIMENTAL

25 mg of meperidine is injected intramuscularly before EGD

Drug: Meperidine

placebo

PLACEBO COMPARATOR

placebo was given intramuscularly before EGD

Drug: normal saline

Interventions

MeperidineDRUG

intramuscular, 25 mg, 5 to 10 minutes before EGD

meperidine
normal salineDRUG

25 ml of normal saline, intramuscular, 5 to 10 minutes before EGD

placebo

Eligibility Criteria

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

You may qualify if:

  • Patients undergoing diagnostic upper endoscopy in our endoscopic room were enrolled.

You may not qualify if:

  • A therapeutic upper endoscopic procedure, sedated endoscopy, contraindication to Buscopan (hyoscine N-butylbromide)
  • Allergy to meperidine
  • American Society of Anesthesiology (ASA) risk Class 3 or higher
  • Renal failure
  • Decompensated cirrhosis
  • Aged less than 20 years or more than 65 years
  • Pregnancy
  • Refusal to provide written informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dalin Tzu Chi General Hospital

Chiayi City, Taiwan, 622, Taiwan

Location

Related Publications (5)

  • 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

  • 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

  • Diab FH, King PD, Barthel JS, Marshall JB. Efficacy and safety of combined meperidine and midazolam for EGD sedation compared with midazolam alone. Am J Gastroenterol. 1996 Jun;91(6):1120-5.

    PMID: 8651156BACKGROUND

  • 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: 23431993DERIVED

MeSH Terms

Interventions

MeperidineSaline Solution

Intervention Hierarchy (Ancestors)

Isonipecotic AcidsAcids, HeterocyclicHeterocyclic CompoundsPiperidinesHeterocyclic Compounds, 1-RingCrystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Officials

  • Yu-Hsi Hsieh, Dr.

    Dalin Tzu Chi General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 28, 2012

First Posted

March 8, 2012

Study Start

June 1, 2011

Primary Completion

February 1, 2012

Study Completion

February 1, 2012

Last Updated

March 8, 2012

Record last verified: 2012-03

Locations

TW(1)