Meperidine as the Single Sedative Agent During Esophagogastroduodenoscopy

NCT ID: NCT01547520

Last Updated: 2012-03-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-06-30

Study Completion Date

2012-02-29

Brief Summary

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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.

Detailed Description

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Unsedated esophagogastroduodenoscopy (EGD) is a useful tool for upper gastrointestinal tract examination and therapy, but it is uncomfortable for many patients. Meperidine has been widely used in colonoscopic examination for many years; however, its use in EGD has not been completely evaluated.

Conditions

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Esophagogastroduodenoscopy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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meperidine

25 mg of meperidine is injected intramuscularly before EGD

Group Type EXPERIMENTAL

Meperidine

Intervention Type DRUG

intramuscular, 25 mg, 5 to 10 minutes before EGD

placebo

placebo was given intramuscularly before EGD

Group Type PLACEBO_COMPARATOR

normal saline

Intervention Type DRUG

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

Interventions

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Meperidine

intramuscular, 25 mg, 5 to 10 minutes before EGD

Intervention Type DRUG

normal saline

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

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* 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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

65 Years

Eligible Sex

Accepts Healthy Volunteers

No

Sponsors

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Dalin Tzu Chi General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Yu-Hsi Hsieh, Dr.

Role: PRINCIPAL_INVESTIGATOR

Dalin Tzu Chi General Hospital

Locations

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Dalin Tzu Chi General Hospital

Chiayi City, Taiwan, Taiwan

Site Status

Countries

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Taiwan

References

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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.

Reference Type BACKGROUND
PMID: 15330904 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 1473671 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11231385 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 8651156 (View on PubMed)

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.

Reference Type DERIVED
PMID: 23431993 (View on PubMed)

Other Identifiers

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DalinTCGH-hsieh-02

Identifier Type: -

Identifier Source: org_study_id

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