Clinical trial NCT01948921: Meperidine for Patients Expected to Have Poor Tolerance During Diagnostic Esophagogastroduodenoscopy.
Official title: Meperidine as the Single Sedative Agent for Patients Expected to Have Poor Tolerance During Diagnostic Esophagogastroduodenoscopy.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Patients Undergoing Diagnostic EGD
Keywords: EGD
tolerance
discomfort
Lead sponsor: Dalin Tzu Chi General Hospital
Sponsor class: OTHER
First posted: 2013-09-24
Enrollment: 110
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* 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

Primary outcomes:
measure: discomfort score during esophageal intubation
timeFrame: 10 minutes
Secondary outcomes:
measure: patient discomfort score during the procedure
timeFrame: 10 minutes
measure: patients satisfaction score
timeFrame: 10 minutes
measure: patient tolerance score evaluated by the endoscopist
timeFrame: 10 minutes
measure: endoscopist satisfaction score
timeFrame: 10 minutes
Other outcomes:
Locations:
city: Chia-Yi
country: Taiwan
facility: Buddhist Dalin Tzu Chi General Hospital
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.