Clinical trial NCT01547520: Meperidine as the Single Sedative Agent During Esophagogastroduodenoscopy
Official title: Meperidine as the Single Sedative Agent During Esophagogastroduodenoscopy, a Double-blind, Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Esophagogastroduodenoscopy
Keywords: meperidine
esophagogastroduodenoscopy
unsedated
minimal sedation
Lead sponsor: Dalin Tzu Chi General Hospital
Sponsor class: OTHER
First posted: 2012-03-08
Enrollment: 140
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: discomfort score during esophageal intubation
timeFrame: 9 months
Secondary outcomes:
measure: patient and endoscopist satisfaction score
timeFrame: 9 months
measure: patient tolerance of the procedure
timeFrame: 9 months
measure: endoscopist perception of patient tolerance ,
timeFrame: 9 months
Other outcomes:
Locations:
city: Chia-Yi
country: Taiwan
facility: Dalin Tzu Chi General Hospital
Study officials:
affiliation: Dalin Tzu Chi General Hospital
name: Yu-Hsi Hsieh, Dr.
role: PRINCIPAL_INVESTIGATOR
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: 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.
citation: 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.
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.