Meperidine as the Single Sedative Agent During Esophagogastroduodenoscopy

Esophagogastroduodenoscopy Clinical Trial

Official title:

Meperidine as the Single Sedative Agent During Esophagogastroduodenoscopy, a Double-blind, Randomized Controlled Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01547520
• Other study ID #: DalinTCGH-hsieh-02
• Status: Completed
• Phase: N/A
• First received: February 28, 2012
• Last updated: March 7, 2012
• Start date: June 2011
• Est. completion date: February 2012

Study information

• Verified date: March 2012
• Source: Dalin Tzu Chi General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: February 2012
• Est. primary completion date: February 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Esophagogastroduodenoscopy

Intervention

Drug:
• Meperidine
intramuscular, 25 mg, 5 to 10 minutes before EGD
• normal saline
25 ml of normal saline, intramuscular, 5 to 10 minutes before EGD

Locations

Country	Name	City	State
Taiwan	Dalin Tzu Chi General Hospital	Chia-Yi

Sponsors (1)

Lead Sponsor	Collaborator
Dalin Tzu Chi General Hospital

Country where clinical trial is conducted

Taiwan, 

References & 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	patient and endoscopist satisfaction score	patient and endoscopist satisfaction with the procedure, score 0(not satisfied at all)-10 (very satisfied	9 months
Secondary	patient tolerance of the procedure	patolerace of the EGD, evaluate by the endoscopist, score 0 (best tolerance)-10 (very poor tolerance, the procedure could not be completed)	9 months
Secondary	endoscopist perception of patient tolerance ,	endoscopist evaluation of patient tolerance during EGD, score 0 (best tolerance)- 10 (worst tolerance, the procedure can not be completed)	9 months