Meperidine as the Single Sedative Agent During Esophagogastroduodenoscopy

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

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.

Study Overview

• Status: Completed
• Conditions: Esophagogastroduodenoscopy
• Intervention / Treatment: Drug: Meperidine; Drug: normal saline

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.

• Study Type: Interventional
• Enrollment (Actual): 140
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Chia-Yi, Taiwan, 622
    • Dalin Tzu Chi General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: meperidine; 25 mg of meperidine is injected intramuscularly before EGD	Drug: Meperidine; intramuscular, 25 mg, 5 to 10 minutes before EGD
Placebo Comparator: placebo; placebo was given intramuscularly before EGD	Drug: normal saline; 25 ml of normal saline, intramuscular, 5 to 10 minutes before EGD

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
patient and endoscopist satisfaction score	patient and endoscopist satisfaction with the procedure, score 0(not satisfied at all)-10 (very satisfied	9 months
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
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

Collaborators and Investigators

• Sponsor: Dalin Tzu Chi General Hospital
• Investigators: Principal Investigator: Yu-Hsi Hsieh, Dr., Dalin Tzu Chi General Hospital

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: June 1, 2011
• Primary Completion (Actual): February 1, 2012
• Study Completion (Actual): February 1, 2012

Study Registration Dates

• First Submitted: February 28, 2012
• First Submitted That Met QC Criteria: March 7, 2012
• First Posted (Estimate): March 8, 2012

Study Record Updates

• Last Update Posted (Estimate): March 8, 2012
• Last Update Submitted That Met QC Criteria: March 7, 2012
• Last Verified: March 1, 2012

More Information

Terms related to this study

• Keywords: esophagogastroduodenoscopy; unsedated; meperidine; minimal sedation
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Opioid; Narcotics; Adjuvants, Anesthesia; Meperidine
• Other Study ID Numbers: DalinTCGH-hsieh-02