Meperidine as the Single Sedative Agent During Esophagogastroduodenoscopy

• ClinicalTrials.gov Identifier: NCT01547520
• Recruitment Status: Completed
• First Posted: March 8, 2012
• Last Update Posted: March 8, 2012
• Sponsor: Dalin Tzu Chi General Hospital
• Information provided by (Responsible Party): Dalin Tzu Chi General Hospital

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Esophagogastroduodenoscopy	Drug: Meperidine; Drug: normal saline	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 140 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Diagnostic
• Official Title: Meperidine as the Single Sedative Agent During Esophagogastroduodenoscopy, a Double-blind, Randomized Controlled Study
• Study Start Date: June 2011
• Actual Primary Completion Date: February 2012
• Actual Study Completion Date: February 2012

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. discomfort score during esophageal intubation [ Time Frame: 9 months ]
   patient self-reported discomfort score during esophageal intubation, assessed with a 0 to 10 visual analog scale (VAS)

Secondary Outcome Measures :

1. patient and endoscopist satisfaction score [ Time Frame: 9 months ]
   patient and endoscopist satisfaction with the procedure, score 0(not satisfied at all)-10 (very satisfied
2. patient tolerance of the procedure [ Time Frame: 9 months ]
   patolerace of the EGD, evaluate by the endoscopist, score 0 (best tolerance)-10 (very poor tolerance, the procedure could not be completed)
3. endoscopist perception of patient tolerance , [ Time Frame: 9 months ]
   endoscopist evaluation of patient tolerance during EGD, score 0 (best tolerance)- 10 (worst tolerance, the procedure can not be completed)

Eligibility Criteria

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

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.

Contacts and Locations

Locations

Taiwan

Dalin Tzu Chi General Hospital

Chia-Yi, Taiwan, 622

Sponsors and Collaborators

Dalin Tzu Chi General Hospital

Investigators

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

More Information

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.

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.

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.

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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Dalin Tzu Chi General Hospital
• ClinicalTrials.gov Identifier: NCT01547520
• Other Study ID Numbers: DalinTCGH-hsieh-02
• First Posted: March 8, 2012
• Last Update Posted: March 8, 2012
• Last Verified: March 2012

Keywords provided by Dalin Tzu Chi General Hospital:

meperidine; esophagogastroduodenoscopy; unsedated; minimal sedation

Additional relevant MeSH terms:

Meperidine; Analgesics, Opioid; Narcotics; Central Nervous System Depressants; Physiological Effects of Drugs; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Adjuvants, Anesthesia