EsophagogastroduodenoscopyNCT01547520
Meperidine as the Single Sedative Agent During Esophagogastroduodenoscopy
A study testing Meperidine and normal saline in people with Esophagogastroduodenoscopy, run by Dalin Tzu Chi General Hospital at 1 site in Taiwan.
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. Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Esophagogastroduodenoscopy
- What is being tested?
- Meperidine and normal saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 140 participants
- Where
- 1 siteTaiwan
- Study dates
- Jun 2011to Feb 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 65 years
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing diagnostic upper endoscopy in our endoscopic room were enrolled.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Esophagogastroduodenoscopy
- Being tested
- Meperidine, normal saline
- Keywords
- meperidine, esophagogastroduodenoscopy, unsedated, minimal sedation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MeperidineDrug
intramuscular, 25 mg, 5 to 10 minutes before EGD
normal salineDrug
25 ml of normal saline, intramuscular, 5 to 10 minutes before EGD
| Study group | Role | What they receive |
|---|---|---|
| meperidine | Experimental | 25 mg of meperidine is injected intramuscularly before EGD Receives: Drug: Meperidine |
| placebo | Placebo comparator | placebo was given intramuscularly before EGD Receives: Drug: normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
discomfort score during esophageal intubation
patient self-reported discomfort score during esophageal intubation, assessed with a 0 to 10 visual analog scale (VAS)
Measured: 9 months
Secondary outcomes (3)
patient and endoscopist satisfaction score
patient and endoscopist satisfaction with the procedure, score 0(not satisfied at all)-10 (very satisfied
Measured: 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)
Measured: 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)
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2012 (estimated)
- Study startJun 2011
- Primary completionFeb 2012
- Study completionFeb 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for EsophagogastroduodenoscopyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dalin Tzu Chi General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yu-Hsi Hsieh, Dr., Principal investigator, Dalin Tzu Chi General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01547520
- Sponsor's protocol ID
- DalinTCGH-hsieh-02
- Status last verified
- Mar 2012
- First submitted
- 28 Feb 2012
- Last updated
- 8 Mar 2012
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 15330904Ishido 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.
PubMed 1473671Laluna 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.
PubMed 11231385Diab 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.
PubMed 8651156Hsieh 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.
PubMed 23431993
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Meperidine as the Single Sedative Agent During Esophagogastroduodenoscopy, a Double-blind, Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT01547520
- Acronym / sponsor ID
- DalinTCGH-hsieh-02
- Conditions
- Esophagogastroduodenoscopy
- Keywords
- meperidine, esophagogastroduodenoscopy, unsedated, minimal sedation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Dalin Tzu Chi General HospitalUniversity, hospital or other
- Study start
- Jun 2011
- Primary completion
- Feb 2012 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 8 Mar 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| meperidine | Experimental | Drug: Meperidine25 mg of meperidine is injected intramuscularly before EGD |
| placebo | Placebo comparator | Drug: normal salineplacebo was given intramuscularly before EGD |
Who may qualify
- Ages
- 20 to 65 years
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients undergoing diagnostic upper endoscopy in our endoscopic room were enrolled.
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Meperidineintramuscular, 25 mg, 5 to 10 minutes before EGD | Drug | meperidine |
| normal saline25 ml of normal saline, intramuscular, 5 to 10 minutes before EGD | Drug | placebo |
Primary outcome
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)
3 secondary outcomes
patient and endoscopist satisfaction score
Time frame: 9 months
patient tolerance of the procedure
Time frame: 9 months
endoscopist perception of patient tolerance ,
Time frame: 9 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2012.
- Background: PubMed 15330904Abraham 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.
- Background: PubMed 1473671Ishido 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.
- Background: PubMed 11231385Laluna 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.
- Background: PubMed 8651156Diab 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.
- Derived from this study: PubMed 23431993Hsieh 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.
Related trials for Esophagogastroduodenoscopy
Not yet recruitingObservational study
Media Use, Anxiety, Sedation, and Recovery in Children Having Upper GI Endoscopy
Anesthesia, Anxiety
Not yet recruiting
Gastric Emptying After a Yoghurt Breakfast in Children: a Pilot Study
Preoperative Fasting
RecruitingObservational study
ENDoscopic Assessment in Acute PANcreatitis Study (ENDOPAN Study)
Acute Pancreatitis (AP)
Active, not recruiting
Efficacy of EsoGuard Assay on Esophageal Surface Cells Collected With EsoCheck vs EGD for the Diagnosis of BE or EAC
Barrett Esophagus, Esophageal Adenocarcinoma
RecruitingPhase 3
Discontinuation One Week Recommendations for GLP-1 Receptor Agonists Prior to Esophagogastroduodenoscopy.
GLP-1
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yu-Hsi Hsieh, Dr. principal investigator
Dalin Tzu Chi General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Meperidine and normal saline in people with Esophagogastroduodenoscopy, run by Dalin Tzu Chi General Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
discomfort score during esophageal intubation (time frame: 9 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01547520, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Mar 2012.