Health Check up ColonoscopyNCT02039453

Safety and Efficacy of Fentanyl Versus Pethidine During Propofol-based Sedated Colonoscopy: Prospective Randomized Study

A study testing fentanyl doses and pethidine dose in people with Health Check up Colonoscopy, run by Yonsei University at 1 site in South Korea.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

Search all trials

Trial summary

Who is it for?: Ages 20 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Health Check up Colonoscopy
What is being tested?: fentanyl doses and pethidine dose
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 160 participants
Where: 1 siteSouth Korea
Study dates: Sep 2013to Aug 2015
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
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

A patient who undergo screening colonoscopy with sedative agents
A patient over 20 years and under 65 years
A patient who agree to participate in this study

Who cannot join

A patient who is refered from outside hospital to remove previously noted colon polyp
The case who cannot be achieved cecal intubation because of poor bowel preparation
A patient who undergo sedative EGD just prior to colonoscopy
A patient who have allergy to propofol, pethidine, or fentanyl
A patient who have taken MAO inhibitor regularly
A patient who underwent colon resection surgery before colonoscopy

Show all 12Show fewer

A patient who was diagnosed IBD before colonoscopy
Pregnant woman
A patient who cannot maintain sedation level because of significant cardiovascular disease, renal disease, pulmonary disease
A patient who do not agree to participate in this study
A patient who cannot understand this study because of foreigner or retarded mental status
A patient who have lower body weight, less than 37.5kg

Trial locations and contacts

1 site in 1 country.

Sung Pil Hong, MD contact

82-2-2228-1988

sphong@yuhs.ac

South Korea1 site, 1 recruiting

Division of Gastroenterology Department of Internal Medicine, Yonsei University College of Medicine
Seoul, 120-752
Sung Pil Hong, MD, +82-2-2228-1988, sphong@yuhs.ac
Recruiting

Other trials in South Korea

About this study

During sedative colonoscopy, use of propofol have been increased world wide. The onset time of propofol is shorter than midazolam. However the most popular additive pain killer, pethidine show different pharmacodynamic feature. The pethidine has longer onset time than propofol (nearly 30 minutes) and require more time to recovery. For this reason, the use of fentanyl has been increased world widely. However, exact comparison of pethidine and fentanyl was not studied. Therefore, we designed this study to compare both drug to check satisfaction of this drug.

Conditions: Health Check up Colonoscopy
Being tested: fentanyl doses, pethidine dose
Keywords: Colonoscopy, sedation, propofol, fentanyl, pethidine

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

fentanyl dosesDrug
fentanyl doses 50μg (37.5kg to 62.5kg), 75μg (62.5kg to 87.5kg), 100μg (>87.5kg), single use Propofol doses 1.0mg/kg IV bolus loading, 20mg, IV bolus, titration (up to MOAAS 5)
pethidine doseDrug
pethidine dose 50mg, IV bolus (25mg if < 50kg or >70 years or significant co-morbidity), Propofol doses 1.0mg/kg IV bolus loading, 20mg, IV bolus, titration (up to MOAAS 5)

Study groups in NCT02039453
Study group	Role	What they receive
Fentanyl arm	Experimental	The subjects of this arm will consist of the patients who undergo colonoscopy with sedative agents, propofol and fentanyl. Receives: Drug: fentanyl doses
Pethidine arm	Active comparator	The subjects of this arm will consist of the patients who undergo colonoscopy with sedative agents, propofol and pethidine. Receives: Drug: pethidine dose

What is being measured

The primary outcome is the main question the study is designed to answer.

Satisfaction of subjects
From previously reports, both pethidine and fentanyl are safe and effective agents for sedative colonoscopy. Therefore, we will check the subjects' satisfaction of procedure. If patients' satisfaction of procedure under one drug comparing to the others, we will select one drug as pain killer during colonoscopy.
Measured: 1 week later after colonoscopy

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 2013Aug 2015

First posted17 Jan 2014 (estimated)
Study startSep 2013
Primary completionAug 2015 (estimated)
Study completionAug 2015 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (38)Papers the sponsor has linked to this study.
Other trials for Health Check up ColonoscopyStudies of the same condition, open and under way.
More trials run by Yonsei UniversityThe sponsor's other registered studies.
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: Health services research
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Investigator
Enrolment: 160 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02039453
Sponsor's protocol ID: 4-2013-0351
Status last verified: Jan 2014
First submitted: 12 Jan 2014
Last updated: 17 Jan 2014
Results posted: No
Data monitoring committee: No

Publications

Agostoni M, Fanti L, Arcidiacono PG, Gemma M, Strini G, Torri G, Testoni PA. Midazolam and pethidine versus propofol and fentanyl patient controlled sedation/analgesia for upper gastrointestinal tract ultrasound endoscopy: a prospective randomized controlled trial. Dig Liver Dis. 2007 Nov;39(11):1024-9. doi: 10.1016/j.dld.2007.08.004. Epub 2007 Oct 29.
PubMed 17913605
Barriga J, Sachdev MS, Royall L, Brown G, Tombazzi CR. Sedation for upper endoscopy: comparison of midazolam versus fentanyl plus midazolam. South Med J. 2008 Apr;101(4):362-6. doi: 10.1097/SMJ.0b013e318168521b.
PubMed 18360335
Beers R, Camporesi E. Remifentanil update: clinical science and utility. CNS Drugs. 2004;18(15):1085-104. doi: 10.2165/00023210-200418150-00004.
PubMed 15581380
Bilgin H, Basagan Mogol E, Bekar A, Iscimen R, Korfali G. A comparison of effects of alfentanil, fentanyl, and remifentanil on hemodynamic and respiratory parameters during stereotactic brain biopsy. J Neurosurg Anesthesiol. 2006 Jul;18(3):179-84. doi: 10.1097/01.ana.0000210998.10410.2e.
PubMed 16799344
Cinar K, Yakut M, Ozden A. Sedation with midazolam versus midazolam plus meperidine for routine colonoscopy: a prospective, randomized, controlled study. Turk J Gastroenterol. 2009 Dec;20(4):271-5. doi: 10.4318/tjg.2009.0025.
PubMed 20084571
Cohen LB, Hightower CD, Wood DA, Miller KM, Aisenberg J. Moderate level sedation during endoscopy: a prospective study using low-dose propofol, meperidine/fentanyl, and midazolam. Gastrointest Endosc. 2004 Jun;59(7):795-803. doi: 10.1016/s0016-5107(04)00349-9.
PubMed 15173791
Cohen LB, Wecsler JS, Gaetano JN, Benson AA, Miller KM, Durkalski V, Aisenberg J. Endoscopic sedation in the United States: results from a nationwide survey. Am J Gastroenterol. 2006 May;101(5):967-74. doi: 10.1111/j.1572-0241.2006.00500.x.
PubMed 16573781
Dere K, Sucullu I, Budak ET, Yeyen S, Filiz AI, Ozkan S, Dagli G. A comparison of dexmedetomidine versus midazolam for sedation, pain and hemodynamic control, during colonoscopy under conscious sedation. Eur J Anaesthesiol. 2010 Jul;27(7):648-52. doi: 10.1097/EJA.0b013e3283347bfe.
PubMed 20531094
Fakheri HT, Kiasari AZ, Taghvaii T, Hosseini V, Mohammadpour RA, Nasrollah A, Kabirzadeh A, Shahmohammadi S. Assessment the effect of midazolam sedation on hypoxia during upper gastrointestinal endoscopy. Pak J Biol Sci. 2010 Feb 15;13(4):152-7. doi: 10.3923/pjbs.2010.152.157.
PubMed 20437680
Hassan C, Benamouzig R, Spada C, Ponchon T, Zullo A, Saurin JC, Costamagna G. Cost effectiveness and projected national impact of colorectal cancer screening in France. Endoscopy. 2011 Sep;43(9):780-93. doi: 10.1055/s-0030-1256409. Epub 2011 May 27.
PubMed 21623557
Hayee B, Dunn J, Loganayagam A, Wong M, Saxena V, Rowbotham D, McNair A. Midazolam with meperidine or fentanyl for colonoscopy: results of a randomized trial. Gastrointest Endosc. 2009 Mar;69(3 Pt 2):681-7. doi: 10.1016/j.gie.2008.09.033.
PubMed 19251010
Heuss LT, Froehlich F, Beglinger C. Changing patterns of sedation and monitoring practice during endoscopy: results of a nationwide survey in Switzerland. Endoscopy. 2005 Feb;37(2):161-6. doi: 10.1055/s-2004-826143.
PubMed 15692932
Heuss LT, Sugandha SP, Beglinger C. Carbon dioxide accumulation during analgosedated colonoscopy: comparison of propofol and midazolam. World J Gastroenterol. 2012 Oct 14;18(38):5389-96. doi: 10.3748/wjg.v18.i38.5389.
PubMed 23082055
Hoj AT, Vilmann P. [Propofol for sedation during colonoscopy. A survey of a Cochrane review]. Ugeskr Laeger. 2010 May 17;172(20):1532-4. Danish.
PubMed 20483101
Hsieh YH, Chou AL, Lai YY, Chen BS, Sia SL, Chen IC, Chang YL, Lin HJ. Propofol alone versus propofol in combination with meperidine for sedation during colonoscopy. J Clin Gastroenterol. 2009 Sep;43(8):753-7. doi: 10.1097/MCG.0b013e3181862a8c.
PubMed 19169146

Study at a glance

From the registry record, last updated by the sponsor on 17 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Safety and Efficacy of Fentanyl Versus Pethidine During Propofol-based Sedated Colonoscopy: Prospective Randomized Study
ClinicalTrials.gov ID: NCT02039453
Acronym / sponsor ID: 4-2013-0351
Conditions: Health Check up Colonoscopy
Keywords: Colonoscopy, sedation, propofol, fentanyl, pethidine
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 160 participants (estimated)
Lead sponsor: Yonsei UniversityUniversity, hospital or other
Study start: Sep 2013
Primary completion: Aug 2015 (estimated)
Study completion: Aug 2015 (estimated)
First posted: 17 Jan 2014 (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.

Study design

Primary purpose: Health services research
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (investigator)
Number of arms: 2

Arm	Type	Receives
Fentanyl arm	Experimental	Drug: fentanyl dosesThe subjects of this arm will consist of the patients who undergo colonoscopy with sedative agents, propofol and fentanyl.
Pethidine arm	Active comparator	Drug: pethidine doseThe subjects of this arm will consist of the patients who undergo colonoscopy with sedative agents, propofol and pethidine.

Who may qualify

Ages: 20 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

A patient who undergo screening colonoscopy with sedative agents
A patient over 20 years and under 65 years
A patient who agree to participate in this study

Key exclusion criteria (12 listed)

A patient who is refered from outside hospital to remove previously noted colon polyp
The case who cannot be achieved cecal intubation because of poor bowel preparation
A patient who undergo sedative EGD just prior to colonoscopy
A patient who have allergy to propofol, pethidine, or fentanyl
A patient who have taken MAO inhibitor regularly

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
fentanyl dosesfentanyl doses 50μg (37.5kg to 62.5kg), 75μg (62.5kg to 87.5kg), 100μg (>87.5kg), single use Propofol doses 1.0mg/kg IV bolus loading, 20mg, IV bolus, titration (up to MOAAS 5)	Drug	Fentanyl arm
pethidine dosepethidine dose 50mg, IV bolus (25mg if < 50kg or >70 years or significant co-morbidity), Propofol doses 1.0mg/kg IV bolus loading, 20mg, IV bolus, titration (up to MOAAS 5)	Drug	Pethidine arm

Primary outcome

Satisfaction of subjects
Time frame: 1 week later after colonoscopy
From previously reports, both pethidine and fentanyl are safe and effective agents for sedative colonoscopy. Therefore, we will check the subjects' satisfaction of procedure. If patients' satisfaction of procedure under one drug comparing to the others, we will select one drug as pain killer during colonoscopy.

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2014.
Background: PubMed 17913605Agostoni M, Fanti L, Arcidiacono PG, Gemma M, Strini G, Torri G, Testoni PA. Midazolam and pethidine versus propofol and fentanyl patient controlled sedation/analgesia for upper gastrointestinal tract ultrasound endoscopy: a prospective randomized controlled trial. Dig Liver Dis. 2007 Nov;39(11):1024-9. doi: 10.1016/j.dld.2007.08.004. Epub 2007 Oct 29.
Background: PubMed 18360335Barriga J, Sachdev MS, Royall L, Brown G, Tombazzi CR. Sedation for upper endoscopy: comparison of midazolam versus fentanyl plus midazolam. South Med J. 2008 Apr;101(4):362-6. doi: 10.1097/SMJ.0b013e318168521b.
Background: PubMed 15581380Beers R, Camporesi E. Remifentanil update: clinical science and utility. CNS Drugs. 2004;18(15):1085-104. doi: 10.2165/00023210-200418150-00004.
Background: PubMed 16799344Bilgin H, Basagan Mogol E, Bekar A, Iscimen R, Korfali G. A comparison of effects of alfentanil, fentanyl, and remifentanil on hemodynamic and respiratory parameters during stereotactic brain biopsy. J Neurosurg Anesthesiol. 2006 Jul;18(3):179-84. doi: 10.1097/01.ana.0000210998.10410.2e.
Background: PubMed 20084571Cinar K, Yakut M, Ozden A. Sedation with midazolam versus midazolam plus meperidine for routine colonoscopy: a prospective, randomized, controlled study. Turk J Gastroenterol. 2009 Dec;20(4):271-5. doi: 10.4318/tjg.2009.0025.
Background: PubMed 15173791Cohen LB, Hightower CD, Wood DA, Miller KM, Aisenberg J. Moderate level sedation during endoscopy: a prospective study using low-dose propofol, meperidine/fentanyl, and midazolam. Gastrointest Endosc. 2004 Jun;59(7):795-803. doi: 10.1016/s0016-5107(04)00349-9.
Background: PubMed 16573781Cohen LB, Wecsler JS, Gaetano JN, Benson AA, Miller KM, Durkalski V, Aisenberg J. Endoscopic sedation in the United States: results from a nationwide survey. Am J Gastroenterol. 2006 May;101(5):967-74. doi: 10.1111/j.1572-0241.2006.00500.x.
Background: PubMed 20531094Dere K, Sucullu I, Budak ET, Yeyen S, Filiz AI, Ozkan S, Dagli G. A comparison of dexmedetomidine versus midazolam for sedation, pain and hemodynamic control, during colonoscopy under conscious sedation. Eur J Anaesthesiol. 2010 Jul;27(7):648-52. doi: 10.1097/EJA.0b013e3283347bfe.
Background: PubMed 20437680Fakheri HT, Kiasari AZ, Taghvaii T, Hosseini V, Mohammadpour RA, Nasrollah A, Kabirzadeh A, Shahmohammadi S. Assessment the effect of midazolam sedation on hypoxia during upper gastrointestinal endoscopy. Pak J Biol Sci. 2010 Feb 15;13(4):152-7. doi: 10.3923/pjbs.2010.152.157.
Background: PubMed 21623557Hassan C, Benamouzig R, Spada C, Ponchon T, Zullo A, Saurin JC, Costamagna G. Cost effectiveness and projected national impact of colorectal cancer screening in France. Endoscopy. 2011 Sep;43(9):780-93. doi: 10.1055/s-0030-1256409. Epub 2011 May 27.
Background: PubMed 19251010Hayee B, Dunn J, Loganayagam A, Wong M, Saxena V, Rowbotham D, McNair A. Midazolam with meperidine or fentanyl for colonoscopy: results of a randomized trial. Gastrointest Endosc. 2009 Mar;69(3 Pt 2):681-7. doi: 10.1016/j.gie.2008.09.033.
Background: PubMed 15692932Heuss LT, Froehlich F, Beglinger C. Changing patterns of sedation and monitoring practice during endoscopy: results of a nationwide survey in Switzerland. Endoscopy. 2005 Feb;37(2):161-6. doi: 10.1055/s-2004-826143.

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.

Sung Pil Hong, MD contact

82-2-2228-1988

sphong@yuhs.ac

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing fentanyl doses and pethidine dose in people with Health Check up Colonoscopy, run by Yonsei University at 1 site in South Korea.

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 3 inclusion and 12 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: status not confirmed, as of the sponsor's last update on 17 Jan 2014. 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 South Korea. 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. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Sung Pil Hong, MD (82-2-2228-1988, sphong@yuhs.ac), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Satisfaction of subjects (time frame: 1 week later after colonoscopy). 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 NCT02039453, which also lists 38 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 17 Jan 2014.