Trial record 5 of 9 for: "Hematemesis"

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Efficacy Study of Articaine Lozenge to Enhance the Procedural Compliance of the Adults Undergoing Gastroduodenoscopy

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.

Verified October 2014 by Mihkel Meinberg, Helsinki University Central Hospital.
Recruitment status was: Recruiting

Sponsor:

Information provided by (Responsible Party):

Mihkel Meinberg, Helsinki University Central Hospital

ClinicalTrials.gov Identifier:

NCT02105090

First received: March 29, 2014

Last updated: October 8, 2014

Last verified: October 2014

History of Changes

Purpose

The purpose of this study is to examine in prospective, double-blinded randomised manner the ability of novel articaine-containing lozenge to enhance the procedure related compliance (compared to placebo) of the adult patients undergoing upper gastrointestinal endoscopy.

Condition	Intervention	Phase
Dyspepsia Hematemesis Abdominal Pain Heartburn	Drug: Anesthetics, Local Drug: Sodium Chloride 0.9%	Phase 4


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Participant, Care Provider, Investigator) Primary Purpose: Treatment
Official Title:	Comparison of Novel Articaine Lozenge Versus Placebo for Upper Gastrointestinal Endoscopy in Adults. A Randomized Double-blinded Controlled Study

Resource links provided by NLM:

MedlinePlus related topics: Endoscopy

Drug Information available for: Sodium chloride Articaine hydrochloride Articaine Septocaine

U.S. FDA Resources

Further study details as provided by Mihkel Meinberg, Helsinki University Central Hospital:

Primary Outcome Measures:

Percentage of participants with 15% change in tolerability points according to Numeric Rating Scale (compared to baseline Numeric Rating Scale). [ Time Frame: 30 minutes after the procedure ]

Secondary Outcome Measures:

Endoscopists´ procedural satisfaction points after the procedure assessed by using Numeric Rating Scale (NRS) [ Time Frame: within 30 minutes after the procedure ]
Cumulative consumption of alfentanil during the procedure (mg) [ Time Frame: 30 minutes after the procedure ]


Estimated Enrollment:	120
Study Start Date:	October 2014
Estimated Study Completion Date:	December 2015
Estimated Primary Completion Date:	June 2015 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Placebo Comparator: Sodium chloride 0.9% Sodium chloride 0.9% flavoured lozenge 10 ml administered orally (gargled and swallowed by patient) 3 minutes before the upper GI endoscopy	Drug: Sodium Chloride 0.9%
Experimental: Articaine hydrochloride 1% Articaine hydrochloride 1% flavoured lozenge 10 ml administered orally (gargled and swallowed by patient) 3 minutes before the upper GI endoscopy	Drug: Anesthetics, Local Other Name: Ultracain D ohne Adrenalin 20 mg/ml, ATC code N01BB08
Experimental: Articaine hydrochloride 2% Articaine hydrochloride 2% flavoured lozenge 10 ml administered orally (gargled and swallowed by patient) 3 minutes before the upper GI endoscopy	Drug: Anesthetics, Local Other Name: Ultracain D ohne Adrenalin 20 mg/ml, ATC code N01BB08

Eligibility


Ages Eligible for Study:	20 Years to 75 Years (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

elective procedure
weight over 40 kg
American Society of Anesthesiology class I-III
first upper GI endoscopy procedure
finnish or/and swedish speaking

Exclusion Criteria:

amide and/or esther local anaesthetic allergy
paraben allergy
Child-Pugh grade B/C liver failure
renal insufficiency (calculated glomerular filtration rate under 60 ml/min/1.73 m2 according to Cockcroft-Gault scale )
dementia
those presenting with swallowing problem
chronic pain condition
chronic use of pain medication
pregnancy
lactation

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02105090

Contacts


Contact: Mihkel Meinberg, MD	+358504286766	mihkel.meinberg@hus.fi
Contact: Reino Pöyhiä, MD, PhD	+35894711	reino.poyhia@hus.fi

Locations


Finland
Department of Anesthesiology and Intensive care medicine, Divison of Surgery, Meilahti hospital, Helsinki University Central Hospital	Recruiting
Helsinki, Uusimaa, Finland, 00029
Contact: Mihkel Meinberg, MD +358504286766 mihkel.meinberg@hus.fi
Contact: Reino Pöyhiä, MD, PhD +35894711 reino.poyhia@hus.fi
Principal Investigator: Mihkel Meinberg, MD
Sub-Investigator: Kalle Jokelainen, MD, PhD
Sub-Investigator: Harri Mustonen, MD, PhD
Sub-Investigator: Hannamari Hakojärvi, Pharm.D
Sub-Investigator: Anne Juppo, Pharm.D, PhD
Sub-Investigator: Pertti Pere, MD, PhD

Sponsors and Collaborators

Helsinki University Central Hospital

Investigators


Principal Investigator:	Mihkel Meinberg, MD	Department of Anesthesiology and Intensive care medicine, Division of Surgery, Meilahti Hospital, Helsinki University Central Hospital
Study Chair:	Reino Pöyhiä, MD, PhD	Department of Anesthesiology and Intensive care medicine, Division of Surgery, Meilahti Hospital, Helsinki University Central Hospital

More Information

Publications:

Campo R, Brullet E, Montserrat A, Calvet X, Moix J, Rué M, Roqué M, Donoso L, Bordas JM. Identification of factors that influence tolerance of upper gastrointestinal endoscopy. Eur J Gastroenterol Hepatol. 1999 Feb;11(2):201-4.

Davis DE, Jones MP, Kubik CM. Topical pharyngeal anesthesia does not improve upper gastrointestinal endoscopy in conscious sedated patients. Am J Gastroenterol. 1999 Jul;94(7):1853-6.

Shaoul R, Higaze H, Lavy A. Evaluation of topical pharyngeal anaesthesia by benzocaine lozenge for upper endoscopy. Aliment Pharmacol Ther. 2006 Aug 15;24(4):687-94.

Evans LT, Saberi S, Kim HM, Elta GH, Schoenfeld P. Pharyngeal anesthesia during sedated EGDs: is "the spray" beneficial? A meta-analysis and systematic review. Gastrointest Endosc. 2006 May;63(6):761-6. Review.

Asante MA, Northfield TC. Variation in taste of topical lignocaine anaesthesia for gastroscopy. Aliment Pharmacol Ther. 1998 Jul;12(7):685-6.

Mogensen S, Treldal C, Feldager E, Pulis S, Jacobsen J, Andersen O, Rasmussen M. New lidocaine lozenge as topical anesthesia compared to lidocaine viscous oral solution before upper gastrointestinal endoscopy. Local Reg Anesth. 2012;5:17-22. doi: 10.2147/LRA.S30715. Epub 2012 May 31.

Vree TB, Gielen MJ. Clinical pharmacology and the use of articaine for local and regional anaesthesia. Best Pract Res Clin Anaesthesiol. 2005 Jun;19(2):293-308. Review.

Brinklov MM. Clinical effects of carticaine, a new local anesthetic. A survey and a double-blind investigation comparing carticaine with lidocaine in epidural analgesia. Acta Anaesthesiol Scand. 1977;21(1):5-16.

Kallio H, Snäll EV, Luode T, Rosenberg PH. Hyperbaric articaine for day-case spinal anaesthesia. Br J Anaesth. 2006 Nov;97(5):704-9. Epub 2006 Aug 5.

Pitkänen MT, Xu M, Haasio J, Rosenberg PH. Comparison of 0.5% articaine and 0.5% prilocaine in intravenous regional anesthesia of the arm: a cross-over study in volunteers. Reg Anesth Pain Med. 1999 Mar-Apr;24(2):131-5.

Simon MA, Vree TB, Gielen MJ, Booij LH, Lagerwerf AJ. Similar motor block effects with different disposition kinetics between lidocaine and (+ or -) articaine in patients undergoing axillary brachial plexus block during day case surgery. Int J Clin Pharmacol Ther. 1999 Dec;37(12):598-607.

Vree TB, Baars AM, van Oss GE, Booij LH. High-performance liquid chromatography and preliminary pharmacokinetics of articaine and its 2-carboxy metabolite in human serum and urine. J Chromatogr. 1988 Feb 26;424(2):440-4.

Prout BJ, Metreweli C. Pulmonary aspiration after fibre-endoscopy of the upper gastrointestinal tract. Br Med J. 1972 Nov 4;4(5835):269-71.

Oertel R, Rahn R, Kirch W. Clinical pharmacokinetics of articaine. Clin Pharmacokinet. 1997 Dec;33(6):417-25. Review.

Simon MA, Vree TB, Gielen MJ, Booij LH. Comparison of the effects and disposition kinetics of articaine and lidocaine in 20 patients undergoing intravenous regional anaesthesia during day case surgery. Pharm World Sci. 1998 Apr;20(2):88-92.

Alhashemi JA. Dexmedetomidine vs midazolam for monitored anaesthesia care during cataract surgery. Br J Anaesth. 2006 Jun;96(6):722-6. Epub 2006 Apr 4.


Responsible Party:	Mihkel Meinberg, MD, Helsinki University Central Hospital
ClinicalTrials.gov Identifier:	NCT02105090 History of Changes
Other Study ID Numbers:	2012-005528-13
Study First Received:	March 29, 2014
Last Updated:	October 8, 2014

Keywords provided by Mihkel Meinberg, Helsinki University Central Hospital:


Upper gastrointestinal tract Endoscopy Lozenge Articaine	Dyspepsia Hematemesis Abdominal pain Heartburn

Additional relevant MeSH terms:


Hematemesis Dyspepsia Abdominal Pain Heartburn Signs and Symptoms, Digestive Signs and Symptoms Pain Neurologic Manifestations Nervous System Diseases Gastrointestinal Hemorrhage Gastrointestinal Diseases	Digestive System Diseases Hemorrhage Pathologic Processes Vomiting Anesthetics Carticaine Anesthetics, Local Central Nervous System Depressants Physiological Effects of Drugs Sensory System Agents Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on July 14, 2017

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