NCT01489891

Brief Summary

The purpose of this study is to determine the efficacy of application of the anaesthesia topical pharyngeal with lidocaine in esophagogastroduodenoscopy under propofol´s sedation, in therms of dosage and side effect´s reduction overall.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Dec 2011

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2011

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

December 3, 2011

Completed
9 days until next milestone

First Posted

Study publicly available on registry

December 12, 2011

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2012

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2012

Completed
7 months until next milestone

Results Posted

Study results publicly available

March 8, 2013

Completed
Last Updated

March 8, 2013

Status Verified

March 1, 2013

Enrollment Period

7 months

First QC Date

December 3, 2011

Results QC Date

October 29, 2012

Last Update Submit

March 7, 2013

Conditions

Esophagogastroduodenoscopy

Keywords

EsophagogastroduodenoscopyLidocainePropofol

Outcome Measures

Primary Outcomes (1)

  • Rate of Administration of Propofol 1% Required to Obtain Uniform Sedation During Endoscopy

    The propofol will be administered by an expert anaesthetist in repeated bolus (10-20 mg each 30-60 seconds) after an initial induction dosage (0.5-0.6 mg/kg ASA (American Society of Anaesthesiologists) I-II or 0.25-0.35 mg/kg ASA III-IV) to obtain an uniform level of sedation (OAAS 3 and bispectral index (BIS) 70-80) and adequate perceived patient tolerance (no gag-reflex, cough, sudden movements).

    8 months

Secondary Outcomes (3)

  • Percentage of Participants With Adverse Events in Both Groups

    Participants will be followed for the duration of hospital stay, an expected average of 2 hours postprocedure

  • Likert Four Elements Scale to Evaluate the Satisfaction of Endoscopist

    8 months

  • Likert Four Elements Scale to Evaluate the Satisfaction of Anaesthetist

    8 months

Study Arms (2)

Lidocaine group

ACTIVE COMPARATOR

Blinded spraying 50 mg of pharyngeal topical lidocaine 180 seconds before sedated esophagogastroduodenoscopy (EGD)

Drug: Lidocaine

Placebo

PLACEBO COMPARATOR

Excipients without lidocaine. The flavour taste is the same of active comparator ensuring the masking.

Drug: Placebo

Interventions

LidocaineDRUG

Applying of 5 puff controlled released (50 mg) transoral spray of lidocaine (10 mg=1 puff).

Lidocaine group
PlaceboDRUG

Applying of 5 puff controlled released (50 mg) transoral spray of placebo (excipients of trade mark of lidocaine ensuring the patient masking).

Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patient´s over 18 years old that received standard indication for sedated esophagogastroduodenoscopy (American Society of Gastrointestinal Endoscopy Guidelines) in our centre between the period of study.

You may not qualify if:

  • Patients under 18 years old
  • Unable to obtain inform´s consent
  • Emergency endoscopy
  • Pregnant women
  • Encephalopathy
  • Well known allergic reaction to propofol, amide-anaesthesics, soy or eggs
  • Methaemoglobinemia induced factor risks
  • No previous or unknown fasting

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Universitario Infanta Cristina

Parla, Madrid, 28980, Spain

Location

Related Publications (7)

  • Jimenez-Puente G, Hidalgo-Isla M. [Use of topical pharyngeal anaesthesia in esophagogastroduodenoscopy in unsedated patients]. Enferm Clin. 2011 Jan-Feb;21(1):30-4. doi: 10.1016/j.enfcli.2010.07.008. Epub 2011 Feb 18. Spanish.

    PMID: 21334240RESULT

  • Amornyotin S, Srikureja W, Chalayonnavin W, Kongphlay S, Chatchawankitkul S. Topical viscous lidocaine solution versus lidocaine spray for pharyngeal anesthesia in unsedated esophagogastroduodenoscopy. Endoscopy. 2009 Jul;41(7):581-6. doi: 10.1055/s-0029-1214865. Epub 2009 Jul 8.

    PMID: 19588284RESULT

  • 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. doi: 10.1016/j.gie.2005.11.059.

    PMID: 16650534RESULT

  • Lachter J, Jacobs R, Lavy A, Weisler A, Suissa A, Enat R, Eidelman S. Topical pharyngeal anesthesia for easing endoscopy: a double-blind, randomized, placebo-controlled study. Gastrointest Endosc. 1990 Jan-Feb;36(1):19-21. doi: 10.1016/s0016-5107(90)70915-7.

    PMID: 2179038RESULT

  • Mulcahy HE, Greaves RR, Ballinger A, Patchett SE, Riches A, Fairclough PD, Farthing MJ. A double-blind randomized trial of low-dose versus high-dose topical anaesthesia in unsedated upper gastrointestinal endoscopy. Aliment Pharmacol Ther. 1996 Dec;10(6):975-9. doi: 10.1046/j.1365-2036.1996.89261000.x.

    PMID: 8971297RESULT

  • Ristikankare M, Hartikainen J, Heikkinen M, Julkunen R. Is routine sedation or topical pharyngeal anesthesia beneficial during upper endoscopy? Gastrointest Endosc. 2004 Nov;60(5):686-94. doi: 10.1016/s0016-5107(04)02048-6.

    PMID: 15557943RESULT

  • Dumonceau JM, Riphaus A, Aparicio JR, Beilenhoff U, Knape JT, Ortmann M, Paspatis G, Ponsioen CY, Racz I, Schreiber F, Vilmann P, Wehrmann T, Wientjes C, Walder B; NAAP Task Force Members. European Society of Gastrointestinal Endoscopy, European Society of Gastroenterology and Endoscopy Nurses and Associates, and the European Society of Anaesthesiology Guideline: Non-anaesthesiologist administration of propofol for GI endoscopy. Eur J Anaesthesiol. 2010 Dec;27(12):1016-30. doi: 10.1097/EJA.0b013e32834136bf.

    PMID: 21068575RESULT

MeSH Terms

Interventions

Lidocaine

Intervention Hierarchy (Ancestors)

AcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Limitations and Caveats

Unicenter study

Results Point of Contact

Title
Dr. Felipe de la Morena
Organization
Hospital Universitario Infanta Cristina
felipe_de_la_morena@hotmail.com
0034659716030

Study Officials

  • Felipe de la Morena, M.D.

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Gastroenterologist. Head of endoscopy

Study Record Dates

First Submitted

December 3, 2011

First Posted

December 12, 2011

Study Start

December 1, 2011

Primary Completion

July 1, 2012

Study Completion

August 1, 2012

Last Updated

March 8, 2013

Results First Posted

March 8, 2013

Record last verified: 2013-03

Locations

ES(1)