NCT03607110

Brief Summary

In sedation applications performed by an endoscopist or anesthetist during colonoscopy, it was investigated whether there were differences in pain levels evaluated by VAS (Visuel analog scale), patient satisfaction, duration of procedure and side effects

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 all trials

Timeline
Completed

Started Mar 2018

Shorter than P25 for all trials

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

March 1, 2018

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2018

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 13, 2018

Completed
18 days until next milestone

First Posted

Study publicly available on registry

July 31, 2018

Completed
Last Updated

July 31, 2018

Status Verified

July 1, 2018

Enrollment Period

3 months

First QC Date

July 13, 2018

Last Update Submit

July 23, 2018

Conditions

ColonoscopyKetamineFentanyl

Outcome Measures

Primary Outcomes (2)

  • pain level - VAS SCALE

    Pain level assessed by VAS

    during the operation

  • patient satisfaction - Patient satisfaction Scale

    patient satisfaction assessed by with satisfaction score of 4 points-scale (1 very good, 2 good, 3 not bad, 4 bad)

    during the operation

Secondary Outcomes (2)

  • operation time

    during the operation

  • side effects questionnaire

    during the operation

Study Arms (2)

ketamine

ketamine used

Drug: KetamineDevice: patient control analgesia

fentanyl

fentanyl used

Drug: fentanylDevice: patient control analgesia

Interventions

KetamineDRUG

sedation drugs

ketamine
fentanylDRUG

sedation drugs

fentanyl
patient control analgesiaDEVICE

patient control analgesia

fentanylketamine

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

colonoscopy patients with ASA I-II group

You may qualify if:

  • Patients who accept the method and will undergo elective colonoscopy
  • ASA I-II group
  • Patients with the ability to perform VAS scoring

You may not qualify if:

  • Patients who do not accept the method
  • ASA III-IV-V group of patients with uncontrolled chronic disease (such as uncontrolled hypertension, uncontrolled diabetes mellitus)
  • Patients with severe respiratory failure and cardiovascular disease
  • Patients with liver and kidney failure
  • Patients with long-term analgesic, opioid, sedative use history - Patients who are known to be hypersensitive to study medications, eggs,
  • Those who are of pregnancy or pregnancy and those who are in breastfeeding period
  • Those with antipsychotic or antidepressant medication usage

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Develi Hatice Muammer Kocatürk Devlet Hastanesi

Develi, Kayseri, Turkey (Türkiye)

Location

Related Publications (5)

  • Ferreira AO, Cravo M. Sedation in gastrointestinal endoscopy: Where are we at in 2014? World J Gastrointest Endosc. 2015 Feb 16;7(2):102-9. doi: 10.4253/wjge.v7.i2.102.

    PMID: 25685266BACKGROUND

  • Dal H., S. İzdeş, E. Kesimci, et al. Kolonoskopide sedasyon için propofolün aralıklı bolus veya hedef kontrollü infüzyon yöntemiyle uygulanmasının karşılaştırılması, Türk Anest Rean Der Dergisi, 2011; 39(3): 134-142

    BACKGROUND

  • Lee DW, Chan AC, Sze TS, Ko CW, Poon CM, Chan KC, Sin KS, Chung SC. Patient-controlled sedation versus intravenous sedation for colonoscopy in elderly patients: a prospective randomized controlled trial. Gastrointest Endosc. 2002 Nov;56(5):629-32. doi: 10.1067/mge.2002.128919.

    PMID: 12397267BACKGROUND

  • Poincloux L, Laquiere A, Bazin JE, Monzy F, Artigues F, Bonny C, Abergel A, Dapoigny M, Bommelaer G. A randomized controlled trial of endoscopist vs. anaesthetist-administered sedation for colonoscopy. Dig Liver Dis. 2011 Jul;43(7):553-8. doi: 10.1016/j.dld.2011.02.007. Epub 2011 Mar 29.

    PMID: 21450542BACKGROUND

  • Crepeau T, Poincloux L, Bonny C, Lighetto S, Jaffeux P, Artigue F, Walleckx P, Bazin JE, Dapoigny M, Bommelaer G. Significance of patient-controlled sedation during colonoscopy. Results from a prospective randomized controlled study. Gastroenterol Clin Biol. 2005 Nov;29(11):1090-6. doi: 10.1016/s0399-8320(05)82172-4.

    PMID: 16505753BACKGROUND

MeSH Terms

Interventions

KetamineFentanyl

Intervention Hierarchy (Ancestors)

CyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Anesthesia and Reanimation Specialist

Study Record Dates

First Submitted

July 13, 2018

First Posted

July 31, 2018

Study Start

March 1, 2018

Primary Completion

June 1, 2018

Study Completion

June 1, 2018

Last Updated

July 31, 2018

Record last verified: 2018-07

Locations

TU(1)