NCT02062177

Brief Summary

Many studies address safety of non-anesthesiologist propofol sedation (NAPS) for gastrointestinal endoscopy. Target Controlled Infusion (TCI) is a sophisticated tool for providing optimal sedation regimen and avoiding under or oversedation. The objective of the study is to compare standard moderate sedation during upper endoscopy and colonoscopy versus propofol NAPS.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
140

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Feb 2014

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

February 1, 2014

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2014

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

February 3, 2014

Completed
10 days until next milestone

First Posted

Study publicly available on registry

February 13, 2014

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2014

Completed
4 months until next milestone

Results Posted

Study results publicly available

September 8, 2014

Completed
Last Updated

September 8, 2014

Status Verified

August 1, 2014

Enrollment Period

Same day

First QC Date

February 3, 2014

Results QC Date

May 13, 2014

Last Update Submit

August 29, 2014

Conditions

SedationEndoscopy

Outcome Measures

Primary Outcomes (3)

  • Endoscopist's Satisfaction (Visual Analog Scale) About Sedation

    Visual Analog Scale from 0 to100 (0=dissatisfaction - 100=complete satisfaction) will be used to assess the technical difficulty of examination and the satisfaction with sedation of patient experienced by endoscopist

    at the end of the exam

  • Patient's Satisfaction (Visual Analog Scale) About Sedation Before Discharge

    When completely awake, patients will be asked to rate the degree of pain/discomfort and the degree of satisfaction about quality of sedation from 0 to100 (0=dissatisfaction - 100=complete satisfaction)

    before discharge

  • Patient's Satisfaction (Visual Analog Scale) About Sedation 24-72 Hours After Procedure

    Patients will be contacted by telephone 24-72 hours after discharge and asked about their satisfaction about the quality of sedation, rated on a verbal rating scale, from 0 to 100 (0=dissatisfaction; 100=complete satisfaction)

    at 24-72 hours after procedure

Secondary Outcomes (2)

  • Time (Minutes) to Dischargeability of Patient From Endoscopic Unit

    one day

  • Number of Participants With Adverse Events as a Measure of Safety

    one day

Study Arms (2)

propofol group

EXPERIMENTAL

70 patients (35 upper endoscopy - 35 colonoscopy)

Drug: Propofol

midazolam group

ACTIVE COMPARATOR

70 patients (35 upper endoscopy - 35 colonoscopy)

Drug: Midazolam

Interventions

PropofolDRUG

70 patients (35 upper endoscopy - 35 colonoscopy) are sedated with propofol TCI (Target Controlled Infusion) pump (concentration 1.2-1.6 mcg/ml).

propofol group
MidazolamDRUG

70 patients (35 upper endoscopy - 35 colonoscopy) in group midazolam are sedated with midazolam 0.04 mg/Kg if aged \< 70, 0.03 mg/Kg if aged \> 70.

midazolam group

Eligibility Criteria

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

You may qualify if:

  • age \< 18 years
  • American Society of Anesthesiologists risk I-II
  • patients undergoing to Gastroscopy or Colonoscopy

You may not qualify if:

  • significant systemic disease
  • allergic reactions to any of study drugs
  • chronic use of opioids or psychiatric disorders
  • pregnancy
  • Mallampati score \> 2
  • age \< 18 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

San Raffaele Hospital

Milan, Italy, 20132, Italy

Location

Related Publications (1)

  • Fanti L, Gemma M, Agostoni M, Rossi G, Ruggeri L, Azzolini ML, Dabizzi E, Beretta L, Testoni PA. Target Controlled Infusion for non-anaesthesiologist propofol sedation during gastrointestinal endoscopy: The first double blind randomized controlled trial. Dig Liver Dis. 2015 Jul;47(7):566-71. doi: 10.1016/j.dld.2015.03.003. Epub 2015 Mar 14.

    PMID: 25840875DERIVED

MeSH Terms

Interventions

PropofolMidazolam

Intervention Hierarchy (Ancestors)

PhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsBenzodiazepinesBenzazepinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Results Point of Contact

Title
Professor Testoni Pier Alberto
Organization
Università Vita-Salute San Raffaele
testoni.pieralberto@hsr.it
+390226432756

Study Officials

  • Pier Alberto Testoni, Professor

    Vita-Salute San Raffalele University- San Raffaele Hospital

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 3, 2014

First Posted

February 13, 2014

Study Start

February 1, 2014

Primary Completion

February 1, 2014

Study Completion

May 1, 2014

Last Updated

September 8, 2014

Results First Posted

September 8, 2014

Record last verified: 2014-08

Locations

IT(1)