Propofol TCI Administered by Gastroenterologists During Endoscopy: a Randomized Double Blind Controlled Study

NCT01941888 | Completed Phase 4 DMC

• 1 other identifier: PropTCI2012
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 2

Brief Summary

Many studies address safety and effectiveness of non-anesthesiologist propofol sedation (NAPS) for GI endoscopy. Target Controlled Infusion (TCI) is a sophisticated tool for providing optimal sedation regimen and avoiding under or oversedation. This randomized double blind controlled study compares standard moderate sedation level of sedation (group S) during upper endoscopy (EGD) and colonoscopy (CS) versus propofol NAPS (group P).

Conditions

Propofol; Target Controlled Infusion; Moderate Sedation; Gastrointestinal Endoscopy

Outcome Measures

Primary Outcomes (2)

• Endoscopist's VAS (Visual Analog Scale) satisfaction about propofol TCI moderate sedation

  Endoscopist's satisfaction was measured after endoscopic procedures by visual analog scale (VAS 0-100).

  one day

• Patient's VAS (Visual Analog Scale) satisfactions about propofol TCI moderate sedation

  Patient's satisfactions were measured after endoscopic procedures and 24-48 hours later by visual analog scale (VAS 0-100).

  one day

Secondary Outcomes (2)

• Safety (number of partecipants with adverse events) of propofol TCI moderate sedation

  one day

• Time to dischargeability (minutes to reach Modified Aldrete score ≥ 18) of patients

  one day

Study Arms (2)

propofol

EXPERIMENTAL

Patients in Group Propofol(n=70) were seated with propofol target concentration 1.2-1.6 µg/ml. Patients in both groups undergoing CS received also iv fentanyl (1μg/Kg) for pain control.

Drug: Propofol; Device: Target Controlled Infusion

midazolam

ACTIVE COMPARATOR

Control Group: patients in Group midazolam (n=70) were sedated with midazolam 0.04 mg/kg if aged\< 70 - 0.03 mg/kg if aged\> 70. Patients in both groups undergoing CS received also iv fentanyl (1μg/Kg) for pain control.

Drug: Midazolam

Interventions

Propofol DRUG

propofol

Midazolam DRUG

midazolam

Target Controlled Infusion DEVICE

propofol

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age \>18 yrs
• ASA (American Society of Anesthesiologists risk class III-IV)I-II
• patients undergoing to gastroscopy or colonoscopy

You may not qualify if:

• significant systemic disease (American Society of Anesthesiologists risk class III-IV)
• history of allergic reactions to any of the study drugs
• chronic use of opioid analgesics
• psychiatric disorder
• pregnancy
• difficult airways (Mallampati score \>2)
• age \<18 yrs

Sponsors & Collaborators

• Ospedale San Raffaele: lead

Study Sites (2)

San Raffaele Hospital

Milan, Milan, 20132, Italy

Location

San Raffaele Hospital

Milan, Italy

Location

MeSH Terms

Interventions

Propofol; Midazolam

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Massimo Agostoni, MD

  San Raffele Hospital

  STUDY DIRECTOR

• Lorella Fanti, MD

  San Raffaele Hospital

  PRINCIPAL INVESTIGATOR

• Marco Gemma, MD

  San Raffaele Hospital

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: September 3, 2013
• First Posted: September 13, 2013
• Study Start: May 1, 2012
• Primary Completion: March 1, 2013
• Study Completion: March 1, 2013
• Last Updated: September 13, 2013

Record last verified: 2013-09

Locations

IT (2)