Propofol TCI Administered by Gastroenterologists During Endoscopy: a Randomized Double Blind Controlled Study (PropTCI/2012)

Phase IV Study of Propofol TCI (Target Controlled Infusion)Administered by Gastroenterologists During Endoscopy in Moderate Sedation: a Randomized Double Blind Controlled Study

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).

Study Overview

• Status: Completed
• Conditions: Gastrointestinal Endoscopy; Propofol; Target Controlled Infusion; Moderate Sedation
• Intervention / Treatment: Drug: Midazolam; Drug: Propofol; Device: Target Controlled Infusion

Detailed Description

70 CS and 70 EGD ASA I-II patients were studied. In group S (n=70) we administered fentanyl (1μg/kg) + midazolam (0.04-0.03 mg/kg) for CS and midazolam (0.04-0.03 mg/kg) for EGDS and in group P (n=70) fentanyl 1µg/Kg + propofol TCI 1.2-1.6 μg/ml for CS and propofol TCI 1.2-1.6 μg/ml for EGD. Vital parameters and Observer's Assessment of Alertness and Sedation Scale (OAA/S) were monitored throughout the study. Endoscopist's and patient's satisfactions were measured after procedure and 24-72 h later by visual analog scale (VAS).

• Study Type: Interventional
• Enrollment (Actual): 140
• Phase: Phase 4

Contacts and Locations

Study Locations

• Italy
  • Milan, Italy, 20132
    • San Raffaele Hospital
  • Milan, Italy
    • San Raffaele Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: propofol; 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
Active Comparator: midazolam; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety (number of partecipants with adverse events) of propofol TCI moderate sedation	To compare safety (number of partecipants with adverse events) of propofol TCI versus midazolam iv boluses during upper endoscopy (EGD) and colonoscopy (CS). Both sedation regimens were administered by endoscopists.	one day
Time to dischargeability (minutes to reach Modified Aldrete score ≥ 18) of patients	To compare time to dischargeability (minutes to reach Modified Aldrete score ≥ 18) of patients in group standard versus propofol TCI group safety (number of partecipants with adverse events) of propofol TCI versus midazolam iv boluses during upper endoscopy (EGD) and colonoscopy (CS). Both sedation regimens were administered by endoscopists.	one day

Collaborators and Investigators

• Sponsor: Ospedale San Raffaele
• Investigators: Study Director: Massimo Agostoni, MD, San Raffele Hospital; Principal Investigator: Lorella Fanti, MD, San Raffaele Hospital; Principal Investigator: Marco Gemma, MD, San Raffaele Hospital

Study record dates

Study Major Dates

• Study Start: May 1, 2012
• Primary Completion (Actual): March 1, 2013
• Study Completion (Actual): March 1, 2013

Study Registration Dates

• First Submitted: September 3, 2013
• First Submitted That Met QC Criteria: September 10, 2013
• First Posted (Estimate): September 13, 2013

Study Record Updates

• Last Update Posted (Estimate): September 13, 2013
• Last Update Submitted That Met QC Criteria: September 10, 2013
• Last Verified: September 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Tranquilizing Agents; Psychotropic Drugs; Hypnotics and Sedatives; Adjuvants, Anesthesia; Anti-Anxiety Agents; GABA Modulators; GABA Agents; Midazolam; Propofol
• Other Study ID Numbers: PropTCI2012