Propofol Administered by Gastroenterologists by Target Controlled Infusion Pump During Endoscopy (Propofol TCI)

Propofol Administered by Gastroenterologists by Target Controlled Infusion Pump During Endoscopy: a Randomized Double Blind Controlled Study

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.

Study Overview

• Status: Completed
• Conditions: Endoscopy; Sedation
• Intervention / Treatment: Drug: Propofol; Drug: Midazolam

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

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

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 group; 70 patients (35 upper endoscopy - 35 colonoscopy)	Drug: Propofol; 70 patients (35 upper endoscopy - 35 colonoscopy) are sedated with propofol TCI (Target Controlled Infusion) pump (concentration 1.2-1.6 mcg/ml).
Active Comparator: midazolam group; 70 patients (35 upper endoscopy - 35 colonoscopy)	Drug: Midazolam; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time (Minutes) to Dischargeability of Patient From Endoscopic Unit	After endoscopy, patients will be transferred to recovery area and evaluated every 5 minutes until they will be ready to be discharged from the Endoscopy Unit. Recovery will be assessed using the Modified Aldrete Scoring System; patients will be considered fit for discharge with a Modified Aldrete Scoring System score of 18 or more, stable vital signs and without nausea, vomiting, or itching.	one day
Number of Participants With Adverse Events as a Measure of Safety	Number of patients with adverse events (hypotension, bradycardia, hypoxemia,...)	one day

Collaborators and Investigators

• Sponsor: Università Vita-Salute San Raffaele
• Investigators: Study Director: Pier Alberto Testoni, Professor, Vita-Salute San Raffalele University- San Raffaele Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: February 1, 2014
• Primary Completion (Actual): February 1, 2014
• Study Completion (Actual): May 1, 2014

Study Registration Dates

• First Submitted: February 3, 2014
• First Submitted That Met QC Criteria: February 10, 2014
• First Posted (Estimate): February 13, 2014

Study Record Updates

• Last Update Posted (Estimate): September 8, 2014
• Last Update Submitted That Met QC Criteria: August 29, 2014
• Last Verified: August 1, 2014

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: Propofol TCI endoscopy