Propofol Administered by Gastroenterologists by Target Controlled Infusion Pump During Endoscopy

Phase 4

Completed

• Conditions: Endoscopy; Sedation
• Interventions: Drug: Propofol; Drug: Midazolam

• Registration Number: NCT02062177
• Lead Sponsor: Università Vita-Salute San Raffaele

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-02
• Primary Completion: 2014-02
• Study First Submitted: 2014-02-03
• Study First Submitted QC: 2014-02-10
• Study First Posted: 2014-02-13
• Study Completion: 2014-05
• Results First Submitted: 2014-05-13
• Status Verified: 2014-08
• Results First Submitted QC: 2014-08-29
• Last Update Submitted: 2014-08-29
• Results First Posted: 2014-09-08
• Last Update Posted: 2014-09-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 140

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
propofol group	Propofol	70 patients (35 upper endoscopy - 35 colonoscopy)
midazolam group	Midazolam	70 patients (35 upper endoscopy - 35 colonoscopy)

Primary Outcome Measures

Name	Time	Method
Endoscopist's Satisfaction (Visual Analog Scale) About Sedation	at the end of the exam	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
Patient's Satisfaction (Visual Analog Scale) About Sedation Before Discharge	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)
Patient's Satisfaction (Visual Analog Scale) About Sedation 24-72 Hours After Procedure	at 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)

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Adverse Events as a Measure of Safety	one day	Number of patients with adverse events (hypotension, bradycardia, hypoxemia,...)
Time (Minutes) to Dischargeability of Patient From Endoscopic Unit	one day	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.

Trial Locations

Locations (1)

San Raffaele Hospital; 🇮🇹 Milan, Italy