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

Phase 4

Completed

• Conditions: Propofol; Target Controlled Infusion; Moderate Sedation; Gastrointestinal Endoscopy
• Interventions: Drug: Propofol; Drug: Midazolam; Device: Target Controlled Infusion

• Registration Number: NCT01941888
• Lead Sponsor: Ospedale San Raffaele

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).

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 Timeline

• Study Start: 2012-05
• Primary Completion: 2013-03
• Study Completion: 2013-03
• Status Verified: 2013-09
• Study First Submitted: 2013-09-03
• Study First Submitted QC: 2013-09-10
• Last Update Submitted: 2013-09-10
• Study First Posted: 2013-09-13
• Last Update Posted: 2013-09-13

Recruitment & Eligibility

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

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
propofol	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.
propofol	Target Controlled Infusion	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.
midazolam	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.

Primary Outcome Measures

Name	Time	Method
Endoscopist's VAS (Visual Analog Scale) satisfaction about propofol TCI moderate sedation	one day	Endoscopist's satisfaction was measured after endoscopic procedures by visual analog scale (VAS 0-100).
Patient's VAS (Visual Analog Scale) satisfactions about propofol TCI moderate sedation	one day	Patient's satisfactions were measured after endoscopic procedures and 24-48 hours later by visual analog scale (VAS 0-100).

Secondary Outcome Measures

Name	Time	Method
Safety (number of partecipants with adverse events) of propofol TCI moderate sedation	one day	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.
Time to dischargeability (minutes to reach Modified Aldrete score ≥ 18) of patients	one day	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.

Trial Locations

Locations (1)

San Raffaele Hospital; 🇮🇹 Milan, Italy