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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01941888
Other study ID # PropTCI2012
Secondary ID
Status Completed
Phase Phase 4
First received September 3, 2013
Last updated September 10, 2013
Start date May 2012
Est. completion date March 2013

Study information

Verified date September 2013
Source Ospedale San Raffaele
Contact n/a
Is FDA regulated No
Health authority Italy: Ministry of Health
Study type Interventional

Clinical Trial 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).


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).


Recruitment information / eligibility

Status Completed
Enrollment 140
Est. completion date March 2013
Est. primary completion date March 2013
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment


Intervention

Drug:
Propofol

Midazolam

Device:
Target Controlled Infusion


Locations

Country Name City State
Italy San Raffaele Hospital Milan
Italy San Raffaele Hospital Milan

Sponsors (1)

Lead Sponsor Collaborator
Ospedale San Raffaele

Country where clinical trial is conducted

Italy, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 No
Primary 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 No
Secondary 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 Yes
Secondary 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 Yes
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