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

Propofol Clinical Trial

— PropTCI/2012  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01941888
• Other study ID #: PropTCI2012
• 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

Related Conditions & MeSH terms

• Gastrointestinal Endoscopy
• Moderate Sedation
• Propofol
• Target Controlled Infusion

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