Propofol TCI Administered by Gastroenterologists During Endoscopy: a Randomized Double Blind Controlled Study (PropTCI/2012)

San Donato Group (GSD)

Status and phase: Completed; Phase 4

Conditions: Moderate Sedation; Gastrointestinal Endoscopy; Propofol; Target Controlled Infusion

Treatments: Drug: Propofol; Drug: Midazolam; Device: Target Controlled Infusion

Study type: Interventional

Funder types: Other

Identifiers

NCT01941888

PropTCI2012

Details and patient eligibility

About

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).

Full 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).

Enrollment: 140 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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140 participants in 2 patient groups

propofol

Experimental group

Description:

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.

Treatment:

Drug: Propofol

Device: Target Controlled Infusion

midazolam

Active Comparator group

Description:

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.

Treatment:

Drug: Midazolam