Propofol Administered by Gastroenterologists by Target Controlled Infusion Pump During Endoscopy (Propofol TCI)

Università Vita-Salute San Raffaele

Status and phase: Completed; Phase 4

Conditions: Sedation; Endoscopy

Treatments: Drug: Midazolam; Drug: Propofol

Study type: Interventional

Funder types: Other

Identifiers

NCT02062177

Propofol TCI endoscopy

Details and patient eligibility

About

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.

Enrollment: 140 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

140 participants in 2 patient groups

propofol group

Experimental group

Description:

70 patients (35 upper endoscopy - 35 colonoscopy)

Treatment:

Drug: Propofol

midazolam group

Active Comparator group

Description:

70 patients (35 upper endoscopy - 35 colonoscopy)

Treatment:

Drug: Midazolam