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

S

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

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

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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