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NCT Number: NCT01941888

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

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).

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Key information

Conditions

Propofol Gastrointestinal Endoscopy Moderate Sedation Target Controlled Infusion

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

San Raffaele Hospital, Milan, Italy

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About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Propofol

Drug

midazolam

Drug

Target Controlled Infusion

Device

Primary outcomes

  1. Endoscopist's VAS (Visual Analog Scale) satisfaction about propofol TCI moderate sedation

    Time frame: one day

    Endoscopist's satisfaction was measured after endoscopic procedures by visual analog scale (VAS 0-100).

  2. Patient's VAS (Visual Analog Scale) satisfactions about propofol TCI moderate sedation

    Time frame: one day

    Patient's satisfactions were measured after endoscopic procedures and 24-48 hours later by visual analog scale (VAS 0-100).

Secondary outcomes

  1. Safety (number of partecipants with adverse events) of propofol TCI moderate sedation

    Time frame: one day

    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.

  2. Time to dischargeability (minutes to reach Modified Aldrete score ≥ 18) of patients

    Time frame: one day

    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.

Sponsors and collaborators

Lead sponsor

Ospedale San Raffaele

Other

Registry information

Official study title

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

Acronym: PropTCI/2012

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Sep 13, 2013
Registry last updated
Sep 13, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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