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NCT Number: NCT02062177

Propofol Administered by Gastroenterologists by Target Controlled Infusion Pump During Endoscopy

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.

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Key information

Conditions

Sedation Endoscopy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

San Raffaele Hospital

Milan, Italy, 20132

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Propofol

Drug

70 patients (35 upper endoscopy - 35 colonoscopy) are sedated with propofol TCI (Target Controlled Infusion) pump (concentration 1.2-1.6 mcg/ml).

midazolam

Drug

70 patients (35 upper endoscopy - 35 colonoscopy) in group midazolam are sedated with midazolam 0.04 mg/Kg if aged < 70, 0.03 mg/Kg if aged > 70.

Primary outcomes

  1. Endoscopist's Satisfaction (Visual Analog Scale) About Sedation

    Time frame: at the end of the exam

    Visual Analog Scale from 0 to100 (0=dissatisfaction - 100=complete satisfaction) will be used to assess the technical difficulty of examination and the satisfaction with sedation of patient experienced by endoscopist

  2. Patient's Satisfaction (Visual Analog Scale) About Sedation Before Discharge

    Time frame: before discharge

    When completely awake, patients will be asked to rate the degree of pain/discomfort and the degree of satisfaction about quality of sedation from 0 to100 (0=dissatisfaction - 100=complete satisfaction)

  3. Patient's Satisfaction (Visual Analog Scale) About Sedation 24-72 Hours After Procedure

    Time frame: at 24-72 hours after procedure

    Patients will be contacted by telephone 24-72 hours after discharge and asked about their satisfaction about the quality of sedation, rated on a verbal rating scale, from 0 to 100 (0=dissatisfaction; 100=complete satisfaction)

Secondary outcomes

  1. Time (Minutes) to Dischargeability of Patient From Endoscopic Unit

    Time frame: one day

    After endoscopy, patients will be transferred to recovery area and evaluated every 5 minutes until they will be ready to be discharged from the Endoscopy Unit. Recovery will be assessed using the Modified Aldrete Scoring System; patients will be considered fit for discharge with a Modified Aldrete Scoring System score of 18 or more, stable vital signs and without nausea, vomiting, or itching.

  2. Number of Participants With Adverse Events as a Measure of Safety

    Time frame: one day

    Number of patients with adverse events (hypotension, bradycardia, hypoxemia,...)

Sponsors and collaborators

Lead sponsor

Università Vita-Salute San Raffaele

Other

Registry information

Official study title

Propofol Administered by Gastroenterologists by Target Controlled Infusion Pump During Endoscopy: a Randomized Double Blind Controlled Study

Acronym: Propofol TCI

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Feb 13, 2014
Registry last updated
Sep 8, 2014

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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