Propofol Administered by Gastroenterologists by Target Controlled Infusion Pump During Endoscopy

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-02-28

Study Completion Date

2014-05-31

Brief Summary

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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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Detailed Description

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Conditions

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Sedation Endoscopy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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propofol group

70 patients (35 upper endoscopy - 35 colonoscopy)

Group Type EXPERIMENTAL

Propofol

Intervention Type 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 group

70 patients (35 upper endoscopy - 35 colonoscopy)

Group Type ACTIVE_COMPARATOR

Midazolam

Intervention Type 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.

Interventions

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Propofol

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

Intervention Type DRUG

Midazolam

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.

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No