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

NCT ID: NCT01941888

Last Updated: 2013-09-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-05-31

Study Completion Date

2013-03-31

Brief Summary

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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).

Detailed Description

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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).

Conditions

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Propofol Target Controlled Infusion Moderate Sedation Gastrointestinal Endoscopy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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propofol

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.

Group Type EXPERIMENTAL

Propofol

Intervention Type DRUG

Target Controlled Infusion

Intervention Type DEVICE

midazolam

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.

Group Type ACTIVE_COMPARATOR

Midazolam

Intervention Type DRUG

Interventions

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Propofol

Intervention Type DRUG

Midazolam

Intervention Type DRUG

Target Controlled Infusion

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ospedale San Raffaele

OTHER

Sponsor Role lead

Responsible Party

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Agostoni Massimo

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Massimo Agostoni, MD

Role: STUDY_DIRECTOR

San Raffele Hospital

Lorella Fanti, MD

Role: PRINCIPAL_INVESTIGATOR

San Raffaele Hospital

Marco Gemma, MD

Role: PRINCIPAL_INVESTIGATOR

San Raffaele Hospital

Locations

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San Raffaele Hospital

Milan, Milan, Italy

Site Status

San Raffaele Hospital

Milan, , Italy

Site Status

Countries

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Italy

Other Identifiers

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PropTCI2012

Identifier Type: -

Identifier Source: org_study_id