Inhaled Sevofluran vs Endovenous Propofol for Colonoscopy

NCT ID: NCT03818048

Last Updated: 2019-01-28

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

NA

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-01

Study Completion Date

2016-12-28

Brief Summary

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To compare the anesthetic efficacy of the inhalation versus intravenous technique for maintenance of sedation in patients undergoing endoscopy.

A longitudinal, randomized clinical study of 32 patients of both sexes ASA I-III, aged 18-80 years undergoing diagnostic colonoscopy, which was randomly divided into 2 groups. In both, intravenous induction with propofol (2-2.5 mg / kg) was performed, Group A remained sedated with propofol infusion (1-2 mg / kg / min); Group B by inhalation with sevoflurane at a concentration of 2 vol% through a nasal cannula with an oxygen flow.

Detailed Description

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Conditions

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Anesthesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Group Propofol

propofol infusion

Group Type EXPERIMENTAL

Propofol

Intervention Type DRUG

after inicial bolus of propofol, remained sedated with propofol infusion (1-2 mg/kg/min)

Group Sevoflurane

inhalation with sevoflurane

Group Type EXPERIMENTAL

Sevoflurane

Intervention Type DRUG

after inicial bolus of propofol, remained sedated by inhalation with sevoflurane at a concentration of 2 vol% through a nasal cannula with an oxygen flow.

Interventions

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Propofol

after inicial bolus of propofol, remained sedated with propofol infusion (1-2 mg/kg/min)

Intervention Type DRUG

Sevoflurane

after inicial bolus of propofol, remained sedated by inhalation with sevoflurane at a concentration of 2 vol% through a nasal cannula with an oxygen flow.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Age between 18 and 80 years
* physical status I, II and III according to the criteria of the American Society of Anesthesiology (ASA)
* patients who are going to undergo diagnostic colonoscopies
* patients who signed the informed consent

Exclusion Criteria

* Allergy or hypersensitivity to some of the reference drugs in the study
* patients with proven liver disease
* suspicion or confirmation of pregnancy
* antecedent or risk of malignant hyperthermia
* fasting less than 8 hours
* patients with psychic disorders or mental incapacity that make it difficult to understand their participation in the study
* patients who have acute illnesses that compromise their health for which the study cannot be performed
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centro Medico Docente la Trinidad

OTHER

Sponsor Role lead

Responsible Party

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Leopoldo Wulff

Principal Investigator, anesthesiologist.

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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CMDLT

Identifier Type: -

Identifier Source: org_study_id

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