Atropine-effect During Propofol/Remifentanil Induction

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

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-10-31

Study Completion Date

2013-06-30

Brief Summary

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Remifentanil is a widely used potent intravenous opioid with the advantage of having a short time of action. Compared to other opiates however remifentanil generates more intense hemodynamic side-effects. In ophthalmic surgery the specific anesthesiological challenges necessitate the administration of a combination of relatively high doses of analgesics on the one hand and a short time for postoperative recovery from anesthesia on the other. For these reasons, anesthetic management often consists of a combination of relatively high doses of propofol and remifentanil. A primary concern during this deep propofol/remifentanil anesthesia is preserving hemodynamic stability and adequate tissue oxygenation. Previous research of the investigators group has revealed that atropine has an exceptionally beneficial effect on hemodynamics as well as on tissue oxygenation. Therefore, the investigators hypothesize that administration of intravenous atropine during induction of propofol/remifentanil may have a positive effect on the hemodynamic profile and peripheral and cerebral tissue oxygenation during and after induction of anesthesia.

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Detailed Description

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Conditions

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Anesthesia-induced Negative Hemodynamic Effects

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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General anesthesia + placebo

Propofol/remifentanil anesthesia + saline

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Saline

General anesthesia + atropine

Propofol/remifentanil anesthesia + atropine

Group Type ACTIVE_COMPARATOR

Atropine

Intervention Type DRUG

Atropine

Interventions

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Placebo

Saline

Intervention Type DRUG

Atropine

Intervention Type DRUG

Other Intervention Names

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Saline

Eligibility Criteria

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Inclusion Criteria

* Patients requiring general anaesthesia;
* Patient's age ≥ 18 years and older;
* Patient and surgical procedure appropriate for treatment with either sufentanil or remifentanil.

Exclusion Criteria

* Patient's refusal;
* Pregnancy;
* Patient's age \< 18 years;
* Patients in which atropine is contra-indicated, such as severe aortic valve stenosis, hypertrophic cardiomyopathy or coronary artery disease.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No