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Hypotensive Effect of Anaesthesia With TCI

NCT ID: NCT02733406

Last Updated: 2017-10-26

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

76 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-04-30

Study Completion Date

2017-08-31

Brief Summary

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Hypotension will often complicate induction of anaesthesia. The investigators want to test the hypothesis that Target Controlled Infusion, as opposed to Velocity Controlled Infusion, leads to less degree of hypotension.

Detailed Description

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Severe hypotension may be a serious complication to induction of anaesthesia. The patients preoperative clinical circulatory status will help define the risks of such a side-effect. A patient with a preexisting heart condition will be at increased risk for morbidity/mortality in relation to anaesthesia induction.

Total intravenous anaesthesia may be delivered by two different approaches. The old way where the drug (Propofol and/or Remifentanil) is delivered in a velocity (mg/kg x hour or microg/ kg x min) specified by the anaesthetist. Hereafter called Velocity Controlled Infusion (VCI). At induction, to get effect of the drug, a high infusion rate is desired. A high infusion rate is associated with increased risks of hypotension if it is not adjusted in accordance with the current circulatory status of the patient. A failure to adjust may be futile for the patient. Therefore, induction takes some time because infusion rate is set within a relatively safe range. After a few minutes, once airway control is achieved, the infusion rate must be adjusted down to avoid hypotension.

There is a more modern way of adjusting the infusion rate, the so called Target Controlled Infusion. With this approach, the pump delivering the drug will help the anaesthetist to select the appropriate infusion rate for any given situation. The anaesthetist selects a preferred concentration of the drug at the target, that is in the circulation. The pump then administrates the drug, first at high rate and then at lower rate, taking into account the patients age, weight and sex and the preferred target concentration.

It is possible that this help from the machine is associated with less risk for hypotension at anaesthesia induction. If this is so it would have an impact on which of TCI and VCI that would be the best choice of anaesthesia. This would have special impact when giving anaesthesia to patients with a heart condition.

Conditions

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Blood Pressure Hypotension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Participants

Study Groups

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Target Controlled Infusion

This group of patients will have their anaesthesia induced with Target Controlled Infusion (TCI)

Group Type OTHER

Target Controlled Infusion

Intervention Type OTHER

Velocity Controlled Infusion

This group of patients will have their anaesthesia induced with Velocity Controlled Infusion (VCI)

Group Type OTHER

Velocity Controlled Infusion

Intervention Type OTHER

Interventions

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Target Controlled Infusion

Intervention Type OTHER

Velocity Controlled Infusion

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

\* All patients scheduled for anaesthesia at Östersunds Hospital

* ASA class I-II

Exclusion Criteria

* On beforehand decision to start continous delivery of blood pressure increasing drug at induction.
* Any contraindication to Total Intravenous Anaesthesia
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Umeå University

OTHER

Sponsor Role lead

Responsible Party

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Joakim Johansson

Dr Joakim Johansson

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Östersund Hospital

Östersund, Alberta, Sweden

Site Status

Countries

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Sweden

Other Identifiers

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TCI hypotension TIVA

Identifier Type: -

Identifier Source: org_study_id