Skip to main content
OpenTrials
Completed

NCT Number: NCT02733406

Hypotensive Effect of Anaesthesia With TCI

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Blood Pressure Cardiovascular Diseases Hypotension Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Östersund Hospital

Östersund, Alberta, 83183, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Target Controlled Infusion

Other

Velocity Controlled Infusion

Other

Primary outcomes

  1. Hypotension

    Time frame: 20 minutes

    Relative maximal decrease of blood pressure (in mmHg) by anaesthesia induction (%)

Secondary outcomes

  1. Pharmacological measures to increase blood pressure

    Time frame: 20 minutes

    Number of doses of drug to increase blood pressure

  2. Drug consumption

    Time frame: From the start of anaesthesia induction to the time of airway control (Laryngeal airway working in place of tracheal tube working in place).

    Amount (milligram) of Propofol delivered and amount (mikrogram) of Remifentanil delivered.

  3. PONV (Postoperative Nausea and Vomiting)

    Time frame: From end of anaesthesia to 2 hours or when leaving the PostAnaesthesia Care Unit

    Dose and name of any drug given to reduce PONV at any time defined above (in addition to profylaxis with the same aim)

Sponsors and collaborators

Lead sponsor

Umeå University

Other

Registry information

Official study title

The Effect of Target Controlled Infusion as Opposed to Velocity Controlled Infusion on Hypotension at Induction of Total Intravenous Anaesthesia

Acronym: HEAT

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Apr 11, 2016
Registry last updated
Oct 26, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.