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Hypotensive Effect of Anaesthesia With TCI (HEAT)

Primary Purpose

Blood Pressure, Hypotension

Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Target Controlled Infusion
Velocity Controlled Infusion
Sponsored by
Umeå University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Blood Pressure

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Östersund Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Target Controlled Infusion

Velocity Controlled Infusion

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Pharmacological measures to increase blood pressure
Number of doses of drug to increase blood pressure
Drug consumption
Amount (milligram) of Propofol delivered and amount (mikrogram) of Remifentanil delivered.
PONV (Postoperative Nausea and Vomiting)
Dose and name of any drug given to reduce PONV at any time defined above (in addition to profylaxis with the same aim)

Full Information

First Posted
March 21, 2016
Last Updated
October 25, 2017
Sponsor
Umeå University
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1. Study Identification

Unique Protocol Identification Number
NCT02733406
Brief Title
Hypotensive Effect of Anaesthesia With TCI
Acronym
HEAT
Official Title
The Effect of Target Controlled Infusion as Opposed to Velocity Controlled Infusion on Hypotension at Induction of Total Intravenous Anaesthesia
Study Type
Interventional

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
April 2016 (undefined)
Primary Completion Date
August 2017 (Actual)
Study Completion Date
August 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Umeå University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Blood Pressure, Hypotension

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
76 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Target Controlled Infusion
Arm Type
Other
Arm Description
This group of patients will have their anaesthesia induced with Target Controlled Infusion (TCI)
Arm Title
Velocity Controlled Infusion
Arm Type
Other
Arm Description
This group of patients will have their anaesthesia induced with Velocity Controlled Infusion (VCI)
Intervention Type
Other
Intervention Name(s)
Target Controlled Infusion
Intervention Type
Other
Intervention Name(s)
Velocity Controlled Infusion
Primary Outcome Measure Information:
Title
Hypotension
Description
Relative maximal decrease of blood pressure (in mmHg) by anaesthesia induction (%)
Time Frame
20 minutes
Secondary Outcome Measure Information:
Title
Pharmacological measures to increase blood pressure
Description
Number of doses of drug to increase blood pressure
Time Frame
20 minutes
Title
Drug consumption
Description
Amount (milligram) of Propofol delivered and amount (mikrogram) of Remifentanil delivered.
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).
Title
PONV (Postoperative Nausea and Vomiting)
Description
Dose and name of any drug given to reduce PONV at any time defined above (in addition to profylaxis with the same aim)
Time Frame
From end of anaesthesia to 2 hours or when leaving the PostAnaesthesia Care Unit

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Östersund Hospital
City
Östersund
State/Province
Alberta
ZIP/Postal Code
83183
Country
Sweden

12. IPD Sharing Statement

Plan to Share IPD
No

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Hypotensive Effect of Anaesthesia With TCI

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