Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02733406
Other study ID # TCI hypotension TIVA
Secondary ID
Status Completed
Phase N/A
First received March 21, 2016
Last updated October 25, 2017
Start date April 2016
Est. completion date August 2017

Study information

Verified date October 2017
Source Umeå University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 76
Est. completion date August 2017
Est. primary completion date August 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Target Controlled Infusion

Velocity Controlled Infusion


Locations

Country Name City State
Sweden Östersund Hospital Östersund Alberta

Sponsors (1)

Lead Sponsor Collaborator
Umeå University

Country where clinical trial is conducted

Sweden, 

Outcome

Type Measure Description Time frame Safety issue
Primary Hypotension Relative maximal decrease of blood pressure (in mmHg) by anaesthesia induction (%) 20 minutes
Secondary Pharmacological measures to increase blood pressure Number of doses of drug to increase blood pressure 20 minutes
Secondary Drug consumption Amount (milligram) of Propofol delivered and amount (mikrogram) of Remifentanil delivered. From the start of anaesthesia induction to the time of airway control (Laryngeal airway working in place of tracheal tube working in place).
Secondary 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) From end of anaesthesia to 2 hours or when leaving the PostAnaesthesia Care Unit
See also
  Status Clinical Trial Phase
Completed NCT03255187 - Effect of Dietary Supplemental Fish Oil in Alleviating Health Hazards Associated With Air Pollution N/A
Completed NCT05997303 - Continuous Norepinephrine Administration and Blood Pressure Stability During Anesthetic Induction N/A
Recruiting NCT04575194 - Study of the Cardiometabolic Effects of Obesity Pharmacotherapy Phase 4
Completed NCT03918486 - Caretaker vs. Routine Blood Pressure Sphygmomanometer
Completed NCT03410342 - The Effects of Types of Fruits and Vegetables on Vascular Function N/A
Active, not recruiting NCT05062161 - Sleep Duration and Blood Pressure During Sleep N/A
Not yet recruiting NCT04087070 - Blood Pressure Estimation Using Noninvasive Biosignals During Pediatric Anesthesia
Completed NCT03294928 - Arterial Waveform Analysis Applying Different Positive End-Expiratory Pressure (PEEP) Levels in Healthy Volunteers N/A
Completed NCT03859934 - Metabolic Effects of Melatonin Treatment Phase 1
Completed NCT03997461 - Comparison of Arterial Tonometry Sensor With Standard Oscillometric Blood Pressure Monitoring Device N/A
Completed NCT03290716 - Diet, ExerCIse and carDiovascular hEalth (DECIDE) - Salt Reduction Strategies for the Elderly in Nursing Homes in China N/A
Recruiting NCT06460233 - Blood Pressure Changes After Bariatric Surgery
Recruiting NCT05196048 - Blood Pressure Sensor of Watch-type Device With ECG Technology
Terminated NCT03325933 - Resistance Training and Cardiometabolic Health N/A
Not yet recruiting NCT06405880 - Pharmacist Case Finding and Intervention for Vascular Prevention Trial N/A
Completed NCT02924454 - Effects of Lipid Emulsion on the Pharmacokinetic and Pharmacodynamic Properties of Metoprolol. Phase 4
Completed NCT02451059 - Reducing Socioeconomic Disparities in Health at Pediatric Visits N/A
Active, not recruiting NCT02670967 - Effects of Soluble Fiber on Blood Pressure: A Meta-analysis of Randomly-controlled Trials N/A
Completed NCT02239744 - Intervention Study on the Health Impact of Air Filters in Chinese Adults N/A
Completed NCT02271633 - Nitrate Supplementation; Source Phase 4