NCT02733406

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
76

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 21, 2016

Completed
11 days until next milestone

Study Start

First participant enrolled

April 1, 2016

Completed
10 days until next milestone

First Posted

Study publicly available on registry

April 11, 2016

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2017

Completed
Last Updated

October 26, 2017

Status Verified

October 1, 2017

Enrollment Period

1.3 years

First QC Date

March 21, 2016

Last Update Submit

October 25, 2017

Conditions

Blood PressureHypotension

Outcome Measures

Primary Outcomes (1)

  • Hypotension

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

    20 minutes

Secondary Outcomes (3)

  • Pharmacological measures to increase blood pressure

    20 minutes

  • Drug consumption

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

  • PONV (Postoperative Nausea and Vomiting)

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

Study Arms (2)

Target Controlled Infusion

OTHER

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

Other: Target Controlled Infusion

Velocity Controlled Infusion

OTHER

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

Other: Velocity Controlled Infusion

Interventions

Target Controlled InfusionOTHER
Target Controlled Infusion
Velocity Controlled InfusionOTHER
Velocity Controlled Infusion

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \* All patients scheduled for anaesthesia at Östersunds Hospital
  • ASA class I-II

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Östersund Hospital

Östersund, Alberta, 83183, Sweden

Location

MeSH Terms

Conditions

Hypotension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr Joakim Johansson

Study Record Dates

First Submitted

March 21, 2016

First Posted

April 11, 2016

Study Start

April 1, 2016

Primary Completion

August 1, 2017

Study Completion

August 1, 2017

Last Updated

October 26, 2017

Record last verified: 2017-10

Data Sharing

IPD Sharing
Will not share

Locations

SE(1)