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Hemodynamic Stability During Induction of Anaesthesia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03394833
Recruitment Status : Recruiting
First Posted : January 9, 2018
Last Update Posted : January 9, 2018
Information provided by (Responsible Party):

Study Description
Brief Summary:
The study aim is to investigate if preoperative volume bolus based on lean body weight could preserve mean arterial pressure during target controlled infusion of anaesthesia (TCI) or rapid sequence induction of anaesthesia (RSI) in non-cardiac, non-morbidly obese surgery.

Condition or disease Intervention/treatment
Hemodynamic Instability Fluid Therapy Anesthesia; Adverse Effect Other: gelofusine

Detailed Description:

40 individuals are enrolled to TCI and RSI groups respectively. The randomization process for preoperative fluid bolus prior to induction of anaesthesia is conducted in respective group at the day of surgery. Preoperative colloid fluid therapy (6 ml/kg LBW, Gelofusine™, Fresenius Kabi Ab, Sweden) is infused rapidly before non-invasive baseline blood pressure (NIBP) measurements in twenty individuals in each group. No other intravenous fluids before induction of anaesthesia.

NIBPs, pulse frequency, peripheral saturation (SpO2) are registered and collected 20 minutes post induction.

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Intervention Model Description: Non-blinded randomization. Standardized method comparison.
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Hemodynamic Stability During an Induction of Anaesthesia: A Randomized, Non-blinded Study
Actual Study Start Date : February 7, 2017
Estimated Primary Completion Date : March 15, 2018
Estimated Study Completion Date : May 15, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anesthesia
U.S. FDA Resources

Arms and Interventions

Intervention Details:
    Other: gelofusine
    Preoperative colloid fluid bolus 6ml/kg ideal body weight
    Other Name: colloid fluid

Outcome Measures

Primary Outcome Measures :
  1. Incidence of blood pressure drops [ Time Frame: 20 minutes post anesthesia induction ]
    blood pressure drop below mean arterial pressure at 65 mmHg during anesthesia induction

  2. Effect of preoperative fluid bolus [ Time Frame: 20 minutes post anesthesia induction ]
    Does preoperative fluid bolus decrease incidence of blood pressure drops

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 80 individuals over 18 years, body mass index ≤ 35 kg/m2, electively scheduled for breast cancer surgery, endocrinologic surgery (thyroid, parathyroid) and general abdominal surgery.

Exclusion Criteria:

  • instable angina pectoris at the day of surgery, severe bronchial asthma or COPD.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03394833

Contact: Tomi P Myrberg, MD PhD +46920 282000 tomi.myrberg@umu.se

Sunderby hospital Recruiting
Luleå, Sweden, 97180
Contact: Tomi P Myrberg, MD PhD    +46 920 282339    tomi.myrberg@nll.se   
Sub-Investigator: Magnus Hultin, Associate professor         
Sponsors and Collaborators
Umeå University
Principal Investigator: Tomi P Myrberg, MD PhD Umeå University, Norrbotten county concil
More Information

Responsible Party: Tomi Myrberg, Principal Investigator, Umeå University
ClinicalTrials.gov Identifier: NCT03394833     History of Changes
Other Study ID Numbers: 2016/361-31
First Posted: January 9, 2018    Key Record Dates
Last Update Posted: January 9, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Tomi Myrberg, Umeå University:
fluid therapy
anesthesia induction
rapid sequence induction

Additional relevant MeSH terms:
Central Nervous System Depressants
Physiological Effects of Drugs
Plasma Substitutes
Blood Substitutes