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Completed

NCT Number: NCT03394833

Hemodynamic Stability During Induction of Anaesthesia

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.

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Key information

Conditions

Hemodynamic Instability Anesthesia; Adverse Effect Fluid Therapy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sunderby hospital

Luleå, 97180, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

gelofusine

Other

Preoperative colloid fluid bolus 6ml/kg ideal body weight

Other names: colloid fluid

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

Umeå University

Other

Registry information

Official study title

Hemodynamic Stability During an Induction of Anaesthesia: A Randomized, Non-blinded Study

Important dates

Study start
2017
Primary completion
2018
Study completion
2019
First posted
Jan 9, 2018
Registry last updated
Sep 26, 2019

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.

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