Hemodynamic Stability During Induction of Anaesthesia

Overview

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.

Full Title of Study: “Hemodynamic Stability During an Induction of Anaesthesia: A Randomized, Non-blinded Study”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Other
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 15, 2018

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.

Interventions

  • Other: gelofusine
    • Preoperative colloid fluid bolus 6ml/kg ideal body weight

Arms, Groups and Cohorts

  • Experimental: Preoperative fluids
    • 40 individuals receiving preoperative colloid fluid bolus at 6 ml/kg LBW, (Gelofusine™, Fresenius Kabi AB, Sweden) before anesthesia induction by TCI (n = 20) or RSI (n =20).
  • No Intervention: No preoperative fluids
    • 40 individuals anesthetized by TCI (n = 20) or RSI (n =20) without preoperative fluids.

Clinical Trial Outcome Measures

Primary Measures

  • 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
  • Effect of preoperative fluid bolus
    • Time Frame: 20 minutes post anesthesia induction
    • Does preoperative fluid bolus decrease incidence of blood pressure drops

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Umeå University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Tomi Myrberg, Principal Investigator – Umeå University
  • Overall Official(s)
    • Tomi P Myrberg, MD PhD, Principal Investigator, Umeå University, Norrbotten county concil

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