Hemodynamic Stability During Induction of Anaesthesia

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03394833

Enrollment

Registered

2018-01-09

Start date

2017-11-20

Completion date

2019-04-30

Last updated

2019-09-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anesthesia; Adverse Effect, Fluid Therapy, Hemodynamic Instability

Keywords

preoperative, fluid therapy, hemodynamics, anesthesia induction, rapid sequence induction, TCI

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.

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

OTHERgelofusine

Preoperative colloid fluid bolus 6ml/kg ideal body weight

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

OTHER

Masking

NONE

Intervention model description

Non-blinded randomization. Standardized method comparison.

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Incidence of blood pressure drops	20 minutes post anesthesia induction	blood pressure drop below mean arterial pressure at 65 mmHg during anesthesia induction
Effect of preoperative fluid bolus	20 minutes post anesthesia induction	Does preoperative fluid bolus decrease incidence of blood pressure drops

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 21, 2026