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Hemodynamic Stability During Induction of Anaesthesia

U

Umeå University

Status

Completed

Conditions

Fluid Therapy
Anesthesia; Adverse Effect
Hemodynamic Instability

Treatments

Other: gelofusine

Study type

Interventional

Funder types

Other

Identifiers

NCT03394833
2016/361-31

Details and patient eligibility

About

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 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.

Enrollment

80 patients

Sex

All

Ages

18+ years old

Volunteers

No 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.

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

80 participants in 2 patient groups

Preoperative fluids
Experimental group
Description:
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).
Treatment:
Other: gelofusine
No preoperative fluids
No Intervention group
Description:
40 individuals anesthetized by TCI (n = 20) or RSI (n =20) without preoperative fluids.

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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