Hemodynamic Stability During Induction of Anaesthesia
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|ClinicalTrials.gov Identifier: NCT03394833|
Recruitment Status : Recruiting
First Posted : January 9, 2018
Last Update Posted : June 6, 2018
|Condition or disease||Intervention/treatment||Phase|
|Hemodynamic Instability Fluid Therapy Anesthesia; Adverse Effect||Other: gelofusine||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||80 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Non-blinded randomization. Standardized method comparison.|
|Masking:||None (Open Label)|
|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 :||September 15, 2018|
|Estimated Study Completion Date :||October 15, 2018|
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).
Preoperative colloid fluid bolus 6ml/kg ideal body weight
Other Name: colloid fluid
No Intervention: No preoperative fluids
40 individuals anesthetized by TCI (n = 20) or RSI (n =20) without preoperative fluids.
- 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
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 email@example.com|
|Luleå, Sweden, 97180|
|Contact: Tomi P Myrberg, MD PhD +46 920 282339 firstname.lastname@example.org|
|Principal Investigator:||Tomi P Myrberg, MD PhD||Umeå University, Norrbotten county concil|