Hemodynamic Stability During Induction of Anaesthesia

Sponsor

Umeå University (Other)

Overall Status

Completed

CT.gov ID

NCT03394833

Collaborator

(none)

Enrollment

Location

Arms

17.3

Actual Duration (Months)

4.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hemodynamic Instability Fluid Therapy Anesthesia; Adverse Effect	Other: gelofusine	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

80 participants

Allocation:

Randomized

Intervention Model:

Single Group Assignment

Intervention Model Description:

Non-blinded randomization. Standardized method comparison.Non-blinded randomization. Standardized method comparison.

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

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

Actual Study Start Date :

Nov 20, 2017

Actual Primary Completion Date :

Dec 15, 2018

Actual Study Completion Date :

Apr 30, 2019

Arms and Interventions

Arm	Intervention/Treatment
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).	Other: gelofusine Preoperative colloid fluid bolus 6ml/kg ideal body weight Other Names: colloid fluid
No Intervention: No preoperative fluids 40 individuals anesthetized by TCI (n = 20) or RSI (n =20) without preoperative fluids.

Arm

Intervention/Treatment

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).

Other: gelofusine

Preoperative colloid fluid bolus 6ml/kg ideal body weight

Other Names:

colloid fluid

No Intervention: No preoperative fluids

40 individuals anesthetized by TCI (n = 20) or RSI (n =20) without preoperative fluids.

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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.