Hemodynamic Stability During Induction of Anaesthesia

Not Applicable

Completed

• Conditions: Anesthesia; Adverse Effect; Hemodynamic Instability; Fluid Therapy
• Interventions: Other: gelofusine

• Registration Number: NCT03394833
• Lead Sponsor: Umeå University

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.

Study Timeline

• Study First Submitted: 2017-11-17
• Study Start: 2017-11-20
• Study First Submitted QC: 2018-01-08
• Study First Posted: 2018-01-09
• Primary Completion: 2018-12-15
• Study Completion: 2019-04-30
• Status Verified: 2019-09
• Last Update Submitted: 2019-09-25
• Last Update Posted: 2019-09-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Preoperative fluids	gelofusine	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).

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Sunderby hospital; 🇸🇪 Luleå, Sweden