Hemodynamic Stability During Induction of Anaesthesia

Hemodynamic Instability Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03394833
• Other study ID #: 2016/361-31
• Status: Completed
• Phase: N/A
• Start date: November 20, 2017
• Est. completion date: April 30, 2019

Study information

• Verified date: September 2019
• Source: Umeå University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: April 30, 2019
• Est. primary completion date: December 15, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Anesthesia; Adverse Effect
• Fluid Therapy
• Hemodynamic Instability

Intervention

Other:
• gelofusine
Preoperative colloid fluid bolus 6ml/kg ideal body weight

Locations

Country	Name	City	State
Sweden	Sunderby hospital	Luleå

Sponsors (1)

Lead Sponsor	Collaborator
Umeå University

Country where clinical trial is conducted

Sweden, 

Outcome

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