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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03394833
Other study ID # 2016/361-31
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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, Gelofusineā„¢, 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.

Study Design


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
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