Hemodynamic Stability During Induction of Anaesthesia

NCT ID: NCT03394833

Last Updated: 2019-09-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-11-20

Study Completion Date

2019-04-30

Brief Summary

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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

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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.

Conditions

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Hemodynamic Instability Fluid Therapy Anesthesia; Adverse Effect

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Non-blinded randomization. Standardized method comparison.
Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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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).

Group Type EXPERIMENTAL

gelofusine

Intervention Type OTHER

Preoperative colloid fluid bolus 6ml/kg ideal body weight

No preoperative fluids

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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gelofusine

Preoperative colloid fluid bolus 6ml/kg ideal body weight

Intervention Type OTHER

Other Intervention Names

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colloid fluid

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Umeå University

OTHER

Sponsor Role lead

Responsible Party

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Tomi Myrberg

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Tomi P Myrberg, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Umeå University, Norrbotten county concil

Locations

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Sunderby hospital

Luleå, , Sweden

Site Status

Countries

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Sweden

References

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Myrberg T, Lindelof L, Hultin M. Effect of preoperative fluid therapy on hemodynamic stability during anesthesia induction, a randomized study. Acta Anaesthesiol Scand. 2019 Oct;63(9):1129-1136. doi: 10.1111/aas.13419. Epub 2019 Jun 26.

Reference Type DERIVED
PMID: 31240711 (View on PubMed)

Other Identifiers

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2016/361-31

Identifier Type: -

Identifier Source: org_study_id

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