Hemodynamic Stability During Induction of Anaesthesia

NCT03394833 | Completed

• 1 other identifier: 2016/361-31
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Hemodynamic Instability; Fluid Therapy; Anesthesia; Adverse Effect

Keywords

preoperative; fluid therapy; hemodynamics; anesthesia induction; rapid sequence induction; TCI

Outcome Measures

Primary Outcomes (2)

• Incidence of blood pressure drops

  blood pressure drop below mean arterial pressure at 65 mmHg during anesthesia induction

  20 minutes post anesthesia induction

• Effect of preoperative fluid bolus

  Does preoperative fluid bolus decrease incidence of blood pressure drops

  20 minutes post anesthesia induction

Study Arms (2)

Preoperative fluids

EXPERIMENTAL

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

No preoperative fluids

NO INTERVENTION

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

Interventions

gelofusine OTHER

Preoperative colloid fluid bolus 6ml/kg ideal body weight

Also known as: colloid fluid

Preoperative fluids

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• individuals over 18 years, body mass index ≤ 35 kg/m2, electively scheduled for breast cancer surgery, endocrinologic surgery (thyroid, parathyroid) and general abdominal surgery.

You may not qualify if:

• instable angina pectoris at the day of surgery, severe bronchial asthma or COPD.

Sponsors & Collaborators

• Umeå University: lead

Study Sites (1)

Sunderby hospital

Luleå, 97180, Sweden

Location

Related Publications (1)

• 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.

  PMID: 31240711 DERIVED

MeSH Terms

Interventions

Polygeline

Intervention Hierarchy (Ancestors)

Polymers; Macromolecular Substances; Peptides; Amino Acids, Peptides, and Proteins; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture

Study Officials

• Tomi P Myrberg, MD PhD

  Umeå University, Norrbotten county concil

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Non-blinded randomization. Standardized method comparison.

Study Record Dates

• First Submitted: November 17, 2017
• First Posted: January 9, 2018
• Study Start: November 20, 2017
• Primary Completion: December 15, 2018
• Study Completion: April 30, 2019
• Last Updated: September 26, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)