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Completed

NCT Number: NCT02834000

Haemodynamic Response to General Anaesthesia in Healthy Orthopaedic Patients

Continuous cardiovascular monitoring as part of management of high-risk surgical patients is widely practiced, however its role in low-risk surgical patients is unclear. Detailed monitoring of cardiovascular parameters from pre-induction stage allows clinicians to individualise anaesthetic management in the perioperative period. The investigators' aim was to investigate haemodynamic and Bispectral Index (BIS) changes in healthy patients undergoing surgery following induction of anaesthesia with propofol using a continuous non-invasive blood pressure device (LiDCOrapid™).

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Key information

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

Recruitment Orthopaedic surgical teams, anaesthetists and theatre staff were made aware of the study that was being conducted at the investigators' institution. Prospective subjects that met the inclusion criteria were identified from the hospital operating theatre's database two weeks prior to surgery. A letter, which contained the study's objectives and methods, was sent out to all patients. Subsequently, a telephone call was made to patients one week before surgery to clarify any queries they had. Consent was obtained on the morning of surgery. All study participants provided written informed consent.

Peri-operative monitoring LiDCO™ CNAP and BIS monitoring were attached prior to induction of anaesthesia in the anaesthetic room of the operating theatre. A standardised anaesthetic technique was used for every participant, consisting of propofol induction, sevoflurane maintenance to a target BIS (40-60) and opioid analgesia with fentanyl. Participants underwent positive pressure ventilation to a tidal volume of 8ml/kg.

Measurements of the following variables were taken continuously from pre-induction to time of extubation: heart rate, mean arterial blood pressure, stroke volume, cardiac output, systemic vascular resistance and BIS. Data recorded up to 3 minutes following propofol injection was analysed to capture the post-induction period. Further measurements were taken in recovery room. The total quantity and type of fluids, drugs administered, time of tourniquet application and removal (if performed), and the duration of the operation were recorded.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients included in the study were those aged 18-45 years undergoing elective lower limb arthroscopic procedures with an American Society of Anesthesiologists (ASA) Grade of I-II.

Exclusion criteria

  • Patients unable or unwilling to provide valid informed consent,
  • Patients undergoing regional anaesthesia,
  • Patients that have contraindications to the LiDCO rapid™ CNAP monitoring (cardiac arrhythmias, aortic regurgitation and digital ischaemia) and BIS monitoring (hypersensitivity to adhesive use) and refusal of surgical, anaesthetic or operating theatre team.

Treatment and study plan

LiDCO rapid™ CNAP monitoring

Device

LiDCO rapid™ CNAP monitoring allows through analysis of the arterial blood pressure trace to acquire information about CO, HR variability, SVR, SV and BIS during general anaesthesia.

Other names: http://www.lidco-ir.co.uk

Primary outcomes

  1. Cardiac output (mls blood/ minute)

    Time frame: From induction up to 3 minutes

Secondary outcomes

  1. Depth of anaesthesia using Bispectral Index (BIS)

    Time frame: From induction up to 3 minutes

Sponsors and collaborators

Lead sponsor

Chelsea and Westminster NHS Foundation Trust

Other

Registry information

Official study title

Haemodynamic Response to General Anaesthesia Induction in Elective Orthopaedic Surgery Patients Using Non-invasive Cardiovascular Monitoring

Acronym: HRespToAS

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Jul 15, 2016
Registry last updated
Jul 15, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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