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Clinical Trials/NCT02834000
NCT02834000
Completed
Not Applicable

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

Chelsea and Westminster NHS Foundation Trust0 sites40 target enrollmentJune 2014
ConditionsHypotension

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Hypotension
Sponsor
Chelsea and Westminster NHS Foundation Trust
Enrollment
40
Primary Endpoint
Cardiac output (mls blood/ minute)
Status
Completed
Last Updated
9 years ago

Overview

Brief Summary

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™).

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
June 2014
End Date
November 2014
Last Updated
9 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Chelsea and Westminster NHS Foundation Trust
Responsible Party
Principal Investigator
Principal Investigator

Marcela P. Vizcaychipi

Consultant in Anaesthesia and Intensive Care Medicine, Honorary Senior Clinical Lecturer, Divisional Research Lead for Planned Care Surgery and Clinical Support

Chelsea and Westminster NHS Foundation Trust

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Cardiac output (mls blood/ minute)

Time Frame: From induction up to 3 minutes

Secondary Outcomes

  • Depth of anaesthesia using Bispectral Index (BIS)(From induction up to 3 minutes)

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