Haemodynamic Response to General Anaesthesia in Healthy Orthopaedic Patients

NCT ID: NCT02834000

Last Updated: 2016-07-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-06-30
• Study Completion Date: 2014-11-30

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.

Conditions

Hypotension

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Standard Care

We will compare the standard monitored group of patients with the LiDCO rapid™ monitored group. The control group will compose of patients supervised in a standard way.

Group Type: NO_INTERVENTION

No interventions assigned to this group

LiDCO rapid™ CNAP monitoring

Young, healthy adult patients (ASA I and II) undergoing elective orthopaedic surgery under general anaesthesia will be included in to this study. We will compare the standard monitored group of patients with the LiDCO rapid™ monitored group. We will use in the LiDCO rapid™ CNAP monitoring group, the continuous real time haemodynamic monitoring through non-invasive arterial pressure waveform. The monitor LiDCO rapid™ CNAP permits, through analysis the arterial blood pressure trace, to acquire information about CO, SVR, HR variability, SV and BIS.

Group Type: EXPERIMENTAL

LiDCO rapid™ CNAP monitoring

Intervention Type: 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.

Interventions

LiDCO rapid™ CNAP monitoring

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.

Intervention Type: DEVICE

Other Intervention Names

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

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Chelsea and Westminster NHS Foundation Trust

OTHER

Sponsor Role: lead

Responsible Party

Marcela P. Vizcaychipi

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

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

14/WM/0179

Identifier Type: -

Identifier Source: org_study_id