Haemodynamic Response to General Anaesthesia in Healthy Orthopaedic Patients

Hypotension Clinical Trial

— HRespToAS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02834000
• Other study ID #: 14/WM/0179
• Status: Completed
• Phase: N/A
• First received: May 10, 2016
• Last updated: July 12, 2016
• Start date: June 2014
• Est. completion date: November 2014

Study information

• Verified date: July 2016
• Source: Chelsea and Westminster NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial 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™).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: November 2014
• Est. primary completion date: November 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 45 Years

Eligibility

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.

Study Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Hypotension

Intervention

Device:
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Chelsea and Westminster NHS Foundation Trust

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cardiac output (mls blood/ minute)		From induction up to 3 minutes	Yes
Secondary	Depth of anaesthesia using Bispectral Index (BIS)		From induction up to 3 minutes	No