Haemodynamic stability during anaesthesia induction with propofol ? the impact of phenylephrine

The impact of phenylephrine infusion on haemodynamic stability during bispectral index (BIS) guided anaesthesia induction with propofol ? a double-blind randomised controlled trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN81365561

Enrollment

Registered

2014-07-11

Start date

2013-11-01

Completion date

Unknown

Last updated

2020-06-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiovascular disease and abdominal cancer surgery Surgery

Interventions

We will study the haemodynamic effects of intravenous anaesthesia induction with propofol titrated to the appropriate anaesthesia depth monitored with spectral index monitor. During induction the pati

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: ASA II-III patients scheduled for major abdominal surgery (large bowel resection, stomach resection, liver resection, Whipple resection) and major urologic surgery (bladder resection, prostatic cancer).

Exclusion criteria

Exclusion criteria: 1. Alcohol-abuse 2. Drug abuse 3. Chronic use of benzodiazepines, opioids or other psychotropic substances 4. Body mass index > 30 5. Anticipated difficult intubation (Mallampati 3 and 4) 6. Kidney disease (serum creatinine > 120 mmol/l) 7. Manifest liver disease 8. Alzheimer disease 9. Epilepsy

Design outcomes

Primary

Measure	Time frame
1. Mean arterial pressure 2. Cardiac output 3. Systemic vascular resistance All outcomes will be measured by the LIDCCORapid monitor for measuring cardiac output. The new generation of LIDCCORapid monitor enables also the measurement of the depth of anaesthesia with the BIS monitor. The measurements will be done at baseline and for 20 minutes during the induction of anaesthesia. The LIDCCORapid monitor enables automatic online collection of the data which will be averaged over one minute intervals for the period of induction. The averaged data for both groups of the results will be presented for baseline values, the values immediately before laryngoscopy and intubation, 2 minutes after intubation and then in 3 minute intervals till the end of measurements.	—

Measure

Time frame

1. Mean arterial pressure 2. Cardiac output 3. Systemic vascular resistance All outcomes will be measured by the LIDCCORapid monitor for measuring cardiac output. The new generation of LIDCCORapid monitor enables also the measurement of the depth of anaesthesia with the BIS monitor. The measurements will be done at baseline and for 20 minutes during the induction of anaesthesia. The LIDCCORapid monitor enables automatic online collection of the data which will be averaged over one minute intervals for the period of induction. The averaged data for both groups of the results will be presented for baseline values, the values immediately before laryngoscopy and intubation, 2 minutes after intubation and then in 3 minute intervals till the end of measurements.

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Secondary

Measure	Time frame
1. Heart rate 2. Stroke volume 3. Bispectral index 4. Oxygen saturation 5. Dose of propofol 6. Time from start of anaesthesia induction to laryngoscopy and intubation 7. Dose of rescue drugs needed The other secondary outcome measures: the dose of propofol during induction of anaesthesia, the time to laryngoscopy and intubation, the frequency of rescue medication used and the dose of rescue medication given is registered during the study for each study subject and the data are collected on our protocol sheet.	—

Measure

Time frame

1. Heart rate 2. Stroke volume 3. Bispectral index 4. Oxygen saturation 5. Dose of propofol 6. Time from start of anaesthesia induction to laryngoscopy and intubation 7. Dose of rescue drugs needed The other secondary outcome measures: the dose of propofol during induction of anaesthesia, the time to laryngoscopy and intubation, the frequency of rescue medication used and the dose of rescue medication given is registered during the study for each study subject and the data are collected on our protocol sheet.

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Countries

Slovenia

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026