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

• Register: ISRCTN
• Last refreshed on: 8 June 2020
• Main ID: ISRCTN81365561
• Date of registration: 11/07/2014
• Prospective Registration: No
• Primary sponsor: Maribor University Clinical Centre (Slovenia)
• Public title: Haemodynamic stability during anaesthesia induction with propofol ? the impact of phenylephrine
• Scientific title: The impact of phenylephrine infusion on haemodynamic stability during bispectral index (BIS) guided anaesthesia induction with propofol ? a double-blind randomised controlled trial
• Date of first enrolment: 01/11/2013
• Target sample size: 50
• Recruitment status: Completed
• URL: http://isrctn.com/ISRCTN81365561
• Study type: Interventional
• Study design: Single-centre double-blinded prospective randomized controlled trial (Other)
• Phase: Not Applicable

Countries of recruitment

Slovenia

Contacts

• Name: Mirt Kamenik

Key inclusion & exclusion 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:
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


Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Cardiovascular disease and abdominal cancer surgery
Surgery

Intervention(s)

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 patients will receive a continuous infusion of either phenylephrine or saline in a double blind randomized fashion. Hypotension (<55 mmHg) will be managed with additional phenylephrine. Hypertension (>100 mmHg) will be managed with the stop of infusion, additional, fentanyl and nitro-
glycerine. Tachycardia (>90/min) will be managed with fentanyl and esmolol. Bradycardia (<40/min) will be managed with atropine.

Primary Outcome(s)

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.

Secondary Outcome(s)

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.

Secondary ID(s)

IRP-2013/02-06

Source(s) of Monetary Support

Maribor University Clinical Centre (Slovenia)

Ethics review

Status:
Approval date:
Contact:

National Medical Ethics Committee;10/10/2013; ref. 229/09/13

Results

• Results available: Yes
• Date Completed: 01/01/2015