Contact information
Type
Scientific
Primary contact
Mrs Andreja Möller Petrun
ORCID ID
Contact details
Ljubljanska ulica 5
Maribor
2000
Slovenia
andreja@moellerpetrun.net
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Bispectral index guided induction of general anaesthesia in patients scheduled for major abdominal surgery: single-centre double blinded crossover randomised controlled trial of propofol versus etomidate
Acronym
BIS PROPETO
Study hypothesis
We will compare the induction of general anaesthesia with etomidate and propofol both titrated to the same bispectral index value:
1. Can we reach a decrease of the needed dose and an alleviation of the negative haemodynamic effects of the induction agent by titrating it to the needed anaesthesia depth?
2. Which induction agent has more negative haemodynamic effects after intubation in terms of hypotension and bradycardia?
3. Which induction agent is accompanied by more tachycardia and hypertension during laryngoscopy and intubation?
4. Is the time of titration of both induction agents to the appropriate anaesthesia depth comparable?
5. Are the haemodynamic effects of both induction agents comparable?
Ethics approval
National Medical Ethics Committee approved on the 28th September 2010 (ref. 117/09/10)
Study design
Single-centre double blinded crossover randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
General anaesthesia in major abdominal surgery
Intervention
The study will compare the haemodynamic effects of two intravenous induction agents which will be titrated to the appropriate anaesthesia depth monitored with bispectral index monitor.
Two groups of patients are scheduled for major abdominal surgery. The only difference between the groups is the random chosen induction agent for general anaesthesia: propofol or etomidate. With a constant rate the induction agent is titrated with a perfusor to a bispectral index of 60, then the infusion is stopped. After 1 minute the patient is intubated and ventilated with a mixture of oxygen and air (40:60) and 1% sevoflurane.
Bispectral index, heart rate (HR), oxygen saturation, invasive measured mean arterial pressure (MAP) and cardiac output are measured. The values are written down every minute from 2 minutes before the beginning of the anaesthesia induction until 10 minutes after intubation. A BIS monitor is used to monitor the bispectral index. The haemodynamic parameters are measured with a LiDCOrapid monitor. The time from the beginning of the infusion to the bispectral index 60 and from the beginning of the infusion to the disappearance of the eyelash reflex is also measured. At the end of the follow-up the induction agent is identified and a note of the dose of the induction agent is made.
There is a rescue protocol for excessive hypotension (mean arterial pressure [MAP] less than 55 mmHg), hypertension (MAP greater than 100 mmHg), bradycardia (heart rate [HR] less than 40/min), tachycardia (HR greater than 90/min) or arrhythmia. The rescue drugs are:
1. Ephedrine 5 mg, phenylephrine 50 µg or atropine 0.3 mg in case of hypotension or bradycardia
2. Fentanyl 0.01 mg/kg, nitroglycerine 10 - 100 µg/min or esmolol 25 - 200 µg/kg/min in case of hypertension or tachycardia or arrhythmia
Intervention type
Drug
Phase
Not Applicable
Drug names
Propofol, etomidate
Primary outcome measure
Measured from the start of induction till 10 minutes after intubation:
1. Middle arterial pressure
2. Pulse
3. Cardiac output
4. Bispectral index
5. Oxygen saturation of haemoglobin
Secondary outcome measures
1. Dose of each induction agent
2. Time from start of anaesthesia induction to laryngoscopy and intubation
3. Dose of each needed rescue drug
Overall trial start date
01/11/2010
Overall trial end date
01/05/2011
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Aged over 40 years, either sex
2. American Society of Anasthesiologists (ASA) grade III
3. Scheduled for major abdominal surgery (large bowel resection, stomach resection, liver resection, Whipple resection)
All patients will get an epidural catheter in the lower half of the thoracic spine.
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
40
Participant exclusion criteria
1. Alcohol-abuse
2. Drug abuse
3. Chronic use of benzodiazepines, opioides or other psychotrophic substances
4. Body mass index greater than 30
5. Anticipated difficult intubation (Mallampati 3 and 4)
6. Kidney disease (serum kreatinin greater than 120 mmol/l)
7. Manifest liver disease
8. Alzheimer disease
9. Epilepsy
10. Left ventricle ejection fraction less than 30%
11. Haemodynamic important heart valve disease
12. Pacemaker
Recruitment start date
01/11/2010
Recruitment end date
01/05/2011
Locations
Countries of recruitment
Slovenia
Trial participating centre
Ljubljanska ulica 5
Maribor
2000
Slovenia
Sponsor information
Organisation
University Medical Centre Maribor (Slovenia)
Sponsor details
Department of Anaesthesiology
Intensive Care Therapy and Pain Management
Ljubljanska ulica 5
Maribor
2000
Slovenia
mirt.kamenik@ukc-mb.si
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Hospital/treatment centre
Funder name
University Medical Centre Maribor (Slovenia) - Department of Anaesthesiology, Intensive Care Therapy and Pain Management
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list