Bispectral index guided induction of general anaesthesia in patients scheduled for major abdominal surgery: propofol versus etomidate

ISRCTN ISRCTN68690518
DOI https://doi.org/10.1186/ISRCTN68690518
Secondary identifying numbers N/A
Submission date
22/01/2011
Registration date
01/03/2011
Last edited
07/09/2011
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Surgery
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Mrs Andreja Möller Petrun
Scientific

Ljubljanska ulica 5
Maribor
2000
Slovenia

Email andreja@moellerpetrun.net

Study information

Study designSingle-centre double blinded crossover randomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleBispectral 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
Study acronymBIS PROPETO
Study objectivesWe 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(s)National Medical Ethics Committee approved on the 28th September 2010 (ref. 117/09/10)
Health condition(s) or problem(s) studiedGeneral anaesthesia in major abdominal surgery
InterventionThe 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 typeDrug
Pharmaceutical study type(s)
PhaseNot Applicable
Drug / device / biological / vaccine name(s)Propofol, etomidate
Primary outcome measureMeasured 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 measures1. Dose of each induction agent
2. Time from start of anaesthesia induction to laryngoscopy and intubation
3. Dose of each needed rescue drug
Overall study start date01/11/2010
Completion date01/05/2011

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants40
Key inclusion criteria1. 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.
Key exclusion criteria1. 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
Date of first enrolment01/11/2010
Date of final enrolment01/05/2011

Locations

Countries of recruitment

  • Slovenia

Study participating centre

Ljubljanska ulica 5
Maribor
2000
Slovenia

Sponsor information

University Medical Centre Maribor (Slovenia)
Hospital/treatment centre

Department of Anaesthesiology
Intensive Care Therapy and Pain Management
Ljubljanska ulica 5
Maribor
2000
Slovenia

Email mirt.kamenik@ukc-mb.si
ROR logo "ROR" https://ror.org/02rjj7s91

Funders

Funder type

Hospital/treatment centre

University Medical Centre Maribor (Slovenia) - Department of Anaesthesiology, Intensive Care Therapy and Pain Management

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan