Condition category
Surgery
Date applied
22/01/2011
Date assigned
01/03/2011
Last edited
07/09/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 measures

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

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes