The effect of crystalloid co-loading on circulatory stability during general anaesthesia induction
| ISRCTN | ISRCTN46293288 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN46293288 |
| Secondary identifying numbers | IRP-2015/02-06 |
- Submission date
- 26/10/2016
- Registration date
- 15/03/2017
- Last edited
- 25/11/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
Plain English summary of protocol
Background and study aims
Most patients undergoing major abdominal surgery are adults or elderly patients with at least one other medical condition. Propofol is the most common induction agent. Although effective, propofol can lead to undesirable side effects such as a decrease in blood pressure and cardiac output (the amount of blood the heart pumps in 1 minute). Vasopressors are a group of drugs that are often given to patients to raise blood pressure. In a previous study, it was shown that this is an effective way of preventing a decrease in blood pressure during induction, but it does not have a significant effect on cardiac output. The aim of this study is to investigate the effects on the heart and circulation of giving an additional dose of crystalloids (co-loading) while simultaneously giving vasopressors compared to a more restrictive fluid regimen.
Who can participate?
Adult/elderly patients undergoing major high-risk abdominal surgery.
What does the study involve?
Patients are randomly allocated into two groups. Both groups are given the vasopressor phenylephrine continually while being put under general anaesthesia with propofol. Those in the control group are given crystalloids (Ringer's solution) in a restrictive regimen during the induction of anaesthesia. Those in the test group are given an additional dose of crystalloids during the induction of anaesthesia. The haemodynamic parameters (e.g. cardiac output and blood pressure) in both groups are measured and compared during and after the induction before surgery begins.
What are the possible benefits and risks of participating?
Patients in both groups benefit from being closely monitored with an advanced circulation monitoring system. There are no notable risks involved with participating.
Where is the study run from?
University Medical Centre Maribor (Slovenia)
When is the study starting and how long is it expected to run for?
November 2016 to December 2019
Who is funding the study?
University Medical Centre Maribor (Slovenia)
Who is the main contact?
Dr Darjan Kos
Contact information
Scientific
University Medical Centre Maribor
Ljubljanska ulica 5
Maribor
2000
Slovenia
Study information
| Study design | Single-centre prospective randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Other |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | ASA II-III patients undergoing large abdominal surgery, the impact of crystalloid co-loading (two different rates of infusion) with concomitant phenylephrine infusion on haemodynamic stability during bispectral (BIS) guided anaesthesia induction with propofol, a randomised controlled study |
| Study acronym | BISPROPRINGPHEN |
| Study objectives | Current study hypothesis as of 24/11/2021: 1. There will be higher stroke volume, cardiac output and mean arterial pressure in the intervention group compared to the control group 2. There will be no difference in heart rate and systemic vascular resistance among groups 3. Stroke volume variation will be lower in the intervention group compared to the control group Previous study hypothesis: The aim of this study is to: 1. Compare the bispectral index guided induction of general anaesthesia with propofol combined with phenylephrine and restrictive regime of Ringer solution infusion and propofol combined with phenylephrine and large bolus of Ringer solution infusion 2. Investigate the impact of a larger bolus of Ringer solution on haemodynamic parameters during and after induction |
| Ethics approval(s) | National Medical Ethics Committee, 13/07/2016, ref: 67/05/16 |
| Health condition(s) or problem(s) studied | Cardiovascular disease and abdominal surgery |
| Intervention | In the operating theatre, participants are randomised to one of two groups using envelope randomisation. Group 1: Participants receive fentanyl in a bolus of 3 mcg/kg after 1 minute of basal monitoring. Then there are additional 2 minutes of monitoring as we have to wait for fentanyl to become effective. 2 minutes after fentanyl (that means 3 minutes after we started monitoring) we begin with the infusion of propofol (0.5 mg/kg/min), phenylephrine (0.5 mcg/kg/min) and Ringer solution (restrictive regime meaning 1 ml/kg in following 15 minutes). The propofol is titrated to reach BIS value 60 (appropriate depth of anaesthesia) in each individual patient. After reaching BIS value 60, the infusion of propofol is stopped and the cumulative quantity measured for each individual patient. While receiving propofol infusion we assess the patient's plapebral reflex and when lost the patients are given relaxans rocuronium in a bolus of 1 mg/kg. One minute after a bolus of rocuronium the patients are intubated (the time from the beginning of monitoring to intubation is recorded for each patient). Phenylephrine and Ringer solution infusion is continued at a constant rate (as already mentioned) to the end of monitoring. Group 2: Participants receive the same regime of drugs except the Ringer solution infusion is different as they are given a large bolus of 10 ml/kg in 15 minutes following the start of induction. Protocol for both groups of participants includes rescue measurements also in case of haemodynamic instability: 1. Bradycardia (<40 beats per minute for more than 1 minute): bolus of atropine 0,3 mg, repeated until effective 2. Tachycardia (>100 beats per minute for more than 1 minute): bolus of fentanyl 3 mcg/kg max 3 times, then a bolus of esmolol 1mg/kg 3. Hypotension (MAP <55 mmHg for more than 1 minute): additional phenylephrine boluses of 50 mcg 4. Hypertension (MAP >100 mmHg for more than 1minute): the infusion of phenylephrine will be stopped, then a bolus of fentanyl 3 mcg/kg max 3 times Participants have their cardiac output, stroke volume and mean arterial pressure measured using a LiDCOrapid monitor at baseline and for 15 minutes during the induction of anaesthesia. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | Current primary outcome measures as of 24/11/2021: 1. Cardiac output is measured using a LiDCOrapid monitor at baseline and for 15 minutes during the induction of anaesthesia 2. Mean arterial pressure is measured using a LiDCOrapid monitor at baseline and for 15 minutes during the induction of anaesthesia Previous primary outcome measures: 1. Cardiac output is measured using a LiDCOrapid monitor at baseline and for 15 minutes during the induction of anaesthesia 2. Stroke volume is measured using a LiDCOrapid monitor at baseline and for 15 minutes during the induction of anaesthesia 3. Mean arterial pressure is measured using a LiDCOrapid monitor at baseline and for 15 minutes during the induction of anaesthesia |
| Secondary outcome measures | Current secondary outcome measures as of 24/11/2021: 1. Heart rate is measured using a LiDCOrapid monitor at baseline and for 15 minutes during the induction of anaesthesia 2. Stroke volume is measured using a LiDCOrapid monitor at baseline and for 15 minutes during the induction of anaesthesia 3. Systemic vascular resistance is measured using a LiDCOrapid monitor at baseline and for 15 minutes during the induction of anaesthesia 4. Stroke volume variation is measured using a LiDCOrapid monitor at baseline and for 15 minutes during the induction of anaesthesia. 5. Dose of propofol is measured at the end of induction (the cumulative dose is given on the perfusor screen) 6. Time from the start of anaesthesia induction to laryngoscopy and intubation is measured for each patient using the timer on the screen of the anaesthesia machine 7. Potential rescue management is recorded for each patient at the end of induction 8. Doses of drugs needed is calculated at the end of induction for each patient Previous secondary outcome measures: 1. Heart rate is measured using a LiDCOrapid monitor at baseline and for 15 minutes during the induction of anaesthesia 2. Systemic vascular resistance is measured using a LiDCOrapid monitor at baseline and for 15 minutes during the induction of anaesthesia 3. Bispectral index is measured using a LiDCOrapid monitor at baseline and for 15 minutes during the induction of anaesthesia 4. Dose of propofol is measured at the end of induction (the cumulative dose is given on the perfusor screen) 5. Time from start of anaesthesia induction to laryngoscopy and intubation is measured for each patient using the timer on the screen of the anaesthesia machine 6. Potential rescue management is recorded for each patient at the end of induction 7. Doses of drugs needed is calculated at the end of induction for each patient |
| Overall study start date | 01/05/2016 |
| Completion date | 31/12/2019 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Mixed |
| Sex | Both |
| Target number of participants | 50 |
| Total final enrolment | 60 |
| Key inclusion criteria | 1. Aged 50 years and over 2. ASA II-III 3. Patients scheduled for major abdominal surgery |
| Key exclusion criteria | 1. Heart failure (known ejection fraction less than 30%) 2. Manifest liver disease 3. Kidney disease (serum creatinine more than 120 mmol/L) 4. BMI more than 30 5. Anticipated difficult intubation (Mallampati score 3 and 4) 6. Drug abuse (including alcohol) 7. Chronic use of benzodiazepines, opioids or other psychotropic substances |
| Date of first enrolment | 01/01/2017 |
| Date of final enrolment | 31/07/2019 |
Locations
Countries of recruitment
- Slovenia
Study participating centre
Maribor
2000
Slovenia
Sponsor information
Hospital/treatment centre
Medical research department
Ljubljanska ulica 5
Maribor
2000
Slovenia
"ROR" |
https://ror.org/02rjj7s91 |
|---|
Funders
Funder type
Hospital/treatment centre
No information available
Results and Publications
| Intention to publish date | 31/12/2021 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Other |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal. |
| IPD sharing plan | The datasets generated and analysed during the current study will be included in the subsequent results publication. |
Editorial Notes
25/11/2021: Total final enrolment added.
24/11/2021: The following changes were made to the trial record:
1. The public title was changed from 'Circulatory stability during anaesthesia induction with propofol - the impact of Ringer solution infusion' to 'The effect of crystalloid co-loading on circulatory stability during general anaesthesia induction'.
2. The scientific title was changed from 'ASA II-III patients undergoing large abdominal surgery, the impact of Ringer solution infusion (two different rates of infusion) with concomitant phenylephrine infusion on haemodynamic stability during bispectral (BIS) guided anaesthesia induction with propofol, a randomised controlled study' to 'ASA II-III patients undergoing large abdominal surgery, the impact of crystalloid co-loading (two different rates of infusion) with concomitant phenylephrine infusion on haemodynamic stability during bispectral (BIS) guided anaesthesia induction with propofol, a randomised controlled study'.
3. The study hypothesis, primary and secondary outcome measures and plain English summary were updated.
4. The overall trial end date was changed from 31/08/2019 to 31/12/2019.
5. The intention to publish date was changed from 31/08/2020 to 31/12/2021.
20/06/2019: The following changes were made to the trial record:
1. The recruitment end date was changed from 31/10/2017 to 31/07/2019.
2. The overall trial end date was changed from 30/11/2017 to 31/08/2019.
3. The intention to publish date was changed from 30/11/2018 to 31/08/2020.
