The effect of crystalloid co-loading on circulatory stability during general anaesthesia induction

• Register: ISRCTN
• Last refreshed on: 29 November 2021
• Main ID: ISRCTN46293288
• Date of registration: 15/03/2017
• Prospective Registration: No
• Primary sponsor: University Medical Centre Maribor
• Public title: The effect of crystalloid co-loading on circulatory stability during general anaesthesia induction
• 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
• Date of first enrolment: 01/01/2017
• Target sample size: 50
• Recruitment status: Completed
• URL: https://www.isrctn.com/ISRCTN46293288
• Study type: Interventional
• Study design: Single-centre prospective randomized controlled trial (Other)
• Phase: Not Applicable

Countries of recruitment

Slovenia

Contacts

• Name: Darjan Kos

Key inclusion & exclusion criteria

Inclusion criteria:
1. Aged 50 years and over
2. ASA II-III
3. Patients scheduled for major abdominal surgery

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


Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Cardiovascular disease and abdominal surgery
Surgery
Cardiovascular disease and abdominal surgery

Intervention(s)

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

Primary Outcome(s)

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(s)

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

Secondary ID(s)

IRP-2015/02-06

Source(s) of Monetary Support

University Medical Centre Maribor

Results

• Results available: Yes
• Date Completed: 31/12/2019