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Haemodynamic Effect of Intravenous Paracetamol during and after Cardiac Surgery

Haemodynamic Effect of Intravenous Paracetamol during and after Cardiac Surgery

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12615001099516
Enrollment
50
Registered
2015-10-19
Start date
2013-06-07
Completion date
2014-11-19
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

There are currently no double-blinded, randomised controlled trials that assess the haemodynamic effects of paracetamol in patients undergoing cardiac surgery. The effects of cardiopulmonary bypass (CPB) on paracetamol pharmacokinetic are also poorly understood. This study will add to a growing body of evidence evaluating the safety and efficacy of paracetamol use in patients undergoing cardiac surgery. Hypothesis: Paracetamol (1g IV) has adverse effects on blood pressure in patients undergoing cardiac surgery. No of patients: 50 No of recruiting hospitals: 1 Randomisation: Patients will be randomised in a 1:1 fashion via a computer generated randomisation program to either paracetamol IV formulation (N=25) or control treatment (normal saline 0.9%) (N=25). Blinding: This is a double-blinded clinical trial. Surgical teams, intraoperative and postoperative nursing staff, and patients will be blinded to assignment of treatment.

Interventions

Intravenous paracetamol (Actavis, North Adelaide, SA) Paracetamol is one of the most commonly used medications in the world. The intravenous format is the preferred method of administration in the intraoperative and immediate postoperative periods. In 100mL of solution for infusion, intravenous paracetamol contains the following: Paracetamol = 1g Mannitol = 3.91g Cysteine hydrochloride monohydrate Dibasic dihydrate sodium phosphate Sodium hydroxide Hydrochloric acid Water for injections Th

Intravenous paracetamol (Actavis, North Adelaide, SA) Paracetamol is one of the most commonly used medications in the world. The intravenous format is the preferred method of administration in the intraoperative and immediate postoperative periods. In 100mL of solution for infusion, intravenous paracetamol contains the following: Paracetamol = 1g Mannitol = 3.91g Cysteine hydrochloride monohydrate Dibasic dihydrate sodium phosphate Sodium hydroxide Hydrochloric acid Water for injections The insertion of a pulmonary artery catheter (PAC) is required for routine anaesthesia treatment during cardiac surgery. Haemodynamic measurements will be monitored via the PAC. After insertion of the PAC, 100mL paracetamol (containing 1g paracetamol and 3.91g mannitol) will be administered intravenously. Volume of paracetamol to be administered: Actavis (North Adelaide, SA) recommends 1g of paracetamol per administration with a maximum of 4g of paracetamol per day. The minimum dose interval is 4 hours. The duration of infusion is 15 minutes. In this trial, a 1g of paracetamol will be administered every 6 hours, for 3 consecutive doses, which is in line with the manufacturer's recommendations. The first dose will be administered on arrival to the operating room, prior to induction of anaesthesia. The second dose will be administered 6 hours after the first, which may be near completion of surgery or in the intensive care unit. The final dose will be 6 hours later in the intensive care unit. The duration of each infusion will be set at 15 minutes. Paracetamol will be administered in addition to standard care analgesia. In accordance with strict hospital protocols, all doses of paracetamol administered will be recorded or logged on the participants analgesic chart.

Sponsors

Austin Hospital
Lead SponsorHospital

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

1. Adult surgery patients (age >18 years) 2. Cardiac surgery requiring cardiopulmonary bypass

Exclusion criteria

Paracetamol use 24 hours prior to surgery (in paracetamol only or in combination therapy) Pregnancy Chronic renal impairment (creatinine >250 umol/L) Chronic liver disease (ALT >200IU/L) Morbid obesity (BMI >35kg/m2) Known allergic reaction to IV paracetamol Consumption of caffeine (e.g. coffee or energy drinks), consumed within 10 hours of surgery

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026