None listed
Conditions
Brief summary
To compare QoR-40 scores twenty-four hours post-operatively in patients who have undergone general anaesthesia using propofol infusion as maintenance to those in whom sevoflurane inhalation is used as maintenance. To compare rates of nausea and vomiting, pain scores and opioid consumption twenty-four hours post-operatively in patients who have undergone general anaesthesia using intravenous agents only as maintenance to those in whom sevoflurane inhalation is used as maintenance. To achieve this, participants will be asked to complete Visual Analogue Scale (VAS) questionnaires, one for pain and one for nausea, at baseline and at the twenty-four hour post-operative visit.
Interventions
Induction:
Fentanyl 1-3 mcg/kg bolus at the discretion of treating anaesthetist
Propofol IV bolus TCI, Schnider model, effect site concentration (mcg/mL) at induction to be recorded on anaesthetic chart. Dose at the discretion of treating anaesthetist.
Rocuronium 0.6 mg/kg IV
Endotracheal intubation: Females 7.0 mm (Internal diameter) and males 8.0 mm
Maintenance:
Propofol IV TCI, Schnider model, effect site concentration recorded at 15 minute intervals on anaesthetic chart. Dose at the discret
Induction: Fentanyl 1-3 mcg/kg bolus at the discretion of treating anaesthetist Propofol IV bolus TCI, Schnider model, effect site concentration (mcg/mL) at induction to be recorded on anaesthetic chart. Dose at the discretion of treating anaesthetist. Rocuronium 0.6 mg/kg IV Endotracheal intubation: Females 7.0 mm (Internal diameter) and males 8.0 mm Maintenance: Propofol IV TCI, Schnider model, effect site concentration recorded at 15 minute intervals on anaesthetic chart. Dose at the discretion of treating anaesthetist. Record total dose of propofol (in mg) on anaesthetic chart. Maintenance anaesthesia titrated to BIS value 40 - 55. Dose at the discretion of treating anaesthetist Mechanical ventilation tidal volume 6 - 10 mL/kg, resp rate titrated to ETCO2 30 - 40 mmHg FiO2 0.5 (oxygen in air) Body temperature maintained at 36 - 37 degrees Celsius (forced air warmer) SBP maintained within 20% of pre-induction with use of fluids and vasopressor at anaesthetists discretion Fentanyl boluses at discretion of treating anaesthetist Rocuronium boluses at anaesthetist discretion Parecoxib 40mg before the end of surgery, unless contraindicated Reversal of rocuronium with neostigmine and glycopyrrolate dose at the discretion of the anaesthetist. Anti-emetics: all patients to receive dexamethasone 4 mg IV and ondansetron 4 mg IV and no further anti-emetics intra-operatively. PACU: Fentanyl 20mcg bolus for pain, repeated at discretion of treating nurse Anti-emetics at discretion of treating nurse, as charted by treating anaesthetist Ward recovery Oral oxycodone, 5-10 mg as required Morphine subcutaneous 5 mg as required for breakthrough pain Fentanyl PCA for participants with ongoing pain despite oral oxycodone and breakthrough morphine Anti-emetics at discretion of ward nursing staff, as charted by treating anaesthetist 1 g 4 times a day oral paracetamol commencing immediately post-operatively
Sponsors
Samuel Boyers
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
Male and female patients undergoing one- or two-level lumbar laminectomy or discectomy Age 18—65 BMI < 35 ASA 1-2 Willingness to give written consent and willingness to participate in and comply with the study.
Exclusion criteria
Patients with severe cardiovascular or respiratory disease Patients with a history of significant post-operative nausea and vomiting Patients with a history of psychological illness or condition such as to interfere with the patient’s ability to understand the requirements of the study Patients taking regular opioid medications in a total dose greater than the equivalent of morphine 20 mg orally in 24 hours Any known contraindication to either propofol intravenously or sevoflurane inhalationally Pregnant or breastfeeding women.
Outcome results
None listed