None listed
Conditions
Brief summary
Opioids are routinely used during surgery however opioids are associated with a range of side effects. As an alternative, opioid-free anaesthesia (OFA) is an emerging mode of anaesthesia intended to avoid these side effects. This study will utilise a randomised clinical trial to investigate the impact of OFA for patients having an elective laparoscopic cholecystectomy or tubal ligation. Patient outcomes to be measured include: • Quality of Recovery (QoR-15); • Oral Morphine Equivalent Daily Dose (OMEDD) at 24 hours post operatively; • Time to first opioid (TTFO) dose; • Post-operative nausea and vomiting (PONV); • Post Anaesthetic Care Unit (PACU) Length of stay (LOS); and • Hospital Length of stay (LOS).
Interventions
The intervention (Arm B) will receive opioid-free anaesthesia during laparascopic surgery
Opioid Free Anaesthesia induction
Anxiolytic agent: 1-5 minutes prior to induction Midazolam 1 – 3mg intravenously
Clonidine 1-3mcg/kg intravenously in 3 divided doses (at induction, mid surgery and end)
Rapid stress block: Lidocaine as per local protocols.
Induction hypnotic drug:
Propofol 1 – 2.5mg/kg intravenously bolus or as per programmed Target Control Infusion
Rapid preload reduction:
Magnesium
The intervention (Arm B) will receive opioid-free anaesthesia during laparascopic surgery Opioid Free Anaesthesia induction Anxiolytic agent: 1-5 minutes prior to induction Midazolam 1 – 3mg intravenously Clonidine 1-3mcg/kg intravenously in 3 divided doses (at induction, mid surgery and end) Rapid stress block: Lidocaine as per local protocols. Induction hypnotic drug: Propofol 1 – 2.5mg/kg intravenously bolus or as per programmed Target Control Infusion Rapid preload reduction: Magnesium sulphate 40 mg / kg (according to patient ideal body weight ) Anti-inflammatory agents : Single dose perioperatively of Intravenous Dexamethasone 8 mg and Parecoxib 40mg intravenously. Neuromuscular blocker (if needed for anaesthesia or surgery): Choice of any neuromuscular blocker is at the anaesthetist’s discretion. Beta-blocker: Esmolol 10 – 50mg IV bolus 20 seconds prior to intubation On standby intravenous bolus medications as required for hypotension; Ephedrine 3 mg/mL Phenylephrine 100mcg/mL Metaraminol 0.5mg/mL All perioperative drugs administered will be audited at day 1 post surgery with the patient total oral morphine equivalent daily dose (oMEDD) calculated.
Sponsors
Wide Bay Hospital and Health Service
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
Patients may be included in the study only if they meet all of the following criteria: • Aged 18 - 65 years • Independent capacity to consent to participate in trial • American Society of Anaesthesiologists (ASA) physical health score of I - II • Booked for elective laparoscopic cholecystectomy or tubal ligation (with or without oophorectomy)
Exclusion criteria
Patients who fulfil any of the following criteria are not eligible for admission to the study: • Pregnant women • Body Mass Index > 35 • Allergy to opioids • Allergy to adjuvant drugs • Persistent opioid use - patients with Oral Morphine Equivalent Daily Dose (OMEDD) greater than 0 during previous week pre-op and taken for 7 successive days or more including recreational drug use. • Non-elective surgery
Outcome results
None listed