RecruitingPhase 3ACTRN12620000198921

Improving the ways we put patients to sleep (anaesthesia) for weight loss surgery

SOOThe: Study of Obesity-reduction and Opiate-free Total Intravenous Anaesthesia (TIVA). Using TIVA in bariatric surgery improve the analgesia and reduce post operative nausea and vomiting.

Sponsor

Department of Anaesthesia

Enrollment

130 participants

Start Date

Nov 12, 2020

Study Type

Interventional

Conditions

Opiate Free Total Intravenous Anaesthesia Post Operative Acute Rehabilitation Obesity

Summary

Obesity is a major public health problem in both the developed and the developing world. A therapeutic approach that includes both bariatric surgery and medical management is more effective than medical management alone. However, bariatric patients are more prone to post operative complications that include post operative nausea and vomiting (PONV) and obstructive sleep apnea (OSA) both of which are caused by opiate administration. Despite the potential for both total intravenous anaesthesia (TIVA) and lignocaine infusions to reduce both of these morbidities there are few published reports in the literature on their use in bariatric patients. We propose to perform a pilot study in which patients are randomised to opiate free TIVA (Dexmedetomidine, Ketamine, Lignocaine and Propofol) or standard volatile-opiate based general anaesthesia and post operative care. We postulate that opiate free TIVA will provide improved analgesia, reduce PONV, cause less respiratory adverse events and lead to better post surgical rehabilitation. Ultimately we seek to establish a program of research which assesses the best method of Anaesthesia in Bariatric Patients. Pilot data will be used in grant applications to the Australian and New Zealand College of Anaesthetists (ANZCA) and the National Health and Medical Research Council (NHMRC).

Eligibility

Sex: Both males and femalesMin Age: 18 YearssMax Age: 75 Yearss

Plain Language Summary

Simplified for easier understanding

Weight loss surgery (bariatric surgery) is an effective treatment for severe obesity, but the anaesthesia used during the operation can sometimes cause problems like nausea and vomiting after surgery, or breathing difficulties during sleep recovery. Many of these problems are linked to opioid pain medications used during and after anaesthesia. This pilot study tests whether a completely opioid-free approach to anaesthesia — using a combination of medications including dexmedetomidine, ketamine, lignocaine, and propofol — is safer and more effective than the standard approach. Patients are randomly assigned to one of the two methods and monitored closely after surgery. You may be eligible if you are an adult aged 18–75 scheduled for elective stomach-reduction surgery. You are not eligible if you have chronic pain, significant heart disease, dementia, or known allergies to any of the study medications. The study is a small pilot designed to gather early data before a larger trial, and results will be used to seek funding for more extensive research.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

Opiate-Free TIVA General Anaesthesia Study Group : [1.1] Induction: Intravenous (IV) Dexmedetomidine (0.5mcg/kg over 10 minutes), IV Ketamine (0.5mg/kg), IV Lignocaine (1.0mg/kg (to a maximum of 200m

Opiate-Free TIVA General Anaesthesia Study Group : [1.1] Induction: Intravenous (IV) Dexmedetomidine (0.5mcg/kg over 10 minutes), IV Ketamine (0.5mg/kg), IV Lignocaine (1.0mg/kg (to a maximum of 200mg)) IV Propofol (Marsh TCI Cpt 4mcg/ml) and IV Vecuronium (0.1mg/kg). [1.2] Maintenance: IV Dexmedetomidine (0.5mcg/kg/hour), IV Ketamine (3mcg/kg/minute) and IV Lignocaine (1mg/kg/hour, to a maximum of 200mg/hour). [1.3] Addition multimodal analgesia will include IV Parecoxib 40mg and Paracetamol (IV, 1mg). Pantoprazole (40mg) intravenous will be given to reduce pain from gastro-oesphageal reflux. [1.4] IV Dexamethasone (0.2mg/kg to a maximum of 8mg), IV Droperidol (10mcg/kg, to a maximum of 600mcg) and IV Ondansetron (0.15mg/kg to a maximum of 4mg) will be administered intra-operatively. [1.5] Application of subcutaneous Bupivacaine to the surgical port sites by the surgeons [1.6] Reversal with IV Sugamaddex 200mg [1.7] Standard PACU protocols for IV Oxycodone (1mg, 2 minutely to a maximum of 10mg) will be prescribed and titrated to pain by PACU Staff. [1.8] Regular ondansetron (4mg every 8 hours waffer oral or IV) will be prescribed for the first 48 hours after surgery. Breakthrough anti-emetics of IV Metoclopramide 0.2mg/kg will be used. The depth of anaesthesia will be measured through Sedline Brain monitoring and the doses of drugs will be confirmed through study documentation and analysis of the anaesthetic chart.