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

Phase 3

Recruiting

• Conditions: Obesity; Post operative pain; Post Operative Nausea and Vomiting; Post Operative Acute Rehabilitation; Opiate Free Total Intravenous Anaesthesia; Anaesthesiology - Anaesthetics; Anaesthesiology - Pain management; Diet and Nutrition - Obesity; Respiratory - Sleep apnoea; Anaesthesiology - Other anaesthesiology

• Registration Number: ACTRN12620000198921
• Lead Sponsor: Department of Anaesthesia

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-02-20
• Last Update Posted: 13 June 2022

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 130

Inclusion Criteria

Elective, cognisant, adult patients booked for elective gastric reduction surgery

Exclusion Criteria

[1] Patients with a history of chronic pain
[2] Patients with a history of dementia or cognitive impairment
[3] Patients that do not wish to consent to the study
[4] Patients with a history of significant allergy or anaphylaxis to Ketamine, Propofol, Opiates and lignocaine
[5] Patients who are under 16 years of age or who are above 80 years of age

[6] Patients who plan not to be an inpatient for 48 hours following surgery
[7] Patients with a significant history of ischaemic heart disease (IHD) who have existing arrhythmias, low left or right ejection fraction (below 40%) or raised pulmonary blood pressure
[8] Patients already prescribed sodium channel blockers as part of the management of pre-existing IHD
[9] Pregnancy

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary outcome measure is the post operative pain measured by analgesic requirement as measured by the total dose of opiates used in PACU, days 1 and 2 on the surgical ward. <br>[PACU, Day 1 and Day 2 after surgery]

Secondary Outcome Measures

Name	Time	Method
Post operative pain as measured by the QoR-40 pain score <br><br>[PACU, Day 1 and Day 2 after surgery];PONV as measured by the prescription of additional anti-emetic doses used as measured by the total dose of anti-emetic medication required used in PACU, days 1 and 2 on the surgical ward. <br>[PACU, Day 1 and Day 2 after surgery];PONV as measured by the QoR-40 questionnaire in PACU<br>[PACU, Day 1 and Day 2 after surgery];The time taken to reach acute rehabilitation as measured by the QoR-40 questionnaire[PACU, Day 1 and Day 2 after surgery]