NCT03756961 Effects of an Opioid Free/Sparing Care Pathway for Patients Undergoing Obesity Surgery
| NCT ID | NCT03756961 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Göteborg University |
| Condition | Obesity |
| Study Type | INTERVENTIONAL |
| Enrollment | 220 participants |
| Start Date | 2019-05-01 |
| Primary Completion | 2028-05-31 |
Eligibility & Interventions
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 220 participants in total. It began in 2019-05-01 with a primary completion date of 2028-05-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The opioid consumption has exploded in the western world, and for some patient populations such as obese patients, patients with sleep apnoea or patients undergoing cancer treatment, opioid-sparing/ opioid-free strategies could have positive effects on outcomes. Studies suggest that opioids could have opioid-induced immunosuppression, induce chronic post-operative pain syndrome and hyperalgesia in addition to the more well-known side effects such as respiratory depression, nausea, bladder, and bowel dysfunction. Hence, new studies are needed on the impact of person-centered care programs that combine pharmaceutical and non-pharmaceutical strategies to reduce the adverse short and long-term effects of opioid therapy. The overall aim is to evaluate the short-, medium- and long-term effects of opioid-free care pathways with or without person-centred care compared to conventional opioid-based treatment in patients undergoing obesity surgery. Specific aims 1. Determine the effects of opioid-free care with or without person-centred care compared with conventional opioid-based general anaesthesia on the cognitive and physical quality of recovery after surgery up to 24 months after surgery (short-term: postoperative to discharge, medium-term: 14 days, 3 months, long-term: 6 months, 12 months and 24 months). 2. Describe the clinical monitoring trend regarding nociceptive response intraoperatively between opioid-free and conventional care. 3. Map the impact of opioid-free anaesthesia (with and without person-centred care) on the usage of opioids up to 24 months after hospital discharge. 4. Explore the patients' experience of quality of life, economic evaluations, self-efficacy and recovery after surgery in opioid-free care with or without person-centred care during the first year post-surgery. The aims will be evaluated by a prospective, randomized, non-blinded, non-commercial multi-centre study (Nov 2018-Dec 2022) approved by the Swedish Medicines Agency (EU-CT 2023-505934-86-00) and the ethical review board (DNR 1006-17).
Eligibility Criteria
Inclusion Criteria: -Patients ≥18 years planned to undergo laparoscopic obesity surgery (GBP alt Sleeve surgery) at the selected site. Exclusion Criteria: * ASA\> III * Cardiovascular disease with bradycardia (\<50 bpm) * Serious liver disease failure * Insufficient knowledge of the Swedish language * Serious untreated psychiatric disease * Neurocognitive dysfunction * Pregnancy * Women of childbearing age without contraception * Malignant disease with expected short survival * Patients treated with opioids for chronic pain * Substance abuse * Hypersensitivity to Oxycodone, Esketamine, Dexmedetomidine, and Lidocaine * Pacemaker or ICD * Inability to fill in questionnaires * Decline participation,
Contact & Investigator
Sven-Egron Thörn, MD, PhD
PRINCIPAL INVESTIGATOR
Göteborg University
Frequently Asked Questions
Who can join the NCT03756961 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Obesity. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT03756961 currently recruiting?
Yes, NCT03756961 is actively recruiting participants. Contact the research team at axel.wolf@gu.se for enrollment information.
Where is the NCT03756961 trial being conducted?
This trial is being conducted at Lindesberg, Sweden, Gothenburg, Sweden.
Who is sponsoring the NCT03756961 clinical trial?
NCT03756961 is sponsored by Göteborg University. The principal investigator is Sven-Egron Thörn, MD, PhD at Göteborg University. The trial plans to enroll 220 participants.
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