Clinical trial NCT05515822: Use of Oxycodone in Bariatric Surgery
Official title: Use of Oxycodone in Multimodel Perioperative Analgesia of Bariatric Surgery and Its Effect on Inflammatory Factors
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Pain, Postoperative
Keywords: Oxycodone
Acute Postoperative Pain
clinical randomized trial
Lead sponsor: The Third People's Hospital of Chengdu
Sponsor class: OTHER
First posted: 2022-08-25
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Control group: Dezocine +Patient-controlled intravenous analgesia (Dezocine) ; Intervention group A: Oxycodone +Patient-controlled intravenous analgesia (Oxycodone); Intervention group B: Esketamine + Oxycodone +Patient-controlled intravenous analgesia (Oxycodone) .
Primary purpose: TREATMENT

Brief summary: There is still no effective treatment for surgical pain, especially visceral pain in bariatric surgery. Oxycodone has great application prospect in patients with obesity, but there are few clinical studies and analgesic effect is still unclear, especially in combination with esketamine.

This study was a prospective, single-center, randomized, controlled, double-blind clinical trial to compare the efficacy and safety of intravenous oxycodone and combined use of esketamine for perioperative multimodel analgesia during bariatric surgery, and the effect of esketamine on inflammatory factors.

This study was based on the hypothesis that oxycodone and the combination use with esketamine can effectively reduce the level of postoperative pain and inflammatory factors, and does not increase perioperative adverse reactions in bariatric surgery.

Detailed description: The ideal analgesia for bariatric surgery in obese individuals is one that provides effective analgesia for gastrointestinal trauma and abdominal wall incisions without inhibiting respiratory and gastrointestinal recovery. Although many researches have been done on surgical analgesia, there is still no very effective treatment for pain caused by surgery, especially visceral pain.

Oxycodone is a new type of opioid with pure μ and κ receptor double agonists. κ-receptor agonist has specific analgesic effect on visceral pain. Studies have found that oxycodone has obvious effect on visceral pain after abdominal surgery, and at the same time, oxycodone almost does not affect respiration and gastrointestinal peristalsis, which has great application prospect in obese people. However, opioids (including oxycodone) can cause drug tolerance and hyperalgesia, which may be mediated by NMDA receptor activation in the central nervous system. Esketamine provides exact analgesic effect by antagonizing NMDA receptors, with mild respiratory depression and less gastrointestinal and psychiatric adverse reactions. As an analgesic adjuvant, it can reduce the consumption of opioids and increase the analgesic effect when used in combination with other drugs.

Therefore, a prospective, single-center, randomized, controlled, double-blind trial was designed to compare the efficacy and safety of intravenous oxycodone plus esketamine for perioperative multimodal analgesia and the effects on inflammatory cytokines levels during bariatric surgery.

Participants were divided into an intervention group with oxycodone or (and) esketamine, and a control group with dezocine. The main concerns are the effectiveness of postoperative analgesia and the occurrence of adverse reactions.

Eligibility criteria: Inclusion Criteria:

* Body mass index (BMI) ≥30kg/m2;
* Laparoscopic sleeve gastrectomy (LSG) was performed;
* American Society of Anesthesiologists (ASA) Grade I to II, age: 18-50;
* Patient-controlled intravenous analgesia (PCIA) was approved.

Exclusion Criteria:

* Do not agree to sign informed consent or cannot sign for other reasons;
* Oxycodone contraindications;
* Patients with contraindications to esketamine;
* Disocine contraindications;
* Preoperative history of opioid allergy and abuse;
* Have a long history of alcoholism;
* A history of surgery or anesthesia recently;
* Changes in standard anesthesia procedures for any reason.

Primary outcomes:
measure: Changes in postoperative pain
timeFrame: Within 48 hours after surgery.
measure: Postoperative opioid consumption
timeFrame: Within 48 hours after surgery.
Secondary outcomes:
measure: Postoperative nausea and vomiting
timeFrame: Within 48 hours after surgery.
measure: Time to extubation
timeFrame: Intraoperative (From the end of surgery to the removal of the endotracheal tube)
measure: Ramsay sedation score
timeFrame: Within 48 hours after surgery.
measure: Finger pulse oxygen saturation (SpO2)
timeFrame: Within 48 hours after surgery.
measure: Adverse effect
timeFrame: During the hospital stay after surgery, an expected average of three days.
measure: Total amount of anesthetic drugs used
timeFrame: Intraoperative (During the whole bariatric surgery)
measure: Total length of stay
timeFrame: During the hospital stay after surgery, an expected average of three days.
measure: First time to get out of bed after surgery
timeFrame: During the hospital stay after surgery, an expected average of three days.
Other outcomes:
Locations:
Study officials:
affiliation: The Third People's Hospital of Chengdu
name: Qiang Fu
role: PRINCIPAL_INVESTIGATOR
References: