Use of Oxycodone in Bariatric Surgery

Phase 4

Not yet recruiting

• Conditions: Pain, Postoperative
• Interventions: Drug: Oxycodone Hydrochloride; Drug: Esketamine and Oxycodone; Drug: Dezocine

• Registration Number: NCT05515822
• Lead Sponsor: Qiang Fu

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.

Study Timeline

• Status Verified: 2022-08
• Study First Submitted: 2022-08-21
• Study First Submitted QC: 2022-08-23
• Last Update Submitted: 2022-08-23
• Study First Posted: 2022-08-25
• Last Update Posted: 2022-08-25
• Study Start: 2022-10-01
• Primary Completion: 2024-04-01
• Study Completion: 2024-09-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 90

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Oxycodone group	Oxycodone Hydrochloride	Oxycodone (1ml: 10mg) was administered 30 minutes before the end of surgery (0.15mg/kg i.v.) and during patient controlled intravenous analgesia (Oxycodone 30mg+ Tropisetron 10mg+Saline, total 200ml)
Esketamine+Oxycodone group	Esketamine and Oxycodone	Esketamine (2ml: 50mg) was administered 5 minutes before incision (0.15mg/kg i.v.), while Oxycodone was administered 30 minutes before the end of surgery (0.15mg/kg i.v.) and during patient controlled intravenous analgesia (Oxycodone 30mg+ Tropisetron 10mg+Saline, total 200ml)
Dezocine group	Dezocine	Dezocine (1ml: 5mg) was administered 30 minutes before the end of surgery (0.15mg/kg i.v.) and during patient controlled intravenous analgesia (Dezocine 30mg+ Tropisetron 10mg+Saline, total 200ml)

Primary Outcome Measures

Name	Time	Method
Changes in postoperative pain	Within 48 hours after surgery.	The Visual analogue Scale (VAS) was used to evaluate the intensity of postoperative resting state, motor state, and visceral pain within 48 hours after surgery. VAS ranges from 0 to 10, where 0 represents no pain and 10 represents excruciating pain, with higher scores indicating greater pain.
Postoperative opioid consumption	Within 48 hours after surgery.	The total postoperative opioid consumption was recorded within 48 hours after surgery. Postoperative opioid consumption was evaluated using intravenous morphine equivalent (IVME).

Secondary Outcome Measures

Name	Time	Method
Postoperative nausea and vomiting	Within 48 hours after surgery.	Postoperative nausea and vomiting (PONV) was evaluated within 48 hours after surgery. 11-point verbal numeric rating scale (VNRS) was used to evaluate nausea (none:0, mild: 1-3, moderate:4-6, severe 7-10). Vomiting was considered a condition of retching symptom or the presence of vomit.
Time to extubation	Intraoperative (From the end of surgery to the removal of the endotracheal tube)	The total extubation time from the end of surgery to the removal of the endotracheal tube was evaluated after surgery.
Ramsay sedation score	Within 48 hours after surgery.	Ramsay sedation score was evaluated within 48 hours after surgery. Ramsay sedation score from 1 to 6, with higher scores indicating deeper the sedation.
Finger pulse oxygen saturation (SpO2)	Within 48 hours after surgery.	Finger pulse oxygen saturation (SpO2) was evaluated within 48 hours after surgery.
Adverse effect	During the hospital stay after surgery, an expected average of three days.	Perioperative adverse effects such as shivering, blurred vision, headache, dizziness, dry mouth, respiratory depression during postoperative to discharge.
Total amount of anesthetic drugs used	Intraoperative (During the whole bariatric surgery)	Total amount of anesthetic drugs Propofol, Remifentanil and (or) sevoflurane used was evaluated during the whole surgery.
First time to get out of bed after surgery	During the hospital stay after surgery, an expected average of three days.	First time to get out of bed after surgery was evaluated after surgery.
Total length of stay	During the hospital stay after surgery, an expected average of three days.	Total length of stay was evaluated from postoperative to discharge.