Use of Oxycodone in Bariatric Surgery

Use of Oxycodone in Multimodel Perioperative Analgesia of Bariatric Surgery and Its Effect on Inflammatory Factors

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Pain, Postoperative
• Intervention / Treatment: Drug: Dezocine; Drug: Oxycodone Hydrochloride; Drug: Esketamine and Oxycodone

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 Type: Interventional
• Enrollment (Anticipated): 90
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Qiang Fu; Phone Number: 18981757992; Email: fuqiang1878@outlook.com
• Study Contact Backup: Name: Yu Zhang; Phone Number: 17638734067; Email: 1570115658@qq.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 48 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Dezocine group; 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)	Drug: Dezocine; Dezocine was administered within 30min before the end of surgery. The parameters of patient controlled intravenous analgesia (PCIA) pump were set as continuous volume: 0ml, PCA: 6ml, lock time: 5min, extreme limit: 30ml, and connect with peripheral venous access at the beginning of skin suture.; Other Names: Active Comparator; Dezocine group
Experimental: Oxycodone group; 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)	Drug: Oxycodone Hydrochloride; The doses were calculated according to the ideal body weight. Oxycodone was administered within 30min before the end of surgery. The parameters of patient controlled intravenous analgesia (PCIA) pump were set as continuous volume: 0ml, PCA: 6ml, lock time: 5min, extreme limit: 30ml, and connect with peripheral venous access at the beginning of skin suture.; Other Names: Experimental; Oxycodone group
Experimental: Esketamine+Oxycodone group; 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)	Drug: Esketamine and Oxycodone; Esketamine was administered 5min before skin incision, and Oxycodone was administered within 30min before the end of surgery. The parameters of patient controlled intravenous analgesia (PCIA) pump were set as continuous volume: 0ml, PCA: 6ml, lock time: 5min, extreme limit: 30ml, and connect with peripheral venous access at the beginning of skin suture.; Other Names: Experimental; Esketamine+Oxycodone group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in postoperative pain	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.	Within 48 hours after surgery.
Postoperative opioid consumption	The total postoperative opioid consumption was recorded within 48 hours after surgery. Postoperative opioid consumption was evaluated using intravenous morphine equivalent (IVME).	Within 48 hours after surgery.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative nausea and vomiting	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.	Within 48 hours after surgery.
Time to extubation	The total extubation time from the end of surgery to the removal of the endotracheal tube was evaluated after surgery.	Intraoperative (From the end of surgery to the removal of the endotracheal tube)
Ramsay sedation score	Ramsay sedation score was evaluated within 48 hours after surgery. Ramsay sedation score from 1 to 6, with higher scores indicating deeper the sedation.	Within 48 hours after surgery.
Finger pulse oxygen saturation (SpO2)	Finger pulse oxygen saturation (SpO2) was evaluated within 48 hours after surgery.	Within 48 hours after surgery.
Adverse effect	Perioperative adverse effects such as shivering, blurred vision, headache, dizziness, dry mouth, respiratory depression during postoperative to discharge.	During the hospital stay after surgery, an expected average of three days.
Total amount of anesthetic drugs used	Total amount of anesthetic drugs Propofol, Remifentanil and (or) sevoflurane used was evaluated during the whole surgery.	Intraoperative (During the whole bariatric surgery)
Total length of stay	Total length of stay was evaluated from postoperative to discharge.	During the hospital stay after surgery, an expected average of three days.
First time to get out of bed after surgery	First time to get out of bed after surgery was evaluated after surgery.	During the hospital stay after surgery, an expected average of three days.

Collaborators and Investigators

• Sponsor: Qiang Fu
• Investigators: Principal Investigator: Qiang Fu, the Third People's Hospital of Chengdu

Study record dates

Study Major Dates

• Study Start (Anticipated): October 1, 2022
• Primary Completion (Anticipated): April 1, 2024
• Study Completion (Anticipated): September 1, 2024

Study Registration Dates

• First Submitted: August 21, 2022
• First Submitted That Met QC Criteria: August 23, 2022
• First Posted (Actual): August 25, 2022

Study Record Updates

• Last Update Posted (Actual): August 25, 2022
• Last Update Submitted That Met QC Criteria: August 23, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: Oxycodone; Acute Postoperative Pain; clinical randomized trial
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Opioid; Narcotics; Psychotropic Drugs; Antidepressive Agents; Esketamine; Oxycodone; Dezocine
• Other Study ID Numbers: ezmr2022-018

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: The results of the study will be published in the form of a paper, and the information of specific participants will be kept confidential.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No