Use of Oxycodone in Bariatric Surgery

NCT ID: NCT05515822

Last Updated: 2022-08-25

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-01
• Study Completion Date: 2024-09-01

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.

Conditions

Pain, Postoperative

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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)

Group Type: ACTIVE_COMPARATOR

Dezocine

Intervention Type: DRUG

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.

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)

Group Type: EXPERIMENTAL

Oxycodone Hydrochloride

Intervention Type: DRUG

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.

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)

Group Type: EXPERIMENTAL

Esketamine and Oxycodone

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

Oxycodone group; Experimental; Dezocine group; Active Comparator; Esketamine+Oxycodone group; Experimental

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Qiang Fu

OTHER

Sponsor Role: lead

Responsible Party

Qiang Fu

Chief Physician of Anesthesiology Department

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Qiang Fu

Role: PRINCIPAL_INVESTIGATOR

The Third People's Hospital of Chengdu

Central Contacts

Qiang Fu

Role: CONTACT

fuqiang1878@outlook.com

18981757992

Yu Zhang

Role: CONTACT

1570115658@qq.com

17638734067

Other Identifiers

ezmr2022-018

Identifier Type: -

Identifier Source: org_study_id