Use of Oxycodone in Bariatric Surgery

NCT05515822 | Unknown Phase 4

• 1 other identifier: ezmr2022-018
• Study Type: interventional
• Target: 90
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Pain, Postoperative

Keywords

Oxycodone; Acute Postoperative Pain; clinical randomized trial

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (8)

• Postoperative nausea and vomiting

  Within 48 hours after surgery.

• Time to extubation

  Intraoperative (From the end of surgery to the removal of the endotracheal tube)

• Ramsay sedation score

  Within 48 hours after surgery.

• Finger pulse oxygen saturation (SpO2)

  Within 48 hours after surgery.

• Adverse effect

  During the hospital stay after surgery, an expected average of three days.

Study Arms (3)

Dezocine group

ACTIVE COMPARATOR

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

Oxycodone group

EXPERIMENTAL

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

Esketamine+Oxycodone group

EXPERIMENTAL

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

Interventions

Oxycodone Hydrochloride 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.

Also known as: Oxycodone group, Experimental

Oxycodone group

Dezocine 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.

Also known as: Dezocine group, Active Comparator

Dezocine group

Esketamine and Oxycodone 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.

Also known as: Esketamine+Oxycodone group, Experimental

Esketamine+Oxycodone group

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Qiang Fu: lead

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Oxycodone; dezocine; Esketamine

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Codeine; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Officials

• Qiang Fu

  The Third People's Hospital of Chengdu

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Qiang Fu

CONTACT

18981757992; fuqiang1878@outlook.com

Yu Zhang

CONTACT

17638734067; 1570115658@qq.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: Random numbers and groups are packed in opaque envelopes. The experimenter will open an envelope according to the random number on the envelope cover in the order from small to large according to the time of inclusion of the subject, and then obtain the random grouping of the subject (1:1:1). The random number is generated by computer, sealed into an envelope, unsealed and dispensed by professionals who do not participate in test operations. Participants and postoperative visitors did not know the grouping information. In emergency situations (e.g. allergies) or after data analysis.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chief Physician of Anesthesiology Department

Model Details: 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) .

Study Record Dates

• First Submitted: August 21, 2022
• First Posted: August 25, 2022
• Study Start: October 1, 2022
• Primary Completion: April 1, 2024
• Study Completion: September 1, 2024
• Last Updated: August 25, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share