Effect of Oxalidine Combined with Reduced-opioid Anesthesia on Multimodal Analgesia in Morbidly Obese Patients Undergoing Bariatric Surgery

NCT06712199 | Not Yet Recruiting Phase 4

• 1 other identifier: oxalidine
• Study Type: interventional
• Target: 124
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this study is to elucidate the efficacy and safety of oxelidine combined with oligopiate anesthesia for multi-modal analgesia in weight-loss surgery in morbidly obese patients, and to discover a new strategy for multi-modal analgesia management in weight-loss surgery, laying a foundation for the widespread application of oligopiate anesthesia in special patients. A total of 124 patients who underwent elective bariatric surgery in our hospital were selected, and the participants were randomly divided into two groups: the opioid anesthesia group (OBA group) and the low-opioid anesthesia group (OFA group) using a random number table to achieve simple randomization. Inclusion criteria: 1.ASA grade I \~ III; 2. Age ≥18 years old; 3. Bariatric surgery patients with BMI≥35kg/m2 and complex signs of morbid obesity (such as metabolic syndrome) 4. Sign the informed consent form. Exclusion criteria: 1. Positive pregnancy test or breastfeeding; 2. Patients with a history of substance abuse or dependence on opioids; 3. Patients with chronic pain or with severe heart, lung, liver or nervous system diseases. Anesthesia implementation: 1. Routine monitoring after entry, intravenous administration of midazolam and atropine. Study participants were placed in the ramp position, bilateral recurrent laryngeal nerve block under ultrasound guidance, and the mouth contained dachronine gel. Radial artery puncture was performed and dexmedetomidine was injected intravenously. A laryngeal tube is used to test the sensation of the back of the oropharynx, and a laryngeal mask is placed while awake to connect the anesthesia circuit and deliver oxygen. Once the vocal cords are seen and the end-respiratory CO2 waveform is observed. 2\. The OBA group underwent combined anesthesia induction with propofol, rocuronium bromide and sufentanil, endotracheal intubation through visual laryngeal mask, intraoperative pump injection of propofol and remifentanil to maintain anesthesia, sufentanil bridging 10μg 30 minutes before the end of the operation; In OFA group, propofol, rocuronium bromide and esketamine were induced by combined anesthesia, and endotracheal intubation was performed through visual laryngeal mask. Intraoperative pump propofol and esketamine to maintain anesthesia; Oxeridine was bridged-1.5 mg 30min before the operation and administered in two doses, 0.75mg/ time, with an interval of 10min. 3\. Both groups were subjected to bilateral lower costal margin transversal nerve block under ultrasound guidance. 4\. Ondansetron was given before the end of the operation. After the operation, the tracheal cannula was removed under deep anesthesia, and the laryngeal mask was retained and transferred to the postoperative resuscitation room. Sugengosaccharide sodium was used to antagonize muscle pine during recovery. After the study participants were awake, the laryngeal mask was well tolerated. The laryngeal mask was removed after observation for 1h, and the laryngeal mask was safely transferred to the ward after continuous observation for 1h. PCA administration regimen in OBA group: Sufentanil + dexmedetomidine + Ondansetron; OFA group PCA administration regimen: oxelidine + dexmedetomidine + Ondansetron. Record the number of compressions, if the assessment of NRS≥4 points, then remedy 2mg oxycodone hydrochloride, and record the dosage. Main outcome measures: Consumption of oral morphine equivalent (OME) opioids in the 24 hours prior to surgery. Secondary outcome measures: Overall satisfaction with analgesia and Numerical Rating Scale (NRS, 0-10) pain score, area under the curve of resting and exercise NRS score (AUC) within 72 hours after surgery, time to first use of rescue analgesics within 72 hours, cumulative opioid consumption 72 hours after surgery (morphine milligram equivalent, morphine milligram equivalent, NRS score) MME), participants' satisfaction with postoperative analgesia, 15-item Quality of Recovery score Scale (QoR15) at 24, 48, and 72h after surgery, incidence of postoperative complications, incidence of nausea and vomiting, and incidence of adverse events were recorded.

Conditions

Morbid Obesity

Keywords

Oxeridine; Hypopiate anesthesia; Multimodal analgesia; Morbid obesity

Outcome Measures

Primary Outcomes (1)

• Oral morphine equivalent (OME) opioid consumption in the 24 hours prior to surgery

  24 hours after surgery

Secondary Outcomes (1)

• Area under the NRS score curve at rest and exercise 72 hours after surgery (AUC)

  Within 72 hours after surgery

Other Outcomes (1)

• Overall satisfaction with analgesia and Numerical Rating Scale (NRS, 0-10) pain scores, study participants' satisfaction with postoperative analgesia, 15-item Quality of Recovery score Scale (QoR15) at 24, 48, and 72h after surgery

  72 hours after surgery

Study Arms (2)

Opioid Anesthesia Group (OBA Group)

PLACEBO COMPARATOR

In OBA group, propofol, rocuronium bromide and sufentanil were induced by combined anesthesia, tracheal intubation was performed through a visual laryngeal mask, propofol and remifentanil were injected into the intraoperative pump to maintain anesthesia, and sufentanil was brided to 10μg 30 minutes before the end of the operation. PCA administration regimen in OBA group: Sufentanil + dexmedetomidine + Ondansetron.

Drug: oxalidine

Less opioid anesthesia Group (OFA group)

EXPERIMENTAL

In OFA group, propofol, rocuronium bromide and esketamine were induced by combined anesthesia, and endotracheal intubation was performed through visual laryngeal mask. Intraoperative pump propofol and esketamine to maintain anesthesia; Oxeridine was bridged-1.5 mg 30min before the operation and administered in two doses, 0.75mg/ time, with an interval of 10min.

Drug: oxalidine

Interventions

oxalidine DRUG

Opioid anesthesia group (OBA group) Anesthesia was induced with propofol 2.5mg·kg-1, rocuronium 0.6mg·kg-1 and sufentanil 0.3μg·kg-1. When BIS value reached 40-60, tracheal intubation was performed through visual laryngeal mask airway. Anesthesia was maintained with propofol 4-12 mg·kg-1·h-1 and remifentanil 0.2-0.5 μg·kg-1·min-1. Sufentanil 10μg was bridaged 30min before the end of surgery. The PCA dosing regimen was sufentanil 2 µg/kg+ dexmedetomidine 2 µg/kg+ ondansetron 24mg. Reduced-opioid anesthesia group (OFA group) Anesthesia was induced with propofol 2.5mg·kg-1, rocuronium 0.6mg·kg-1 and esketamine 0.3mg·kg-1. When BIS value reached 40-60, tracheal intubation was performed through visual laryngeal mask airway. Propofol 4-12 mg·kg-1·h-1 and esketamine 0.3-0.5 mg·kg-1·h-1 were pumped to maintain anesthesia during operation. Oxalidine 1.5mg was given in two divided doses of 0.75mg each time with an interval of 10min 30min before the end of surgery. The PCA regimen was as follows:

Also known as: Less opioids for anesthesia

Less opioid anesthesia Group (OFA group); Opioid Anesthesia Group (OBA Group)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients undergoing weight loss surgery under general anesthesia;
• Age ≥18 years old;
• American Society of Anesthesiologists ASA Grade I-III;
• BMI≥35kg/m2 with complex signs of morbid obesity (such as metabolic syndrome)

You may not qualify if:

• Pregnancy test positive or breastfeeding;
• Patients with a history of substance abuse or dependence on opioids;
• Patients with chronic pain or with severe heart, lung, liver or nervous system diseases.

Sponsors & Collaborators

• Yongtao Sun: lead
• The First Hospital affiliated of Shandong First Medical University: collaborator

Study Sites (1)

Qianfoshan Hospital, The First Hospital affiliated of Shandong First Medical University

Jinan, Shandong, 250014, China

Location

MeSH Terms

Conditions

Obesity, Morbid

Interventions

Anesthesia

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anesthesia and Analgesia

Central Study Contacts

yong tao Sun, ph.d

CONTACT

18660795201; sunyongtao1979@163.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: November 25, 2024
• First Posted: December 2, 2024
• Study Start: January 1, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: December 2, 2024

Record last verified: 2024-11

Locations

CN (1)