Effect of Opioid-free Analgesia and Anesthesia on the Quality of Postoperative Recovery and Nausea Vomit in Patients Receiving Laparoscopic Sleeve Gastrectomy

NCT06305221 | Recruiting

• 1 other identifier: opioid-free analgesia
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the intraoperative use of opioids is to reduce the amount of sedative medication and to ensure effective analgesia. But pain is an unpleasant sensory and emotional experience (a cognitive perception) that cannot occur with sufficient depth of anesthesia (even without opioids). So a more reasonable explanation for analgesia should be anti-nociception and the resulting inhibition of the response to surgical stress. Since multiple mediators are involved in nociceptive pathways, antinociception can also be acquired through multiple mechanisms. However, there is no single ideal harm drug to replace opioids, which often requires two or more drugs to meet clinical needs. While regional block attenuates the stress response to surgery and sympathetic activation because of afferents to block nociceptive stimuli, and has an important role in the implementation of OFA. Combined with the clinical characteristics of the LSG, investigators developed the transverse abdominis fascia block (transversus abdominis plane TAP) in combination with esketamine (esketamine), dexmedetomidine (dexmedetomidine, DEX) of opioid-free anesthesia (opioid free anesthesia, OFA) and the analgesic regimen (TEDOFA), Reduce patient pain scores, nausea and vomiting after LSG based on perfect analgesia and adequate anti-sympathetic response, As well as the other complications, Promote the accelerated postoperative recovery of patients undergoing LSG, And reduce the incidence and severity of postoperative chronic pain.

Conditions

Opioid-Free Anesthesia; Laparoscopic Sleeve Gastrectomy; Postoperative Vomiting; Postoperative Recovery

Outcome Measures

Primary Outcomes (3)

• 15-item recovery quality scale score 48 hours after surgery

  The QoR-15 scale is a global measure of postoperative recovery, with scores ranging from 0 (extremely poor QoR) to 150 (excellent QoR). QoR-15 has become the most widely reported indicator for the evaluation of postoperative life treatment in patients. Using wherever possible QoR-15 item scores on postoperative day 3, QoR-15 with very good validity, and good reliability, responsiveness and clinical acceptability, these data suggest that QoR-15 is an excellent patient-centered measure of postoperative QoR. Patient Acceptable symptom status describes the lowest absolute score considered by the patient to represent a healthy or good status health scale. A QoR-15 score of 118 or more indicates a good postoperative recovery

  48 hours after surgery

• 15-item recovery quality scale score 24 hours before surgery

  The QoR-15 scale is a global measure of postoperative recovery, with scores ranging from 0 (extremely poor QoR) to 150 (excellent QoR). QoR-15 has become the most widely reported indicator for the evaluation of postoperative life treatment in patients. Using wherever possible QoR-15 item scores on postoperative day 3, QoR-15 with very good validity, and good reliability, responsiveness and clinical acceptability, these data suggest that QoR-15 is an excellent patient-centered measure of postoperative QoR. Patient Acceptable symptom status describes the lowest absolute score considered by the patient to represent a healthy or good status health scale. A QoR-15 score of 118 or more indicates a good postoperative recovery

  24 hours before surgery

• 15-item recovery quality scale score 24 hours after surgery

  The QoR-15 scale is a global measure of postoperative recovery, with scores ranging from 0 (extremely poor QoR) to 150 (excellent QoR). QoR-15 has become the most widely reported indicator for the evaluation of postoperative life treatment in patients. Using wherever possible QoR-15 item scores on postoperative day 3, QoR-15 with very good validity, and good reliability, responsiveness and clinical acceptability, these data suggest that QoR-15 is an excellent patient-centered measure of postoperative QoR. Patient Acceptable symptom status describes the lowest absolute score considered by the patient to represent a healthy or good status health scale. A QoR-15 score of 118 or more indicates a good postoperative recovery

  24 hours after surgery

Secondary Outcomes (9)

• Dosage of postoperative analgesics

  48 hours after surgery

• Duration of until postoperative PACU Aldrete score> 9 points

  up to 30 min after surgery at postoperative recovery room

• anesthesia-related complication

  24 hours after surgery

• time to first exhaust gas after surgery

  24 hours after surgery

• time of first postoperative mobilization

  24 hours after surgery

Study Arms (2)

Opioid-free group

EXPERIMENTAL

Drug: Opioid-free Analgesics (esketamine, dexmedetomidine)

Opioid group

ACTIVE COMPARATOR

Drug: Opioid Anesthetics (sufentanil and remifentanil)

Interventions

Opioid-free Analgesics (esketamine, dexmedetomidine) DRUG

opioid free group: After infusion of a loading dose of dexmedetomidine, intravenous midazolam 2mg, propofol 2mg kg-1, esketamine 0.5 mg kg-1, rocuronium 0.6-1mg kg-1, and 3min after endotracheal intubation. Intravenous continuous infusion of propofol, esketamine and dexmedetomidine hydrochloride mixture (esketamine 50mg + dexmedetomidine hydrochloride 150 ug + 0.9% saline 50ml in the same 50ml syringe) 0.1ml kg-1 h-1-0.2 ml kg-1 h-1 (equivalent to esketamine 0.1-0.2mg kg-1 h-1; Dexmedetomidine hydrochloride 0.3-0.6 μ g kg-1 h-1) maintains a BIS value between 40-60, 10-20mg / time was added as appropriate.

Opioid-free group

Opioid Anesthetics (sufentanil and remifentanil) DRUG

Intravenous midazolam 2mg, propofol 2mg kg-1, sufentanyl 0.3-0.5 μ g kg-1, rocuronium 0.6-1mg kg-1,3min before endotracheal intubation. After successful endotracheal intubation, continuous intravenous infusion of propofol and remifentanil was started to maintain BIS values between 40-60, and rocuronium 10-20mg / time as appropriate. After the start of surgery, 10-20 μ g of sufentanil was added according to blood pressure and heart rate. At the end of the operation, 5mg and 50mg were injected before the end of the operation, and propofol and remifentanil were stopped at the end of the operation

Opioid group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients undergoing elective laparoscopic sleeve gastrectomy
• ASAA I or grade;
• volunteered in this trial and signed informed consent; ④ age 18-65 years; ⑤ BMI\> 30kg / m2.

You may not qualify if:

• chronic pain;
• severe liver dysfunction (total bilirubin 2 mg dl-1);
• severe renal dysfunction (glomerular filtration rate 60ml min-1 1.73m-2);
• pregnancy or lactation;
• preoperative heart rate \<50 beats / min, sick sinus syndrome, severe heart block; -dementia or significant neurological disorders (such as stroke, epilepsy, intracranial tumors, PD, etc.);
• history of alcohol or drug abuse

Sponsors & Collaborators

• Beijing Friendship Hospital: lead

Study Sites (1)

bijia Song

Beijing, China

RECRUITING

MeSH Terms

Conditions

Postoperative Nausea and Vomiting

Interventions

Esketamine; Dexmedetomidine; Sufentanil; Remifentanil

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Nausea; Signs and Symptoms, Digestive; Signs and Symptoms; Vomiting

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fentanyl; Piperidines; Propionates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: March 3, 2024
• First Posted: March 12, 2024
• Study Start: March 9, 2024
• Primary Completion: March 31, 2025
• Study Completion: March 31, 2025
• Last Updated: May 9, 2024

Record last verified: 2024-05

Locations

CN (1)