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Clinical Trials/NCT06305221
NCT06305221
Recruiting
Not Applicable

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

Beijing Friendship Hospital1 site in 1 country76 target enrollmentMarch 9, 2024

Overview

Phase
Not Applicable
Intervention
Opioid-free Analgesics (esketamine, dexmedetomidine)
Conditions
Opioid-Free Anesthesia
Sponsor
Beijing Friendship Hospital
Enrollment
76
Locations
1
Primary Endpoint
15-item recovery quality scale score 48 hours after surgery
Status
Recruiting
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 9, 2024
End Date
March 31, 2025
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Bijia Song

principal investigator

Beijing Friendship Hospital

Eligibility Criteria

Inclusion Criteria

  • 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.

Exclusion Criteria

  • 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

Arms & Interventions

Opioid-free group

Intervention: Opioid-free Analgesics (esketamine, dexmedetomidine)

Opioid group

Intervention: Opioid Anesthetics (sufentanil and remifentanil)

Outcomes

Primary Outcomes

15-item recovery quality scale score 48 hours after surgery

Time Frame: 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

15-item recovery quality scale score 24 hours before surgery

Time Frame: 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

15-item recovery quality scale score 24 hours after surgery

Time Frame: 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

Secondary Outcomes

  • Dosage of postoperative analgesics(48 hours after surgery)
  • time of first postoperative mobilization(24 hours after surgery)
  • time to first exhaust gas after surgery(24 hours after surgery)
  • Acute pain numeric rating scale score(6, 24, 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)
  • Overall benefit of analgesic score satisfaction in pain treatment(6, 24, 48 hours after surgery)
  • Rhodes Index of Nausea, Vomiting, and Retching(6, 24, 48 hours after surgery)

Study Sites (1)

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