Effect of Opioid-free Analgesia and Anesthesia on the Quality of Postoperative Recovery and Nausea Vomit in Patients Receiving Laparoscopic Sleeve Gastrectomy
- Conditions
- Opioid-Free AnesthesiaLaparoscopic Sleeve GastrectomyPostoperative VomitingPostoperative Recovery
- Interventions
- Drug: Opioid-free Analgesics (esketamine, dexmedetomidine)Drug: Opioid Anesthetics (sufentanil and remifentanil)
- Registration Number
- NCT06305221
- Lead Sponsor
- Beijing Friendship Hospital
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 76
-
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.
-
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Opioid-free group Opioid-free Analgesics (esketamine, dexmedetomidine) - Opioid group Opioid Anesthetics (sufentanil and remifentanil) -
- Primary Outcome Measures
Name Time Method 15-item recovery quality scale score 48 hours after surgery 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 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 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 Outcome Measures
Name Time Method Dosage of postoperative analgesics 48 hours after surgery record dosage of postoperative analgesics
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 The pain 0-10 classification is the numerical classification (NRS) of subjective assessment, with 0 painless pain, 1-3 mild pain, 4-6 moderate pain, 7-9 severe pain, and 10 severe pain. test acute pain numeric rating scale score at 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 recovery was defined by Aldrete's recovery score (RS, 0-10), assessed following postanesthesia care unit (PACU) arrival, with RS ≥9 considered discharge eligible
anesthesia-related complication 24 hours after surgery record anesthesia-related complication
Overall benefit of analgesic score satisfaction in pain treatment 6, 24, 48 hours after surgery To calculate the OBAS score, compute the sum of scores in items 1-6 and add '4-score in item 7'. Note that a low score indicates high benefit. test overall benefit of analgesic score satisfaction in pain treatment at 6, 24, 48 hours after surgery
Rhodes Index of Nausea, Vomiting, and Retching 6, 24, 48 hours after surgery Rhodes Index of Nausea, Vomiting, and Retching , an 8-item questionnaire, to measure the incidence and severity of nausea, vomiting, and retching At each timepoint, a total Rhodes score was calculated from the sum of the 8 RINVR questions. Total Rhodes scores were compared at 6 different timepoints as well as overall across all 6 time points. record Nausea and vomiting, the Rhodes index score. record Nausea and vomiting, the Rhodes index score
Trial Locations
- Locations (1)
bijia Song
🇨🇳Beijing, China