Clinical trial NCT06305221: Effect of Opioid-free Analgesia and Anesthesia on the Quality of Postoperative Recovery and Nausea Vomit in Patients Receiving Laparoscopic Sleeve Gastrectomy
Official title: Effect of Opioid-free Analgesia and Anesthesia on the Quality of Postoperative Recovery and Nausea Vomit in Patients Receiving Laparoscopic Sleeve Gastrectomy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Opioid-Free Anesthesia
Laparoscopic Sleeve Gastrectomy
Postoperative Vomiting
Postoperative Recovery
Lead sponsor: Beijing Friendship Hospital
Sponsor class: OTHER
First posted: 2024-03-12
Enrollment: 76
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: 15-item recovery quality scale score 48 hours after surgery
timeFrame: 48 hours after surgery
measure: 15-item recovery quality scale score 24 hours before surgery
timeFrame: 24 hours before surgery
measure: 15-item recovery quality scale score 24 hours after surgery
timeFrame: 24 hours after surgery
Secondary outcomes:
measure: Dosage of postoperative analgesics
timeFrame: 48 hours after surgery
measure: Duration of until postoperative PACU Aldrete score> 9 points
timeFrame: up to 30 min after surgery at postoperative recovery room
measure: anesthesia-related complication
timeFrame: 24 hours after surgery
measure: time to first exhaust gas after surgery
timeFrame: 24 hours after surgery
measure: time of first postoperative mobilization
timeFrame: 24 hours after surgery
measure: Overall benefit of analgesic score satisfaction in pain treatment
timeFrame: 6, 24, 48 hours after surgery
measure: Acute pain numeric rating scale score
timeFrame: 6, 24, 48 hours after surgery
measure: Rhodes Index of Nausea, Vomiting, and Retching
timeFrame: one night before surgery
measure: Rhodes Index of Nausea, Vomiting, and Retching
timeFrame: 6, 24, 48 hours after surgery
Other outcomes:
Locations:
city: Beijing
country: China
facility: bijia Song
Study officials:
References: