drugset / Trial / NCT06305221

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

NCT06305221

Unknown 76 enrolled Beijing Friendship Hospital
RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start
2024-03-09
Primary completion
2025-03-31
Completion
2025-03-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Dexmedetomidine Other / unclassified 0.3 ug/kg Intravenous
Subject Dexmedetomidine Other / unclassified 0.6 ug/kg Intravenous
Subject Esketamine Other / unclassified 0.1 mg/kg Intravenous
Subject Esketamine Other / unclassified 0.2 mg/kg Intravenous
Comparator Remifentanil Small molecule Intravenous
Comparator Sufentanil Other / unclassified 0.3 ug/kg Intravenous
Comparator Sufentanil Other / unclassified 0.5 ug/kg Intravenous
Comparator Sufentanil Other / unclassified 10 ug Intravenous
Comparator Sufentanil Other / unclassified 20 ug Intravenous
Background Midazolam Small molecule 2 mg Intravenous
Background Propofol Small molecule 2 mg/kg Intravenous
Background Rocuronium Other / unclassified 0.6 mg/kg Intravenous
Background Rocuronium Other / unclassified 1 mg/kg Intravenous
Background Rocuronium Other / unclassified 10 mg Intravenous