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

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Capital Medical University

Status

Enrolling

Conditions

Opioid-Free Anesthesia
Postoperative Recovery
Laparoscopic Sleeve Gastrectomy
Postoperative Vomiting

Treatments

Drug: Opioid Anesthetics (sufentanil and remifentanil)
Drug: Opioid-free Analgesics (esketamine, dexmedetomidine)

Study type

Interventional

Funder types

Other

Identifiers

NCT06305221
opioid-free analgesia

Details and patient eligibility

About

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.

Enrollment

76 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

76 participants in 2 patient groups

Opioid-free group
Experimental group
Treatment:
Drug: Opioid-free Analgesics (esketamine, dexmedetomidine)
Opioid group
Active Comparator group
Treatment:
Drug: Opioid Anesthetics (sufentanil and remifentanil)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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