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

NCT ID: NCT06305221

Last Updated: 2024-05-09

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 76 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-09
• Study Completion Date: 2025-03-31

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.

Conditions

Opioid-Free Anesthesia; Laparoscopic Sleeve Gastrectomy; Postoperative Vomiting; Postoperative Recovery

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Opioid-free group

Group Type: EXPERIMENTAL

Opioid-free Analgesics (esketamine, dexmedetomidine)

Intervention Type: DRUG

opioid free group: After infusion of a loading dose of dexmedetomidine, intravenous midazolam 2mg, propofol 2mg kg-1, esketamine 0.5 mg kg-1, rocuronium 0.6-1mg kg-1, and 3min after endotracheal intubation. Intravenous continuous infusion of propofol, esketamine and dexmedetomidine hydrochloride mixture (esketamine 50mg + dexmedetomidine hydrochloride 150 ug + 0.9% saline 50ml in the same 50ml syringe) 0.1ml kg-1 h-1-0.2 ml kg-1 h-1 (equivalent to esketamine 0.1-0.2mg kg-1 h-1; Dexmedetomidine hydrochloride 0.3-0.6 μ g kg-1 h-1) maintains a BIS value between 40-60, 10-20mg / time was added as appropriate.

Opioid group

Group Type: ACTIVE_COMPARATOR

Opioid Anesthetics (sufentanil and remifentanil)

Intervention Type: DRUG

Intravenous midazolam 2mg, propofol 2mg kg-1, sufentanyl 0.3-0.5 μ g kg-1, rocuronium 0.6-1mg kg-1,3min before endotracheal intubation. After successful endotracheal intubation, continuous intravenous infusion of propofol and remifentanil was started to maintain BIS values between 40-60, and rocuronium 10-20mg / time as appropriate. After the start of surgery, 10-20 μ g of sufentanil was added according to blood pressure and heart rate. At the end of the operation, 5mg and 50mg were injected before the end of the operation, and propofol and remifentanil were stopped at the end of the operation

Interventions

Opioid-free Analgesics (esketamine, dexmedetomidine)

opioid free group: After infusion of a loading dose of dexmedetomidine, intravenous midazolam 2mg, propofol 2mg kg-1, esketamine 0.5 mg kg-1, rocuronium 0.6-1mg kg-1, and 3min after endotracheal intubation. Intravenous continuous infusion of propofol, esketamine and dexmedetomidine hydrochloride mixture (esketamine 50mg + dexmedetomidine hydrochloride 150 ug + 0.9% saline 50ml in the same 50ml syringe) 0.1ml kg-1 h-1-0.2 ml kg-1 h-1 (equivalent to esketamine 0.1-0.2mg kg-1 h-1; Dexmedetomidine hydrochloride 0.3-0.6 μ g kg-1 h-1) maintains a BIS value between 40-60, 10-20mg / time was added as appropriate.

Intervention Type: DRUG

Opioid Anesthetics (sufentanil and remifentanil)

Intravenous midazolam 2mg, propofol 2mg kg-1, sufentanyl 0.3-0.5 μ g kg-1, rocuronium 0.6-1mg kg-1,3min before endotracheal intubation. After successful endotracheal intubation, continuous intravenous infusion of propofol and remifentanil was started to maintain BIS values between 40-60, and rocuronium 10-20mg / time as appropriate. After the start of surgery, 10-20 μ g of sufentanil was added according to blood pressure and heart rate. At the end of the operation, 5mg and 50mg were injected before the end of the operation, and propofol and remifentanil were stopped at the end of the operation

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Beijing Friendship Hospital

OTHER

Sponsor Role: lead

Responsible Party

Bijia Song

principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

bijia Song

Beijing, , China

Site Status: RECRUITING

Countries

China

Facility Contacts

bijia Song

Role: primary

songbijia@163.com

18309845273

Other Identifiers

opioid-free analgesia

Identifier Type: -

Identifier Source: org_study_id