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Effects of perioperative using esketamine on opioid dose and acute and chronic pain in patients undergoing laparoscopic sleeve gastrectomy: a single-center, randomized, double-blind, placebo-controlled study

Effects of perioperative using esketamine on opioid dose and acute and chronic pain in patients undergoing laparoscopic sleeve gastrectomy: a single-center, randomized, double-blind, placebo-controlled study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200066659
Enrollment
Unknown
Registered
2022-12-13
Start date
2022-12-19
Completion date
Unknown
Last updated
2023-05-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients with acute and chronic pain after laparoscopic sleeve gastrectomy

Interventions

S Group:Sufentanil + Esketamine
C Gruop:Sufentanil + Sodium chloride injection

Sponsors

The Third Xiangya Hospital of Central South University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1.Aged 18-65 years; 2.ASA I - ? level; 3.Elective laparoscopic sleeve gastrectomy; 4.Patients voluntarily participated in the study and signed written informed consent

Exclusion criteria

Exclusion criteria: 1. history of chronic pain ( >3 months ); 2. Severe disease (ASA grade =IV), severe renal insufficiency (preoperative dialysis), severe liver insufficiency (Chlid-Pugh grade C); 3. Patients with central nervous system diseases, mental system diseases (schizophrenia, mania, insanity, etc.), long-term use of sedatives, craniocerebral injury and/or cerebrovascular accident history, possible intracranial hypertension, cerebral aneurysm, glaucoma, etc; 4. Patients with poorly controlled or untreated hypertension (resting systolic blood pressure greater than 180 mmHg or resting diastolic blood pressure greater than 100 mmHg), heart failure (NYHA class III-IV), unstable angina pectoris, and prolonged QT interval on ECG: Men with QT interval ?450ms, women with QT interval?470ms, third degree atrioventricular block and other severe arrhythmias, severe heart valve disease (such as moderate or more valve insufficiency or stenosis, or multiple valve disease); 5. Long-term preoperative use of analgesics, non-steroidal drugs, and allergic or contraindicated to esketamine, opioids, propofol, haloperidol and other drugs and their drug components; 6. Patients transferred to ICU after operation; 7. Patients who are unwilling to use PCIA or refuse to participate in this study; 8. Other conditions deemed unsuitable for inclusion by the investigator.

Design outcomes

Primary

MeasureTime frame
Opioid dose at 48 hours after operation;

Secondary

MeasureTime frame
Pain scores at 2 hours, 6 hours, 1 day, 2 days, 7 days, 1 month, 3 months, 6 months, and 12 months after operation;GAP-7/PHQ-9 scores and sleeping scores at 1 day, 2 days, 1 day, 2 days, 7 days, 1 month, 3 months, 6 months and 12 months after surgery;Health status score at 7 days, 1 month, 3 months, 6 months and 12 months after operation;Agitation and sedation were evaluated at 2 hours, 6 hours, 1 day, and 2 days after operation;Incidence of adverse reactions (nausea, vomiting, dizziness);Time of first postoperative anal exhaust;

Countries

China

Contacts

Public ContactLiaojuan

The Third Xiangya Hospital of Central South University

807993248@qq.com0731-88618152

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026