Skip to content

A multicenter, randomized controlled clinical trial on the safety and efficacy of anesthetized dose of esmketamine in perioperative analgesia for opioid frugality

A multicenter, randomized controlled clinical trial on the safety and efficacy of anesthetized dose of esmketamine in perioperative analgesia for opioid frugality

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100046703
Enrollment
Unknown
Registered
2021-05-27
Start date
2021-07-01
Completion date
Unknown
Last updated
2022-01-10

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

Conditions

None listed

Interventions

Group 1:Propofol 2.5 mg / kg, sufentanil 0.3 ug / kg, rocuronium 0.9 mg / kg
Group 2:Propofol 2.5 mg / kg, esmketamine 0.2 mg / kg, sufentanil 0.3 ng/ kg, rocuronium 0.9 mg / kg
Group 3:Propofol 2.5 mg / kg, esmketamine 0.3 mg / kg, sufentanil 0.3 ng / kg, rocuronium 0.9 mg / kg

Sponsors

Affiliated Hospital of Zunyi Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
3 Years to 64 Years

Inclusion criteria

Inclusion criteria: 1. Aged 3-64 years, no gender limit; 2. Patients with ASA I-II general anesthesia surgery; 3. 18 kg/m^2 < BMI< 30 kg/m^2.

Exclusion criteria

Exclusion criteria: 1. Patients who have used narcotic analgesics within 24 hours or who have used anesthetics within 5 days, who have taken benzodiazepine sleeping pills and opioid analgesics for a long time (continuously or intermittently). 2. A history of severe cardiovascular disease (such as myocardial ischemia, heart failure and arrhythmia, etc.); angina pectoris (unstable angina) due to insufficient blood supply to the coronary tubes of the heart, or myocardial infarction occurred within the last 6 months. 3. Hypertensive patients whose blood pressure has not been satisfactorily controlled by antihypertensive drugs (sitting systolic blood pressure >= 160 mmHg in the screening period, and/or diastolic blood pressure >= 100 mmHg in the screening period). 4. Patients with craniocerebral injury, possible intracranial hypertension, cerebral aneurysm, cerebrovascular accident history, and history of central nervous system disease; patients with a history of increased intraocular pressure (such as glaucoma) or puncture eye injury patient. 5. There is a history of drug abuse and/or alcohol abuse in the 2 years before screening, alcohol abuse means that the average daily alcohol consumption exceeds 2 units of alcohol (1 unit = 360 mL of beer or 45 mL of 40% alcoholic liquor or 150 mL of wine). 6. Patients who are pregnant or breastfeeding. 7. Patients with a history of hyperthyroidism. 8. Patients with mental system diseases (schizophrenia, mania, bipolar disorder, confusion, etc.), drug history and cognitive dysfunction. 9. Patients who have participated in a drug clinical trial as a subject in the past 3 months; the investigator believes that it is not appropriate to participate in this trial.

Design outcomes

Primary

MeasureTime frame
Pain VAS score;Total postoperative opioid use;PCIA pump press times;Additional doses of analgesics;Ramsay sedation score;Perioperative vital signs;

Countries

China

Contacts

Public ContactZhu Zhaoqiong

Affiliated Hospital of Zunyi Medical University

1625836721@qq.com+86 13035529980

Outcome results

None listed

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