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Effect of intraoperatively intravenous infusion of esmketamine hydrochloride on the usage of analgesics during and after laparoscopic cholecystectomy in elderly patients: a multicenter, prospective, randomized, double-blind, controlled study

Effect of intraoperatively intravenous infusion of esmketamine hydrochloride on the usage of analgesics during and after laparoscopic cholecystectomy in elderly patients: a multicenter, prospective, randomized, double-blind, controlled study

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100041862
Enrollment
Unknown
Registered
2021-01-08
Start date
2021-03-01
Completion date
Unknown
Last updated
2021-03-30

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

Conditions

Acute pain

Interventions

Control group:Normal saline
Experiment group:Esmketamine hydrochloride

Sponsors

Shanghai East Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
65 Years to 100 Years

Inclusion criteria

Inclusion criteria: 1) Aged over 65 years old and the gender is not limited; 2) Body mass index (BMI) between 18.5 ~ 25 kg / m2, ASA I ~ III grade; 3) Patients undergoing laparoscopic cholecystectomy and operation time last about 1 hour; 4) Hospital stay more than 48 hours.

Exclusion criteria

Exclusion criteria: 1) Patients with mental history or with antipsychotic drugs; 2) Patients with abuse of narcotic analgesics or sedatives, such as ketamine, patients with alcohol abuse; 3) Patients who are allergic to propofol, opioids, esmketamine and other narcotic drugs or have contraindications; 4) Patients with vision loss or intraocular pressure can not be increased; 5) Patients using drugs (such as aminophylline or theophylline) that affect the evaluation of efficacy and safety were used; 6) Patients using drugs that affect the liver and kidney metabolism of esmketamine, such as liver enzyme inhibitor chlorpromazine, etc; 7) Patients with severe decompensation of liver and kidney function; 8) Patients with severe risk of elevated blood pressure or intracranial pressure, poorly controlled or untreated hypertension (arterial hypertension, resting systolic / diastolic blood pressure more than 180 / 100mmhg); 9) Patients with hyperthyroidism; 10) Patients with unstable angina pectoris or myocardial infarction occurred in the past 6 months; previous severe angina pectoris; congestive heart failure; 11) The researchers judged that the subjects, including but not limited to the patients with important organ dysfunction and / or severe systemic diseases, were not suitable to participate in this clinical study.

Design outcomes

Primary

MeasureTime frame
Dosage of analgesics;

Secondary

MeasureTime frame
visual analogue scale;

Countries

China

Contacts

Public ContactXiangrui Wang

Shanghai East Hospital

xruiwang@vip.sina.com+86 13701901953

Outcome results

None listed

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