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Efficacy and safety of opioid-free anesthesia with esketamine in laparoscopic cholecystectomy: a single-center, randomized, controlled, noninferiority clinical study

Efficacy and safety of opioid-free anesthesia with esketamine in laparoscopic cholecystectomy: a single-center, randomized, controlled, noninferiority clinical study

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400083312
Enrollment
Unknown
Registered
2024-04-22
Start date
2024-04-22
Completion date
Unknown
Last updated
2024-04-29

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

Conditions

Laparoscopic cholecystectomy

Interventions

Opioid-Free Group :Esketamine was used for analgesia.
Opioid-Based Group :Sufentanil and remifentanil were used for analgesia.

Sponsors

The First Affiliated Hospital of Nanjing Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: (1) 18 to 65 years old; (2) ASA physical status I-II; (3) undergoing elective laparoscopic cholecystectomy; (4) willing to sign informed consent.

Exclusion criteria

Exclusion criteria: (1) allergy to related medication; (2) a history of surgery within the past 1 month; (3) patients with nervous system diseases or mental disorders; (4) unable to understand the Digital Rating Scale (NRS); (5) patients with untreated or poorly controlled hypertension (arterial hypertension, resting systolic/diastolic blood pressure > 180/100 mmHg); (6) patients with untreated or undertreated hyperthyroidism; (7) patients with unstable angina or myocardial infarction in the past 6 months; (8) high intraocular pressure (glaucoma) and penetrating ocular trauma, the intraocular pressure can not be increased.

Design outcomes

Primary

MeasureTime frame
Numerical rating scale;

Secondary

MeasureTime frame
Perioperative blood pressure;Perioperative heart rate;Duration of surgery;Duration of extubation;Dosage of vasoactive agents;Postoperative nausea and vomiting;Postoperative delirium;Postoperative hypoxemia;The time of first request for analgesic after surgery;The first postoperative analgesic dosage was requested;Length of postoperative hospital stay;

Countries

China

Contacts

Public ContactZhou, Ling

The First Affiliated Hospital of Nanjing Medical University

lingzhou531@foxmail.com+86 158 9591 8786

Outcome results

None listed

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