Optic IconOptic Logo
|
SearchCollectionsBenchmarks
Clinical trial

The Effect of Low-dose Ketamine on Postoperative Pain Relief and Sleep Quality in Patients Undergoing Laparoscopic Uterine Surgery

ID
Name
Ran Gao-2023-12
Description
The purpose of this study is to investigate whether continuous intraoperative infusion of esketamine combined with the addition of esketamine to postoperative PCIA can improve postoperative pain and sleep quality in patients undergoing laparoscopic uterine surgery under general anesthesia.
Trial arms
Trial start
2023-12-01
Estimated PCD
2024-10-01
Trial end
2024-10-01
Status
Recruiting
Treatment
saline
A maintenance dose of saline is 0.2mg/kg/h and postoperative PCIA regimen was Sufentanil 2ug/kg, ondansetron 16mg, diluted with appropriate normal saline, a total of 100ml
Arms:
Group C(Control Group)
Other names:
placebo
Esketamine
A maintenance dose of esketamine is 0.2mg/kg/h and postoperative PCIA regimen was Sufentanil 2ug/kg, ondanseetron 16mg, esketamine 0.75mg/kg, diluted with appropriate normal saline, a total of 100ml
Arms:
Group K(Esketamine Group)
Other names:
analgesic
Size
108
Primary endpoint
Moderate to severe pain
2 hours, 4 hours, 8 hours, 12 hours, 24 hours after surgery
Incidence of adverse reactions including nausea, vomiting and dizziness
Within 48 hours after surgery
Sleep quality
the first and second night after surgery
Eligibility criteria
Inclusion Criteria: 1. Patient Undergoing laparoscopic uterine surgery under general anesthesia (total hysterectomy, myomectomy); 2. Patients gave the informed consent and signed the informed consent form. 3. The ASA is Ⅰ-Ⅱ Exclusion Criteria: 1. Patients allergic to anesthetics, ropivacaine, and esketamine or with contraindications to use; 2. Patients with cognitive dysfunction or an inability to communicate; 3. Transfer to the ICU after surgery; 4. Patients with hyperthyroidism, tachyarrhythmia, or severe hypertension; 5. Unwilling to use PCIA or refuse to participate in this trial; 6. Patients with liver and kidney dysfunction
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'parallel assignment', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 108, 'type': 'ESTIMATED'}}
Updated at
2024-03-08

1 organization

2 products

1 indication

Organization
General Hospital of Ningxia Medical University
Product
saline
Indication
Postoperative Pain
Product
Esketamine