Postoperative Pain
Conditions
Keywords
Esketamine, Laparoscopic uterine surgery, postoperative pain and sleep quality
Brief summary
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.
Detailed description
Esketamine is the right isomer of ketamine, which is better than the original ketamine and has fewer side effects. In addition, for some gynecological hysterectomy patients who have poor sleep quality and anxiety after surgery, Esketamine also has the effect of treating depression. Due to the side effects of postoperative nausea, vomiting and hyperalgesia caused by excessive dosage of some opioids, this study will continue to inject small doses of esketamine during the operation to reduce the intraoperative dosage of opioids, and add esketamine to the postoperative PCIA for analgesia. To explore whether this method can reduce the incidence of moderate and severe postoperative pain in patients with laparoscopic uterine surgery under general anesthesia.
Interventions
DRUGsaline
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
DRUGEsketamine
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
Sponsors
General Hospital of Ningxia Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Intervention model description
parallel assignment
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Moderate to severe pain | 2 hours, 4 hours, 8 hours, 12 hours, 24 hours after surgery | Pain severity was measured using The NRS((Numerical Rating Scale), The NRS\>3 was considered moderate to severe pain.The NRS score at 2 hours, 4 hours, 8 hours, 12hours, 24hours after surgery was observed to determine whether intraoperative infusion of esketamine combined with perioperative analgesia regimen of esketamine in postoperative PCIA could reduce the incidence of postoperative moderate to severe pain in patients undergoing gynecological laparoscopic uterine surgeryesketamine to postoperative PCIA can reduce the incidence of postoperative moderate to severe pain in patients undergoing laparoscopic uterine surgery under general anesthesia |
| Incidence of adverse reactions including nausea, vomiting and dizziness | Within 48 hours after surgery | Postoperative nausea, vomiting and dizziness is the subjective discomfort of dizziness, nausea, vomiting after the patient is awake, and the diagnosis can be made according to the clinical manifestations of the patient 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 | Sleep quality scores on the first and second night after surgery was assessed by AIS((Athens Insomnia Scale).The AIS\<4 was classified as no sleep disorder, AIS of 4 to 6 is classified as suspicious insomnia, AIS\>6 is classified as insomnia. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Remifentanil dosage | During surgery | The total amount of remifentanil used during surgery |
| Additional post-operative analgesics | Within 48 hours after surgery | The total amount of additional analgesics used after surgery (oral versus intramuscular) |
| Postoperative exhaust time of patients | Within three days after surgery | How long does the patient recover bowel motility after surgery |
Countries
China
Outcome results
None listed