The Effect of Esketamine on Postoperative Pain Relief in Patients Undergoing Laparoscopic Surgery

General Hospital of Ningxia Medical University

Status: Completed

Conditions: Postoperative Pain

Treatments: Drug: Esketamine; Drug: saline

Study type: Interventional

Funder types: Other

Identifiers

NCT06300944

Ran Gao-2023-12

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 patients

Sex: Female

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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100 participants in 2 patient groups

Group C(Control Group)

Active Comparator group

Description:

At the beginning of the operation, intravenous infusion of reifentanil 0.1\~0.2 μg/kg·min, propofol 2\~4mg/kg·h, rocuronium 0.3mg/kg·h intermittently, inhalation of 1%\~2% sevoflurane were maintained, the fluctuation of blood pressure was not more than 20% of the basic level, and the heart rate was 50\~100 times /min. Pump proper amount of normal saline.The postoperative PCIA regimen was Sufentanil 2ug/kg, ondansetron 16mg, diluted with appropriate normal saline, a total of 100ml

Treatment:

Drug: saline

Group K(Esketamine Group)

Experimental group

Description:

Intraoperatively, remifentanil 0.1-0.2 μg/kg·min, propofol 2-4 mg/kg·h, intermittent rocuronium 0.3 mg/kg·h, inhalation of 1%-2% sevoflurane were given by continuous intravenous infusion, to maintain blood pressure fluctuation within 20% of the baseline level and heart rate within 50-100 beats/min. Esketamine 0.2mg/kg·h was pumped at the beginning of the procedure.The postoperative PCIA regimen was Sufentanil 2ug/kg, ondanseetron 16mg, esketamine 0.75mg/kg, diluted with appropriate normal saline, a total of 100ml.

Treatment:

Drug: Esketamine