Clinical trial NCT06300944: The Effect of Esketamine on Postoperative Pain Relief in Patients Undergoing Laparoscopic Surgery
Official title: The Effect of Low-dose Ketamine on Postoperative Pain Relief and Sleep Quality in Patients Undergoing Laparoscopic Uterine Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Pain
Keywords: Esketamine
Laparoscopic uterine surgery
postoperative pain and sleep quality
Lead sponsor: General Hospital of Ningxia Medical University
Sponsor class: OTHER
First posted: 2024-03-08
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: parallel assignment
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Moderate to severe pain
timeFrame: 2 hours, 4 hours, 8 hours, 12 hours, 24 hours after surgery
measure: Incidence of adverse reactions including nausea, vomiting and dizziness
timeFrame: Within 48 hours after surgery
measure: Sleep quality
timeFrame: the first and second night after surgery
Secondary outcomes:
measure: Remifentanil dosage
timeFrame: During surgery
measure: Additional post-operative analgesics
timeFrame: Within 48 hours after surgery
measure: Postoperative exhaust time of patients
timeFrame: Within three days after surgery
Other outcomes:
Locations:
city: Yinchuan
country: China
facility: General Hospital of Ningxia Medical University
state: Ningxia
Study officials:
References: