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Clinical Trials/NCT06300944
NCT06300944
Completed
Not Applicable

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

General Hospital of Ningxia Medical University1 site in 1 country100 target enrollmentDecember 1, 2023

Overview

Phase
Not Applicable
Intervention
saline
Conditions
Postoperative Pain
Sponsor
General Hospital of Ningxia Medical University
Enrollment
100
Locations
1
Primary Endpoint
Moderate to severe pain
Status
Completed
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
December 1, 2023
End Date
December 1, 2024
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Sponsor
General Hospital of Ningxia Medical University
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Patient Undergoing laparoscopic uterine surgery under general anesthesia (total hysterectomy, myomectomy);
  • Patients gave the informed consent and signed the informed consent form.
  • The ASA is Ⅰ-Ⅱ

Exclusion Criteria

  • Patients allergic to anesthetics, ropivacaine, and esketamine or with contraindications to use;
  • Patients with cognitive dysfunction or an inability to communicate;
  • Transfer to the ICU after surgery;
  • Patients with hyperthyroidism, tachyarrhythmia, or severe hypertension;
  • Unwilling to use PCIA or refuse to participate in this trial;
  • Patients with liver and kidney dysfunction

Arms & Interventions

Group C(Control Group)

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

Intervention: saline

Group K(Esketamine Group)

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.

Intervention: Esketamine

Outcomes

Primary Outcomes

Moderate to severe pain

Time Frame: 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

Time Frame: 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

Time Frame: 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 Outcomes

  • Remifentanil dosage(During surgery)
  • Additional post-operative analgesics(Within 48 hours after surgery)
  • Postoperative exhaust time of patients(Within three days after surgery)

Study Sites (1)

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