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

General Hospital of Ningxia Medical University100 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

100

Conditions

Postoperative Pain

Interventions

salineDRUG

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

EsketamineDRUG

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

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (1)

General Hospital of Ningxia Medical University

Yinchuan, Ningxia, China

Outcomes

Primary Outcomes

Moderate to severe pain

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

Time frame: 2 hours, 4 hours, 8 hours, 12 hours, 24 hours after surgery

Incidence of adverse reactions including nausea, vomiting and dizziness

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.

Time frame: Within 48 hours after surgery

Sleep quality

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.

Time frame: the first and second night after surgery

Secondary Outcomes

Remifentanil dosage

The total amount of remifentanil used during surgery

Time frame: During surgery

Additional post-operative analgesics

The total amount of additional analgesics used after surgery (oral versus intramuscular)

Data from ClinicalTrials.gov

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