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

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

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.

Study Overview

• Status: Completed
• Conditions: Postoperative Pain
• Intervention / Treatment: Drug: saline; Drug: Esketamine

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.

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Ningxia
    • Yinchuan, Ningxia, China
      • General Hospital of Ningxia Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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	Drug: saline; 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; Other Names: placebo
Experimental: 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.	Drug: Esketamine; 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; Other Names: analgesic

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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.	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.	the first and second night after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Remifentanil dosage	The total amount of remifentanil used during surgery	During surgery
Additional post-operative analgesics	The total amount of additional analgesics used after surgery (oral versus intramuscular)	Within 48 hours after surgery
Postoperative exhaust time of patients	How long does the patient recover bowel motility after surgery	Within three days after surgery

Collaborators and Investigators

• Sponsor: General Hospital of Ningxia Medical University

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2023
• Primary Completion (Actual): October 1, 2024
• Study Completion (Actual): December 1, 2024

Study Registration Dates

• First Submitted: February 23, 2024
• First Submitted That Met QC Criteria: March 7, 2024
• First Posted (Actual): March 8, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 6, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: Esketamine; Laparoscopic uterine surgery; postoperative pain and sleep quality
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Postoperative Complications; Pathologic Processes; Pain, Postoperative; Physiological Effects of Drugs; Peripheral Nervous System Agents; Sensory System Agents; Psychotropic Drugs; Antidepressive Agents; Esketamine; Analgesics
• Other Study ID Numbers: Ran Gao-2023-12

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No