Skip to main content
OpenTrials
Completed

NCT Number: NCT06300944

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Postoperative Pain Dyssomnias Mental Disorders Nervous System Diseases Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

18 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

General Hospital of Ningxia Medical University

Yinchuan, Ningxia, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Saline

Drug

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

Esketamine

Drug

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

Primary outcomes

  1. 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

  2. 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.

  3. 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

  1. Remifentanil dosage

    Time frame: During surgery

    The total amount of remifentanil used during surgery

  2. Additional post-operative analgesics

    Time frame: Within 48 hours after surgery

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

  3. Postoperative exhaust time of patients

    Time frame: Within three days after surgery

    How long does the patient recover bowel motility after surgery

Sponsors and collaborators

Lead sponsor

General Hospital of Ningxia Medical University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Mar 8, 2024
Registry last updated
Feb 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.