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

Postoperative Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06300944
• Other study ID #: Ran Gao-2023-12
• Status: Recruiting
• Phase: N/A
• Start date: December 1, 2023
• Est. completion date: October 1, 2024

Study information

• Verified date: March 2024
• Source: General Hospital of Ningxia Medical University
• Contact: Ma Hanxiang
• Phone: 86-13519591508
• Email: mahanxiang[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 108
• Est. completion date: October 1, 2024
• Est. primary completion date: October 1, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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 ?-?

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

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain

Intervention

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
• 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

Locations

Country	Name	City	State
China	General Hospital of Ningxia Medical University	Yinchuan	Ningxia

Sponsors (1)

Lead Sponsor	Collaborator
General Hospital of Ningxia Medical University

Country where clinical trial is conducted

China, 

Outcome

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