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

NCT06300944 | Completed DMC

• 1 other identifier: Ran Gao-2023-12
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Pain

Keywords

Esketamine; Laparoscopic uterine surgery; postoperative pain and sleep quality

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (3)

• Remifentanil dosage

  During surgery

• Additional post-operative analgesics

  Within 48 hours after surgery

• Postoperative exhaust time of patients

  Within three days after surgery

Study Arms (2)

Group C(Control Group)

ACTIVE COMPARATOR

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

Group K(Esketamine Group)

EXPERIMENTAL

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

Interventions

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

Also known as: placebo

Group C(Control Group)

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

Also known as: analgesic

Group K(Esketamine Group)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• General Hospital of Ningxia Medical University: lead

Study Sites (1)

General Hospital of Ningxia Medical University

Yinchuan, Ningxia, China

Location

MeSH Terms

Conditions

Pain, Postoperative; Sleep Initiation and Maintenance Disorders

Interventions

Sodium Chloride; Esketamine; Analgesics

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds; Sensory System Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Central Nervous System Agents; Therapeutic Uses

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: parallel assignment

Study Record Dates

• First Submitted: February 23, 2024
• First Posted: March 8, 2024
• Study Start: December 1, 2023
• Primary Completion: October 1, 2024
• Study Completion: December 1, 2024
• Last Updated: February 7, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)