---
title: The Effect of Esketamine on Postoperative Pain Relief in Patients Undergoing Laparoscopic Surgery
nct_id: NCT06300944
overall_status: COMPLETED
phase: NA
sponsor: General Hospital of Ningxia Medical University
study_type: INTERVENTIONAL
primary_condition: Postoperative Pain
countries: China
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT06300944.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT06300944"
ct_last_update_post_date: 2025-02-07
last_seen_at: "2026-05-12T06:35:07.814Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# The Effect of Esketamine on Postoperative Pain Relief in Patients Undergoing Laparoscopic Surgery

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

**NCT ID:** [NCT06300944](https://clinicaltrials.gov/study/NCT06300944)

## Key Facts

- **Status:** COMPLETED
- **Phase:** NA
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 100
- **Lead Sponsor:** General Hospital of Ningxia Medical University
- **Conditions:** Postoperative Pain
- **Start Date:** 2023-12-01
- **Completion Date:** 2024-12-01
- **CT.gov Last Update:** 2025-02-07

## 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.

## 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.

## Eligibility

- **Minimum age:** 18 Years
- **Maximum age:** 65 Years
- **Sex:** FEMALE
- **Healthy Volunteers:** No

```
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
```

## Arms

- **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
- **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.

## 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
- **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

## Primary Outcomes

- **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
- **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.
- **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

- **Remifentanil dosage** _(time frame: During surgery)_
- **Additional post-operative analgesics** _(time frame: Within 48 hours after surgery)_
- **Postoperative exhaust time of patients** _(time frame: Within three days after surgery)_

## Locations (1)

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

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.general hospital of ningxia medical university|yinchuan|ningxia|china` — added _(2026-05-12)_

---

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