Postoperative PainNCT06300944
The Effect of Esketamine on Postoperative Pain Relief in Patients Undergoing Laparoscopic Surgery
A study testing saline and Esketamine in people with Postoperative Pain, run by General Hospital of Ningxia Medical University at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- saline and Esketamine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2023to 1 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Postoperative Pain
- Being tested
- saline, Esketamine
- Keywords
- Esketamine, Laparoscopic uterine surgery, postoperative pain and sleep quality
- Medical subject headings
- Pain, Postoperative, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
salineDrug
Also called placebo
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
EsketamineDrug
Also called analgesic
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: Drug: Esketamine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 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.
Measured: the first and second night after surgery
Secondary outcomes (3)
Remifentanil dosage
The total amount of remifentanil used during surgery
Measured: During surgery
Additional post-operative analgesics
The total amount of additional analgesics used after surgery (oral versus intramuscular)
Measured: Within 48 hours after surgery
Postoperative exhaust time of patients
How long does the patient recover bowel motility after surgery
Measured: Within three days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2024
- Study start1 Dec 2023
- Primary completion1 Oct 2024
- Study completion1 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- parallel assignment
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- General Hospital of Ningxia Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06300944
- Sponsor's protocol ID
- Ran Gao-2023-12
- Status last verified
- Feb 2025
- First submitted
- 23 Feb 2024
- Last updated
- 7 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Low-dose Ketamine on Postoperative Pain Relief and Sleep Quality in Patients Undergoing Laparoscopic Uterine Surgery
- ClinicalTrials.gov ID
- NCT06300944
- Acronym / sponsor ID
- Ran Gao-2023-12
- Conditions
- Postoperative Pain
- Keywords
- Esketamine, Laparoscopic uterine surgery, postoperative pain and sleep quality
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- General Hospital of Ningxia Medical UniversityUniversity, hospital or other
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- 1 Oct 2024 (actual)
- Study completion
- 1 Dec 2024 (actual)
- First posted
- 8 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- parallel assignment
| Arm | Type | Receives |
|---|---|---|
| Group C(Control Group) | Active comparator | Drug: salineAt 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 | Drug: EsketamineIntraoperatively, 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| salineAlso: placeboA 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 | Drug | Group C(Control Group) |
| EsketamineAlso: analgesicA 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 | Drug | Group K(Esketamine Group) |
Primary outcome
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.
3 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing saline and Esketamine in people with Postoperative Pain, run by General Hospital of Ningxia Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Moderate to severe pain (time frame: 2 hours, 4 hours, 8 hours, 12 hours, 24 hours after surgery). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2025.