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Intrauterine PolypPhase 1/2NCT07034963

Study on the Effective Dose and Safety of Esketamine in Hysteroscopic Surgery Under Monitored Anesthesia Care

A Phase 1/2 study testing Determine the ED50 and ED95 of esketamine, Intravenous the dose of esketamine ED95 and Intravenous remifentanil 1μg∙kg-1 in people with Intrauterine Polyp and Intrauterine Synechiae, run by The First Affiliated Hospital of Xiamen University at 1 site in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

Cervical dilation-induced somatic responses remain a critical challenge in ambulatory hysteroscopic surgery. Esketamine, an N-methyl-D-aspartate (NMDA) receptor antagonist, exhibits unique analgesic and sedative properties that may enhance perioperative somatic response inhibition. Read more about this study

Who is it for?
Ages 18 to 55 years, women only
Conditions the study is for
Intrauterine Polyp, Intrauterine Synechiae
What is being tested?
Determine the ED50 and ED95 of esketamine, Intravenous the dose of esketamine ED95 and Intravenous remifentanil 1μg∙kg-1
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
95 participants
Where
1 siteChina
Study dates
26 Jun 2025to 30 Jun 2028
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

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 55 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • Aged 18 - 55 years;
  • ASA physical status Ⅰ or Ⅱ;
  • Body mass index (BMI) 18 - 28 kg∙m-2;
  • Scheduled for elective diagnostic/therapeutic hysteroscopy.

Who cannot join

  • Pharmacological contraindications:
  • Known hypersensitivity to study medications (esketamine, remifentanil, dexmedetomidine);
  • Opioid or benzodiazepine medications dependence;
  • Analgesic/psychotropic medication use within 48 hours preoperatively;
  • Participation in any other drug clinical trial within the preceding three months.
  • Comorbidities:
Show all 13Show fewer
  • Significant cardiopulmonary dysfunction (NYHA III-IV, FEV₁/FVC <70%);
  • Hepatic impairment (Child-Pugh B/C);
  • Uncontrolled hypertension, intracranial hypertension, intraocular hypertension or hyperthyroidism;
  • Neurological/psychiatric conditions (epilepsy, schizophrenia, depression);
  • Active gastroesophageal reflux disease (GERD-Q score ≥8). (iii) Airway/Perioperative Risks:
  • Anticipated difficult airway (Mallampati III-IV, thyromental distance <6 cm) or airway stenosis;
  • Non-fasted status (solids <8h, clear fluids <2h preoperatively).

Trial locations and contacts

1 site in 1 country.

China1 site

  • Department of Anesthesiology, The First Affiliated Hospital of Xiamen University, 55 Zhenhai Road, Xiamen, China

    Xiamen, Fujian, 361000

Other trials in China

About this study

Cervical dilation-induced somatic responses remain a critical challenge in ambulatory hysteroscopic surgery. Esketamine, an N-methyl-D-aspartate (NMDA) receptor antagonist, exhibits unique analgesic and sedative properties that may enhance perioperative somatic response inhibition. However, the effective dose of esketamine under dexmedetomidine-remifentanil based monitored anesthesia care (MAC) during ambulatory hysteroscopic surgery remains to be determined. This prospective dose-finding study aimed to establish the median effective dose (ED50) and 95% effective dose (ED95) of esketamine for cervical response suppression. Afterwards, the investigators will conduct an RCT study to evaluate the safety of the dose of esketamine ED95 through the incidence of respiratory depression.

Read the detailed description

This research will be divided into two stages. (i) In Phase one, a prospective dose discovery study using the Dixon sequential method will be conducted, aiming to determine the median effective dose (ED50) and 95% effective dose (ED95) of esketamine in inhibiting cervical response. Esketamine will be initiated by intravenous infusion at 0.3 mg∙kg-1, followed by somatic response based on cervical dilation (positive: any exercise; negative: no movement). Dose adjustment will be carried out, with a dose fluctuation step of 0.02 mg∙kg-1 up and down. All patients will receive a standardized anesthesia regimen, including continuous infusion of remifentanil at a dose of 5 μg∙kg∙h-1, combined with dexmedetomidine (infusion at a loading dose of 0.6 μg∙kg-1 for 10 minutes, followed by maintenance infusion at 0.4 μg∙kg-1∙h-1). The test will continue until six cross-pairings are obtained. Probabilistic regression analysis will be used to calculate the ED50 and ED95 of esketamine with a 95% confidence interval.

(ii) The investigators will conduct a single-center, randomized, double-blind controlled trial in Phase Two to evaluate the safety of the esketamine ED95 dose under the monitoring anesthesia care program based on the incidence of respiratory depression. The intervention group will be injected with the dose of esketamine ED95; the control group will be injected with remifentanil 1μg∙kg-1. Both groups of patients will receive the same sedation regimen, namely remifentanil will be continuously pumped at a rate of 5μg∙kg∙h-1 combined with dexmedetomidine (pumped at a loading dose of 0.6 μg∙kg-1 for 10 minutes, followed by maintenance pumping at 0.4 μg∙kg-1∙h-1). Intravenous injection of 100 mg of flurbiprofen axetil for auxiliary analgesia. Intravenous injection of 4 mg of ondansetron to prevent nausea and vomiting.

Being tested
Determine the ED50 and ED95 of esketamine, Intravenous the dose of esketamine ED95, Intravenous remifentanil 1μg∙kg-1
Keywords
ambulatory hysteroscopic surgery, monitored anesthesia care, esketamine, cervical dilation response, Intrauterine lesion
Medical subject headings
Gynatresia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Determine the ED50 and ED95 of esketamineDrug

    Also called Remifentanil will be continuously pumped at a rate of 5μg∙kg∙h-1 combined with dexmedetomidine (a loading dose of 0.6 μg∙kg-1 for 10 minutes, followed by maintenance dose of 0.4 μg∙kg-1∙h-1).

    According to Dixon's up-and-down sequential design, esketamine will be initiated at 0.3 mg∙kg-1 intravenously, followed by dose adjustments (0.02 mg∙kg-1 increments/decrements) based on somatic responses to cervical dilation (positive: any movement; negative: no movement). The tests will continued until six crossover pairs are achieved.

  • Intravenous the dose of esketamine ED95Drug

    Also called Remifentanil will be continuously pumped at a rate of 5μg∙kg∙h-1 combined with dexmedetomidine (a loading dose of 0.6 μg∙kg-1 for 10 minutes, followed by maintenance dose of 0.4 μg∙kg-1∙h-1).

    The intervention group will be injected with the dose of esketamine ED95.

  • Intravenous remifentanil 1μg∙kg-1Drug

    Also called Remifentanil will be continuously pumped at a rate of 5μg∙kg∙h-1 combined with dexmedetomidine (a loading dose of 0.6 μg∙kg-1 for 10 minutes, followed by maintenance dose of 0.4 μg∙kg-1∙h-1).

    The control group will be injected with remifentanil 1μg∙kg-1.

Study groups in NCT07034963
Study groupRoleWhat they receive
Determine the ED50 and ED95 of esketamine by Dixon's up-and-down methodExperimentalAccording to Dixon's up-and-down sequential design, esketamine will be initiated at 0.3 mg∙kg-1 intravenously, followed by dose adjustments (0.02 mg∙kg-1 increments/decrements) based on somatic responses to cervical dilation (positive: any movement; negative: no movement). The tests will continue until six crossover pairs are achieved.
Receives: Drug: Determine the ED50 and ED95 of esketamine
Evaluate the safety of the dose of esketamine ED95 by the incidence of respiratory depressionActive comparatorThe intervention group will be injected with the dose of esketamine ED95; the control group will be injected with remifentanil 1μg∙kg-1. Both groups of patients will receive the same Monitoring Anesthesia Care (MAC) regimen, namely, remifentanil will be continuously pumped at a rate of 5μg∙kg∙h-1 combined with dexmedetomidine (a loading dose of 0.6 μg∙kg-1 for 10 minutes, followed by maintenance dose of 0.4 μg∙kg-1∙h-1). Intravenous injection of 100 mg of flurbiprofen axetil for auxiliary analgesia. Intravenous injection of 4 mg of ondansetron to prevent nausea and vomiting. The study at this stage will evaluate the safety of the dose of esketamine ED95 through the incidence of respiratory depression.
Receives: Drug: Intravenous the dose of esketamine ED95; Drug: Intravenous remifentanil 1μg∙kg-1

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Cervical dilation-induced somatic responses

    Positive: Body movement or complaint of pain. Negative: No body movement or no reported pain. This scale will be administered during the surgery at the first stage of the research.

    Measured: Day 1 (During the surgery at the first stage of the research)

  2. Incidence of respiratory depression

    The primary outcome is the incidence of respiratory depression, which is defined as SpO2 <90% or EtCO2 >55 mmHg.

    By comparing with the control group, evaluate the safety of ED95 of esketamine by the incidence of respiratory depression at T2-T6 of the second stage of the research.

    T2: 60 seconds after esketamine injection; T3: During vaginal disinfection; T4: During cervical dilation; T5: During intrauterine operations; T6: In the PACU.

    Measured: Day 1 (T2-T6 of the second stage of the research)

Secondary outcomes (15)

  1. HR

    HR: heart rate. T1: Prior to anesthesia (10 minutes after positioning); T2: 60 seconds after esketamine injection; T3: During vaginal disinfection; T4: During cervical dilation; T5: During intrauterine operations; T6: In the PACU.

    Measured: Day 1 (T1-T6 of the first and second stages of the research)

  2. MAP

    MAP: Mean Arterial Pressure. T1: Prior to anesthesia (10 minutes after positioning); T2: 60 seconds after esketamine injection; T3: During vaginal disinfection; T4: During cervical dilation; T5: During intrauterine operations; T6: In the PACU.

    Measured: Day 1 (T1-T6 of the first and second stages of the research)

  3. RR

    RR: respiratory rate. T1: Prior to anesthesia (10 minutes after positioning); T2: 60 seconds after esketamine injection; T3: During vaginal disinfection; T4: During cervical dilation; T5: During intrauterine operations; T6: In the PACU.

    Measured: Day 1 (T1-T6 of the first and second stages of the research)

  4. SPO2

    SPO2: peripheral oxygen saturation. T1: Prior to anesthesia (10 minutes after positioning); T2: 60 seconds after esketamine injection; T3: During vaginal disinfection; T4: During cervical dilation; T5: During intrauterine operations; T6: In the PACU.

    Measured: Day 1 (T1-T6 of the first and second stages of the research)

  5. EtCO2

    EtCO2: End-expiratory carbon dioxide. SPO2: peripheral oxygen saturation. T2: 60 seconds after esketamine injection; T3: During vaginal disinfection; T4: During cervical dilation; T5: During intrauterine operations; T6: In the PACU.

    Measured: Day 1 (T2-T6 of the first and second stages of the research)

  6. Adverse events

    Adverse events will encompass a range of systems, including the cardiovascular system (eg. high/low blood pressure and sinus tachycardia/bradycardia), as well as symptoms such as nausea, vomiting, dizziness, and mental symptoms.

    T2: 60 seconds after esketamine injection; T3: During vaginal disinfection; T4: During cervical dilation; T5: During intrauterine operations; T6: In the PACU. T7 to T9: 2, 6, and 24 hours after the procedure.

    Measured: Day 1 (T2-T9 of the first and second stages of the research)

  7. NRS

    The Numeric Rating Scale (NRS) will be utilized to assess postoperative pain, with a range of 0 representing no pain and 10 representing severe pain. This scale will be administered at 2, 6, and 24 hours following the procedure.

    T7 to T9: 2, 6, and 24 hours after the procedure.

    Measured: Day 1 (T7-T9 of the first and second stages of the research)

  8. The need for remedial analgesia

    The consumption of remedial analgesia will be the total consumption of acetaminophen documented at 2, 6, and 24 hours after the procedure.

    T7 to T9: 2, 6, and 24 hours after the procedure.

    Measured: Day 1 (T7-T9 of the first and second stages of the research)

  9. Induction duration

    Induction duration is defined as the period from the start of anaesthetic drug injection to the commencement of the surgical procedure at the first and second stages of the research.

    Measured: Day 1 of the first and second stages of the research

  10. Duration of awakening

    Duration of awakening is defined as the period from the conclusion of the surgical procedure to the moment of eye-opening.

    Measured: Day 1 of the first and second stages of the research

  11. PACU time

    The time from patient admission to the PACU until the fulfillment of the criteria for PACU discharge.

    Measured: Day 1 of the first and second stages of the research

  12. Discharge time

    The interval between patient admission to the operating room and the fulfillment of the criteria for hospital discharge.

    Measured: Day 1 of the first and second stages of the research

  13. Success rate of anesthesia

    Anesthesia success will be defined as inadequate analgesia requiring ≤3 rescue doses of remifentanil within 10 min throughout the procedure. The success rate of anesthesia will be calculated by dividing the number of successful anesthesia cases by the total number of cases.

    T2: 60 seconds after esketamine injection; T3: During vaginal disinfection; T4: During cervical dilation; T5: During intrauterine operations.

    Measured: Day 1 (T2-T5 of the second stage of the research)

  14. The satisfaction of gynecologists

    The satisfaction score of gynecologists will be collected postoperatively on Day 1, using a scale ranging from 0 to 10, with 0 representing dissatisfaction and 10 representing very satisfied.

    Measured: Day 1 of the second stage of the research

  15. The satisfaction of patients

    The satisfaction of patients will be collected postoperatively on Day 2, using a scale ranging from 0 to 10, with 0 representing dissatisfaction and 10 representing very satisfied.

    Measured: Day 2 of the second stage of the research

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Jun 2025
  2. Study start26 Jun 2025
  3. Primary completion30 Jun 2028 (estimated)
  4. Study completion30 Jun 2028 (estimated)

Resources

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 1/2
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Sequential
Model description
This research will be divided into two stages. (i) In Phase one, a prospective dose discovery study using the Dixon sequential method will be conducted, aiming to determine the median effective dose (ED50) and 95% effective dose (ED95) of esketamine in inhibiting cervical response. The test will continue until six cross-pairings are obtained. The sample size is approximately 33. (ii) The investigators will conduct a single-center, randomized, double-blind controlled trial in Phase Two to evaluate the safety of the esketamine ED95 dose under the monitoring anesthesia care program based on the incidence of respiratory depression. The intervention group will be injected with the dose of esketamine ED95; the control group will be injected with remifentanil 1μg∙kg-1. Both groups of patients will receive the same sedation regimen. The sample size is approximately 62.
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
95 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07034963
Sponsor's protocol ID
XMFHIIT-2025SL092
Status last verified
Jun 2025
First submitted
29 May 2025
Last updated
24 Jul 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Yan L, Wang X, Wei J, Zhang M, Yang B. Prospective Dose-Finding of Esketamine for Suppressing Cervical Dilation Response in Ambulatory Hysteroscopy Under Monitored Anesthesia Care. Drug Des Devel Ther. 2025 Dec 7;19:10835-10845. doi: 10.2147/DDDT.S557340. eCollection 2025.

    PubMed 41393327

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Determine the ED50 and ED95 of esketamine, Intravenous the dose of esketamine ED95 and Intravenous remifentanil 1μg∙kg-1 in people with Intrauterine Polyp and Intrauterine Synechiae, run by The First Affiliated Hospital of Xiamen 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 4 inclusion and 13 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: under way, not looking for participants, as of the sponsor's last update on 24 Jul 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.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

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?

Cervical dilation-induced somatic responses (time frame: Day 1 (During the surgery at the first stage of the research)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07034963, which also lists 1 linked publication.

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 24 Jul 2025.

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