Study on the Effective Dose and Safety of Esketamine in Hysteroscopic Surgery Under Monitored Ane… (NCT07034963) | Clinical Trial Compass
Active — Not RecruitingPhase 1/2
Study on the Effective Dose and Safety of Esketamine in Hysteroscopic Surgery Under Monitored Anesthesia Care
China95 participantsStarted 2025-06-26
Plain-language 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. 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.
Who can participate
Age range
18 Years – 55 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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.
Exclusion Criteria:
(i) 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.
(ii) Comorbidities:
* 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).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Cervical dilation-induced somatic responses
Timeframe: Day 1 (During the surgery at the first stage of the research)
2
Incidence of respiratory depression
Timeframe: Day 1 (T2-T6 of the second stage of the research)
Trial details
NCT IDNCT07034963
SponsorThe First Affiliated Hospital of Xiamen University