Urological SurgeryNCT07096115
ED90 of Teglidine for Suppressing LMA Insertion Response in the Elderly
A study testing Taiglididine in people with Urological Surgery, run by The First People's Hospital of Lianyungang.
Trial summary
This research protocol aims to investigate the 90% effective dose (ED90) of taiglididine for inhibiting laryngeal mask insertion response in elderly patients. It is a non-randomized controlled trial using a biased coin design up-down method (BCD-UDM). Read more about this study
- Who is it for?
- Ages 65 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Urological Surgery
- What is being tested?
- Taiglididine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2025to 30 Jun 2027
- Phase
- Interventional
- 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 65 to 80 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Aged 65-80 years old.
- ASA physical status I-III.
- BMI 18-30 kg/m² (inclusive of critical values).
- Mallampati class I or II, mouth opening >2.5 cm.
- No abnormal airway or head/neck conditions.
- No risk of reflux or aspiration (e.g., full stomach, obesity, gastrointestinal obstruction).
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- Expected surgery duration <180 min.
- Scheduled for urological surgery requiring general anesthesia and laryngeal mask insertion.
- Voluntary participation with signed informed consent.
Who cannot join
- Baseline measurements: Severe hypertension (SBP >160 mmHg or DBP >100 mmHg), heart rate <60 bpm or >100 bpm.
- 2. History of long-term alcohol, sedative, or analgesic use; allergy to any study drugs.
- 3. Severe dysfunction of vital organs (heart, lung, liver, kidney, nervous system), neuromuscular diseases, hyperthyroidism, obstructive sleep apnea syndrome.
- 4. History of mental disorders or cognitive impairment severe enough to hinder understanding or cooperation with the study.
- 5. Preoperative administration of sedative-hypnotics (including benzodiazepines and barbiturates).
- 6. Upper respiratory tract infection within 1 month before surgery. 7. Participation in other clinical studies within the past 3 months. 8. Other conditions deemed unsuitable for the trial by the investigator.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: The 90% Effective Dose of Taiglididine for Inhibiting Laryngeal Mask Insertion Response in Elderly Patients
This research protocol aims to investigate the 90% effective dose (ED90) of taiglididine for inhibiting laryngeal mask insertion response in elderly patients. It is a non-randomized controlled trial using a biased coin design up-down method (BCD-UDM). A total of 54 elderly patients aged 65-80 years with ASA I-III, BMI 18-30 kg/m², and suitable for urological surgery under general anesthesia with laryngeal mask insertion will be enrolled. The first patient receives an intravenous injection of 1 mg taiglididine, followed by propofol and rocuronium. Subsequent doses of taiglididine are adjusted dynamically based on the previous patient's response: increasing by 0.1 mg if the insertion response is positive, or using BCD-UDM (11% probability to decrease by 0.1 mg, 89% to remain) if negative. The primary efficacy endpoint is the occurrence of laryngeal mask insertion response, while secondary endpoints include adverse events, vital sign changes, insertion success rate, and various time intervals. Safety is evaluated by monitoring vital signs. Statistical analysis will use SPSS 25.0 and R software to calculate ED90 and 95% confidence intervals via probit regression and bootstrap method, with at least 45 valid patients required to complete the trial.
- Conditions
- Urological Surgery
- Being tested
- Taiglididine
- Keywords
- Taiglididine, Elderly Patients
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TaiglididineDrug
The first patient receives an intravenous injection of 1 mg taiglididine for anesthesia induction, followed by 1-2 mg/kg propofol. When the patient's bispectral index (BIS) drops below 60, eyelash reflex disappears, and MOAA/S score is 0, intravenous rocuronium 0.6 mg/kg is given, and a laryngeal mask is inserted by a senior anesthesiologist using a unified method 1 min later. From the second patient onward, the taiglididine dose is dynamically adjusted based on the previous patient's response to laryngeal mask insertion using BCD-UDM: if the previous patient shows a positive insertion response (positive response or MOAA/S ≥2 within 2 min after induction), the next patient's dose increases by 0.1 mg; if negative, a random number (1-95) generated by computer determines the dose: doses remain unchanged when the number is 6-95 (89% probability) and decrease by 0.1 mg when the number is 1-5 (11% probability). A collaborator not involved in result evaluation provides a sealed envelope with
| Study group | Role | What they receive |
|---|---|---|
| Taiglididine Sequential Dose-Finding for LMA Insertion Suppression | Experimental | Not described Receives: Drug: Taiglididine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with positive laryngeal mask insertion response
If the patient has movement during laryngeal mask insertion, twitching at the corner of the mouth, coughing, frowning, tearing, laryngospasm, bispectral index not decreasing to below 60, an increase in heart rate or blood pressure of more than 20% of the baseline value within 2 minutes after laryngeal mask insertion, tachycardia (heart rate >120 beats per minute), or hypertension (systolic blood pressure >180 mmHg), and one of these occurs, it is determined as a positive laryngeal mask insertion reaction; otherwise, it is negative.
Measured: Perioperative
Secondary outcomes (3)
Number of adverse reactions
Blood pressure elevation (systolic blood pressure/diastolic blood pressure >20% baseline), hypotension (systolic blood pressure/diastolic blood pressure <20% baseline or <85/50 mmHg), bradycardia (heart rate <50 bpm), tachycardia (heart rate >100 bpm), hypoxemia (pulse oximetry <92%), When 2 ml of propofol is injected, the patient is asked if there is any injection pain.
Measured: Perioperative
Number of successful cases of laryngeal mask placement
Number of successful cases of laryngeal mask placement
Measured: Perioperative
Adverse reactions such as pain, dizziness, headache, nausea and vomiting, sore throat, chills, choking, agitation, hoarseness of voice, and Intraoperative knowledge
The number of adverse reactions
Measured: Perioperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2025
- Study start1 Sep 2025 (estimated)
- Primary completion1 Jun 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urological SurgeryStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The First People's Hospital of Lianyungang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07096115
- Sponsor's protocol ID
- KY-20250324002-01
- Status last verified
- Jul 2025
- First submitted
- 26 Jun 2025
- Last updated
- 31 Jul 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 31 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The 90% Effective Dose of Taiglididine for Inhibiting Laryngeal Mask Insertion Response in Elderly Patients
- ClinicalTrials.gov ID
- NCT07096115
- Acronym / sponsor ID
- KY-20250324002-01
- Conditions
- Urological Surgery
- Keywords
- Taiglididine, Elderly Patients
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- The First People's Hospital of LianyungangUniversity, hospital or other
- Study start
- 1 Sep 2025 (estimated)
- Primary completion
- 1 Jun 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 31 Jul 2025 (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.
This research protocol aims to investigate the 90% effective dose (ED90) of taiglididine for inhibiting laryngeal mask insertion response in elderly patients. It is a non-randomized controlled trial using a biased coin design up-down method (BCD-UDM). A total of 54 elderly patients aged 65-80 years with ASA I-III, BMI 18-30 kg/m², and suitable for urological surgery under general anesthesia with laryngeal mask insertion will be enrolled. The first patient receives an intravenous injection of 1 mg taiglididine, followed by propofol and rocuronium. Subsequent doses of taiglididine are adjusted dynamically based on the previous patient's response: increasing by 0.1 mg if the insertion response is positive, or using BCD-UDM (11% probability to decrease by 0.1 mg, 89% to remain) if negative. The primary efficacy endpoint is the occurrence of laryngeal mask insertion response, while secondary endpoints include adverse events, vital sign changes, insertion success rate, and various time intervals. Safety is evaluated by monitoring vital signs. Statistical analysis will use SPSS 25.0 and R software to calculate ED90 and 95% confidence intervals via probit regression and bootstrap method, with at least 45 valid patients required to complete the trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Taiglididine Sequential Dose-Finding for LMA Insertion Suppression | Experimental | Drug: Taiglididine |
Who may qualify
- Ages
- 65 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (9 listed)
- Aged 65-80 years old.
- ASA physical status I-III.
- BMI 18-30 kg/m² (inclusive of critical values).
- Mallampati class I or II, mouth opening >2.5 cm.
- No abnormal airway or head/neck conditions.
Key exclusion criteria (6 listed)
- Baseline measurements: Severe hypertension (SBP >160 mmHg or DBP >100 mmHg), heart rate <60 bpm or >100 bpm.
- 2. History of long-term alcohol, sedative, or analgesic use; allergy to any study drugs.
- 3. Severe dysfunction of vital organs (heart, lung, liver, kidney, nervous system), neuromuscular diseases, hyperthyroidism, obstructive sleep apnea syndrome.
- 4. History of mental disorders or cognitive impairment severe enough to hinder understanding or cooperation with the study.
- 5. Preoperative administration of sedative-hypnotics (including benzodiazepines and barbiturates).
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 |
|---|---|---|
| TaiglididineThe first patient receives an intravenous injection of 1 mg taiglididine for anesthesia induction, followed by 1-2 mg/kg propofol. When the patient's bispectral index (BIS) drops below 60, eyelash reflex disappears, and MOAA/S score is 0, intravenous rocuronium 0.6 mg/kg is given, and a laryngeal mask is inserted by a senior anesthesiologist using a unified method 1 min later. From the second patient onward, the taiglididine dose is dynamically adjusted based on the previous patient's response to laryngeal mask insertion using BCD-UDM: if the previous patient shows a positive insertion response (positive response or MOAA/S ≥2 within 2 min after induction), the next patient's dose increases by 0.1 mg; if negative, a random number (1-95) generated by computer determines the dose: doses remain unchanged when the number is 6-95 (89% probability) and decrease by 0.1 mg when the number is 1-5 (11% probability). A collaborator not involved in result evaluation provides a sealed envelope with | Drug | Taiglididine Sequential Dose-Finding for LMA Insertion Suppression |
Primary outcome
Number of patients with positive laryngeal mask insertion response
Time frame: Perioperative
If the patient has movement during laryngeal mask insertion, twitching at the corner of the mouth, coughing, frowning, tearing, laryngospasm, bispectral index not decreasing to below 60, an increase in heart rate or blood pressure of more than 20% of the baseline value within 2 minutes after laryngeal mask insertion, tachycardia (heart rate >120 beats per minute), or hypertension (systolic blood pressure >180 mmHg), and one of these occurs, it is determined as a positive laryngeal mask insertion reaction; otherwise, it is negative.
3 secondary outcomes
Number of adverse reactions
Time frame: Perioperative
Number of successful cases of laryngeal mask placement
Time frame: Perioperative
Adverse reactions such as pain, dizziness, headache, nausea and vomiting, sore throat, chills, choking, agitation, hoarseness of voice, and Intraoperative knowledge
Time frame: Perioperative
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 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.
Questions about this trial
What is this clinical trial studying?
A study testing Taiglididine in people with Urological Surgery, run by The First People's Hospital of Lianyungang.
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 9 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: opening soon, as of the sponsor's last update on 31 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
Contact zhibin Zhao (+8618961326661, lygzhaozhibin@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients with positive laryngeal mask insertion response (time frame: Perioperative). 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 31 Jul 2025.