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Tegretolide inhibits 90% effective dose of laryngeal mask placement reactions in the elderly

Tegretolide inhibits 90% effective dose of laryngeal mask placement reactions in the elderly

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500106673
Enrollment
Unknown
Registered
2025-07-28
Start date
2025-09-01
Completion date
Unknown
Last updated
2025-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None

Interventions

Tegretolide group:The first patient was initiated with induction of anesthesia by intravenous tegiridine 1 mg, followed by 1-2 mg/kg propofol. When the patients electroencephalogram bifrequency index
If the previous patient had a negative reaction to laryngeal mask placement, the dose was determined by BCD-UDM randomization: a computer was used to generate a random number with a range of 1~95, and
When the random number is 1~5, the next patient has a gradient drop in tagliridine dose, that is, there is an 11% (b=0.11) probability of decreasing by one gradient (0.1mg) and an 89% (1-b=0.89) proba

Sponsors

The First People’s Hospital of Lianyungang
Lead Sponsor

Eligibility

Sex/Gender
All
Age
65 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1.Aged between 65 and 80 years old; 2.ASA physical status I-III; 3.BMI between 18 and 30 kg/m^2 (including boundary values); 4.Mallampati grade I or II, mouth opening >2.5 cm; 5.No airway, head and neck condition abnormalities; 6.No risk of regurgitation and aspiration (such as in cases of full stomach, obesity, gastrointestinal obstruction, etc.); 7.Estimated operative time <180 minutes; 8.Scheduled for urological surgery requiring general anesthesia and laryngeal mask airway insertion; 9.Subjects voluntarily participate in this study and sign the informed consent form;

Exclusion criteria

Exclusion criteria: 1.Baseline measurements: severe hypertension (systolic blood pressure over 160 mmHg or diastolic blood pressure over 100 mmHg), heart rate below 60 beats per minute or above 100 beats per minute; 2.Long-term use of alcohol, sedatives, and analgesics, or allergy to any drugs used in the study; 3.Significant organ dysfunction in heart, lung, liver, kidney, nervous system, neuromuscular diseases, hyperthyroidism, obstructive sleep apnea syndrome; 4.History of mental illness or severe cognitive impairment that prevents understanding of study content and cooperation; 5.Administration of sedative-hypnotic drugs (including benzodiazepines and barbiturates) before surgery; 6.Upper respiratory tract infection within 1 month before surgery; 7.Participation in other clinical trials within the last 3 months; 8.Other reasons deemed unsuitable for participation in the trial by the researcher;

Design outcomes

Primary

MeasureTime frame
Whether a reaction to laryngeal mask placement occurs;

Secondary

MeasureTime frame
Number of successful cases of laryngeal mask placement;Number of adverse reactions;Blood pressure;Adverse Reaction Rate;Heart rate;Pulse Oxygen Saturation;Bispectral Index;

Countries

China

Contacts

Public ContactZhao Zhibin

The First People’s Hospital of Lianyungang

lygzhaozhibin@163.com+86 18961326661

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026