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Investigator requests withdrawal of !! Clinical Study on Accurate Control of Dexmedetomidine Dosage by Pupillary Measurement under Ultrasound

Clinical Study on Accurate Control of Dexmedetomidine Dosage by Pupillary Measurement under Ultrasound

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500097283
Enrollment
Unknown
Registered
2025-02-17
Start date
2025-02-20
Completion date
Unknown
Last updated
2025-08-25

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

Conditions

None

Interventions

Heart rate+blood pressure group:Patients in this group will be given midazolam for 5 minutes, and their heart rate and blood pressure will be measured as baseline values, and then recorded every 5 min
Conversely, if the heart rate slows down or the systolic blood pressure decreases to 85% of the baseline value, the pumping speed of dexmedetomidine will be reduced by 0.05 µ g/kg/h.
Bispectral index of EEG group:After anesthesia induction, the tracheal catheter of this group of patients was properly fixed. At this moment, the value was read as the baseline value of anesthesia dep
On the other hand, BIS<=39 will reduce the pumping speed of dexmedetomidine by 0.05 µ g/kg/h.
Pupil measurement under ultrasound group :Five minutes after the patients in this group were given midazolam, the researchers will use ultrasound to measure the pupil diameter as the baseline value, a

Sponsors

The First Affiliated Hospital of Chengdu Medical College
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: From February, 2025 to May, 2025, the First Affiliated Hospital of Chengdu Medical College planned to perform laparoscopic surgery under combined intravenous anesthesia. (1) Basic information: non-pregnant, non-breastfeeding patients aged 18 and above; ASA classification I~II; Body mass index is 18.5 ~ 23.9 kg/m^2; (2) Inspection: ECG diagnosis is 'sinus rhythm, normal ECG'; There is no obvious abnormality in chest CT and/or X-ray; The results of blood biochemistry (liver and kidney function, electrolyte, blood routine, coagulation function, infectious disease antigen antibody, etc.) were not obviously abnormal; (3) Past history: no pre-clinical and clinically diagnosed chronic heart and lung diseases, no neurological and mental system diseases, no history of eye injuries, eye diseases and high myopia (myopia degree is greater than 600 degrees), no history of using analgesic and sedative drugs, anticoagulants and vasoactive drugs before operation, no history of allergy and antiallergic treatment, no history of malignant tumors, radiotherapy and chemotherapy, and no history of systemic infection; (4) Specialized examination of anesthesia: metabolic equivalent>=3 mets; No smoking or drinking within 2 weeks before operation; The mobility of the neck and temporomandibular joint is good, Mallampati grade is 1-II, the mouth opening degree is >=3.5cm or the patient's three horizontal fingers, the distance of the chin is >=6.5cm, and the teeth are intact without looseness or loss.

Exclusion criteria

Exclusion criteria: (1) Basic information: patients under 18 years old, pregnant and breastfeeding patients; ASA grade III and above; BMI 23.9 kg/m^2; (2) Inspection: abnormal electrocardiogram; Chest CT and/or X-ray are significantly abnormal; There is significant abnormality in any of the blood biochemical indexes; (3) Past history: including but not limited to acute and chronic diseases of heart, lung, liver and kidney, diseases of nervous and mental system, history of eye injury, eye diseases and high myopia, preoperative use of special drugs, history of adverse events related to narcotic drugs, history of allergy and antiallergic treatment, and acute and chronic systemic infection; (4) Specialized examination of anesthesia: metabolic equivalent < 3 mets; Did not quit smoking and drinking within 2 weeks before operation; There are one or more difficult airway finger syndromes, such as insufficient mobility or dislocation of the neck and temporomandibular joint, Mallampati grade III or above, mouth opening less than 3.5cm or the patient's three horizontal fingers, and nail mental distance less than 6.5cm;; Loose and missing teeth.

Design outcomes

Primary

MeasureTime frame
Number of changes in pumping speed of dexmedetomidine;Variation coefficient of pumping speed of dexmedetomidine;Total consumption of dexmedetomidine;Awakening event;Occurrence of adverse events;

Secondary

MeasureTime frame
Gender;Age;Height;Weight;ASA grading;Total duration of operation;Total duration of anesthesia;Heart rate;Invasive systolic blood pressure;Mean arterial pressure;Bispectral index of EEG;Pupil diameter;Pupillary pain index;Response Time of Dexmedetomidine Pumping Speed Adjustment;Total consumption of opioids;Total sevoflurane consumption;

Countries

China

Contacts

Public ContactDan Huang

The First Affiliated Hospital of Chengdu Medical College

huangdan1790@163.com+86 159 0817 1790

Outcome results

None listed

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