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Sequential method was used to determine the half effective concentration of opioids under propofol sedation to inhibit tracheal intubation reaction in general anesthesia patients

Sequential method was used to determine the half effective concentration of opioids under propofol sedation to inhibit tracheal intubation reaction in general anesthesia patients: a single-center, randomized, double-blind study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200064932
Enrollment
Unknown
Registered
2022-10-24
Start date
2022-11-01
Completion date
Unknown
Last updated
2023-05-15

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

Conditions

patients undergoing general anesthesia

Interventions

Group A:TCI pump alfentanil to the effect chamber concentration of 90 ng/ml (Maitre model), the concentration gradient is 3 ng/ml
Group R:TCI pump remifentanil to the effect chamber concentration of 3 ng/ml (Minto model), the concentration gradient is 0.3 ng/ml
Group E:After esketamine 0.3 mg/kg intravenously, TCI pump remifentanil to the effect chamber concentration of 3 ng/ml (Minto model), the concentration gradient is 0.3 ng/ml

Sponsors

Chongqing University Fuling Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Age 18-65 years old (including 18 and 65 years old); 2. ASA I-II level; 3. 18 kg/m^2 <= BMI <= 30 kg/m^2; 4. Patients undergoing elective general anesthesia (only tracheal intubation and mechanical ventilation, 1 h <= estimated anesthesia time <= 2.5 h); 5. Subjects volunteered to participate in this experiment and signed an informed consent form.

Exclusion criteria

Exclusion criteria: 1. There are contraindications to general anesthesia; 2. Besides general anesthesia, other anesthesia methods should be combined; 3. Patients who are known to be intolerant or allergic to escitalopram, alfentanil, remifentanil, propofol and rocuronium bromide; 4. Abnormal coagulation function (PT or PT-INR >= 1.5 × ULN), bleeding tendency (such as active digestive tract ulcer) or being treated with anticoagulation or thrombolysis; 5. Abnormal liver function (ALT and/or AST >= 1.5 × ULN, TBIL >= 1.5 × ULN); 6. Abnormal renal function, BUN >= 1.5 × ULN, and serum creatinine exceeding the upper limit of normal value; 7. Patients with severe cardiovascular history (such as coronary atherosclerotic heart disease, heart failure, arrhythmia to be treated, etc.), unstable angina pectoris, or myocardial infarction in the last 6 months; 8. Those whose blood pressure has not been satisfactorily controlled (SBP >= 160 mmHg and/or DBP >= 110 mmhg in screening period); 9. Those who have a history of craniocerebral injury, intracranial hypertension, cerebral aneurysm and cerebrovascular accident; 10. Diabetic patients whose blood sugar has not been satisfactorily controlled (fasting blood sugar >= 11.1 mmol/L in screening period); 11. Patients with a history of hyperthyroidism; 12. Patients with elevated intraocular pressure (such as glaucoma) or history of penetrating eye injury; 13. Patients with mental diseases (schizophrenia, mania, bipolar disorder, insanity, etc.) and long-term history of taking psychotropic drugs and cognitive dysfunction; 14. Patients with a history of asthma; 15. Patients who are judged to have difficulty in respiratory management (the modified Markov score is grade IV); 16. History of drug abuse and alcohol abuse within 2 years before the start of the screening period: alcohol abuse is defined as drinking more than 14 times/week on a regular basis (1 time = 150 ml wine or 360 ml beer or 45 ml spirits); 17. Pregnant or lactating women.

Design outcomes

Primary

MeasureTime frame
adrenergic response;

Countries

China

Contacts

Public ContactXue Yun

Chongqing University Fuling Hospital

2636238206@qq.com+86 13896620121

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 9, 2026