Status:
COMPLETED
Dexmedetomidine Versus Propofol for Sedation During Awake Endotracheal Intubation
Lead Sponsor:
Sixth Affiliated Hospital, Sun Yat-sen University
Conditions:
Sedation
Intubation
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
Brief Summary
The purpose of this study is to compare the sedation effect of dexmedetomidine and propofol when they are both combined with midazolam and remifentanil during awake endotracheal intubation.
Detailed Description
Awake intubation is one of the best strategy guaranteed by the American Society of Anesthesiologists (ASA) guidelines for the management of patients with anticipated difficult airways. Hemodynamic sta...
Eligibility Criteria
Inclusion
- Age 18-65 Years old;
- scheduled for elective surgery under general anesthesia with oral tracheal intubation;
- The American Society of Anesthesiologists(ASA) grade is I or II, and the cardiac function is 1-2;
- Body mass index (BMI) 18-30 kg/m2.
Exclusion
- Patients have severe cardiac diseases (cardiac function grading greater than grade 3/arrhythmia including sick sinus syndrome, atrial fibrillation, atrial flutter, atrioventricular block, frequent ventricular premature, multiple ventricular premature, ventricular premature R on T, ventricular fibrillation and ventricular flutter/acute coronary syndrome) or respiratory failure or hepatic failure or renal failure;
- body mass index (BMI) ≥30 kg/m2 or \<18 kg/m2;
- Patients with poor blood pressure control (receive regular antihypertensive medical treatment but still have systolic blood pressure \> 150 mmHg and/or diastolic blood pressure \> 90 mmHg);
- Patients with a higher risk of reflux and aspiration, such as full stomach, gastrointestinal obstruction, gastroparesis, and pregnant women;
- Patients have schizophrenia, epilepsy, Parkinson's disease, intellectual disability, hearing impairment.;
- Patients who take sedative and analgesic drugs for a long time;
- Patients who are allergic to propofol, dexmedetomidine, midazolam or remifentanil
- Patients who are expected to be difficult to intubate;
- Patients who are participating in other clinical trials, or who refuse to sign informed consent.
Key Trial Info
Start Date :
March 5 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2021
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT04753515
Start Date
March 5 2021
End Date
May 1 2021
Last Update
November 30 2022
Active Locations (1)
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1
the Sixth Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China, 510655