The study is being conducted to evaluate the efficacy, and safety of dexmedetomidine hydrochloride nasal spray for preoperative sedation in adults. To explore the reasonable dosage of dexmedetomidine hydrochloride nasal spray for preoperative sedation.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
201
dexmedetomidine nasal spray
dexmedetomidine hydrochloride nasal spray blank preparation
Zhongshan Hospital Fudan University
Shanghai, Shanghai Municipality, China
Proportion of subjects who meet the Ramsay sedation score of 3 at least once within 45 minutes
Evaluated with Ramsay sedation scale Score Response 1. Anxious or restless or both 2. Cooperative, orientated and tranquil 3. Responding to commands 4. Brisk response to stimulus 5. Sluggish response to stimulus 6. No response to stimulus
Time frame: 0 minute to 45 minutes after administration
Total consumption of propofol during bispectral index reaches 60 for the first time
Total consumption of propofol during bispectral index reaches 60 for the first time
Time frame: The bispectral index reaches 60 for the first time during intraoperative
Total consumption of propofol during general anesthesia
Total consumption of propofol during general anesthesia
Time frame: From the beginning of anesthesia to the end of surgical operation up to 4 hours
Total consumption of opioid analgesic during bispectral index reaches 60 for the first time
Total consumption of opioid analgesic during bispectral index reaches 60 for the first time
Time frame: The bispectral index reaches 60 for the first time during intraoperative
Total consumption of opioid analgesic during general anesthesia
Total consumption of opioid analgesic during general anesthesia
Time frame: From the beginning of anesthesia to the end of surgical operation up to 4 hours
The BIS value for the Ramsay sedation score of 3 for the first time after administration
The BIS value for the Ramsay sedation score of 3 for the first time after administration
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Time frame: The Ramsay sedation score of 3 for the first time during intraoperative
Anesthesiologist satisfaction rating
The anesthesiologist satisfaction rating is a scale of 0 to 10, satisfaction defined as a scale of 10, dissatisfaction defined as a scale of 0.
Time frame: At the end of surgery when the patient recovers from anesthesia
Subjects' satisfaction rating
The subjects' satisfaction rating is a scale of 0 to 10, satisfaction defined as a scale of 10, dissatisfaction defined as a scale of 0.
Time frame: From the end of surgical operation up to 24 hours