Eye, Ear, Nose and Throat Hospital
Shanghai, Shanghai Municipality, 200031, China
NCT Number: NCT04276545
Studies showed dexmedetomidine (DEX) could improve surgical field, but the effect for functional nasal endoscopic surgery (FESS) was unclear. The investigators explored IV administration of a single loading dose DEX (0.5μg/kg) for FESS, and IV administration of midazolam (0.05mg/kg) as a control with comparision of surgical field, haemodynamics, ventilation parameters and recovery.
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Notify Me18 year–65 year
All sexes
Interventional
Phase 3
Shanghai, Shanghai Municipality, 200031, China
The participants received an induction of anesthesia with propofol 2-3 mg/kg, sufentanyl 0.2 μg/kg, and rocuronium 0.6 mg/kg, and then insertion of a flexible laryngeal mask airway was conducted using the index finger insertion technique by anesthesia providers with a minimum of four years endotracheal intubation experience. Mechanical ventilation parameters were as follows: pressure-controlled ventilation mode, ventilation pressure: 12, respiratory rate: 12, oxygen concentration: 50%. The maintenance of general anesthesia was performed with sevoflurane at minimum alveolar concentration of 1.3. After induction, a single loading dose DEX (0.5μg/kg) was IV infusion within 10 minutes, or IV administration of midazolam (0.05mg/kg). Heart rate, blood pressure, tidal volume, ventilation pressure and ETCO2 after insertion of a LMA, 10 minutes, 20 minutes, 30 minutes after drug infusion and transferred to PACU, besides heart rate and blood pressure were recorded before and after induction. Surgical field was evaluated at the time of 10 minutes and 20 minutes after drug infusion. Blood gas analysis was performed just transferred to PACU and before transferred to ward.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
IV administration of a single loading dose DEX (0.5μg/kg) after induction within 10 minutes.
IV administration of midazolam (0.05mg/kg) after induction.
Time frame: Through study completion, an average of 1 year
Levels of the scale reported by Boezaart A.P. as follows:
Evaluation of surgical field was carried out by Kruskal-Wallis H test.
Time frame: Through study completion, an average of 1 year
Heart rate (beats/minutes) and mean blood pressure (mmHg) were recorded every 10 minutes, and analyzed with Student's t-test
Time frame: Through study completion, an average of 1 year
Recovery time (minutes) included from entering to leaving PACU, and blood gas analysis just before leaving PACU
Eye & ENT Hospital of Fudan University
Other
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