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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IV administration of dexmedetomidine | Experimental | IV administration of a single loading dose DEX (0.5μg/kg) |
|
| IV administration of midazolam | Active Comparator | IV administration of midazolam (0.05mg/kg) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IV administration of DEX to investigate the effects for functional nasal endoscopic surgery | Drug | IV administration of a single loading dose DEX (0.5μg/kg) after induction within 10 minutes. |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of surgical field according to the scale reported by Boezaart A.P. in the two groups | Levels of the scale reported by Boezaart A.P. as follows: 0. No bleeding.
Evaluation of surgical field was carried out by Kruskal-Wallis H test. | Through study completion, an average of 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Comparision of heart rate and mean blood pressure during anesthesia in the two groups | Heart rate (beats/minutes) and mean blood pressure (mmHg) were recorded every 10 minutes, and analyzed with Student's t-test | Through study completion, an average of 1 year |
| Comparision of recovery time and blood gas analysis in PACU in the two groups |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Shenghai Zhang | Eye, Ear, Nose and Throat Hospital, Fudan University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Eye, Ear, Nose and Throat Hospital | Shanghai | Shanghai Municipality | 200031 | China |
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| IV administration of Midazolam to investigate the effects for functional nasal endoscopic surgery | Drug | IV administration of midazolam (0.05mg/kg) after induction. |
|
Recovery time (minutes) included from entering to leaving PACU, and blood gas analysis just before leaving PACU |
| Through study completion, an average of 1 year |
| ID | Term |
|---|---|
| D006470 | Hemorrhage |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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