Dexmedetomidine Improves the Surgical Field and Postoperative Recovery of Nasal Endoscopic Surgery

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Dexmedetomidine Improves the Surgical Field and Postoperative Recovery of Nasal Endoscopic Surgery

Conditions
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Dexmedetomidine, Bleeding, Surgical Field

Intervention / Treatment
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* Drug: IV administration of DEX to investigate the effects for functional nasal endoscopic surgery
* Drug: IV administration of Midazolam to investigate the effects for functional nasal endoscopic surgery


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 120 participants who diagnosed with nasosinusitis The participants need undergo functional nasal endoscopic surgery The participants signed the informed consent Exclusion Criteria: The participants were excluded with any diseases about respiration, circulation, liver and kidney The participants were rejected of the consent

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: IV administration of dexmedetomidine<br>IV administration of a single loading dose DEX (0.5μg/kg) | Drug: IV administration of DEX to investigate the effects for functional nasal endoscopic surgery<br>* IV administration of a single loading dose DEX (0.5μg/kg) after induction within 10 minutes.<br>Drug: IV administration of Midazolam to investigate the effects for functional nasal endoscopic surgery<br>* IV administration of midazolam (0.05mg/kg) after induction.<br>|
| Active Comparator: IV administration of midazolam<br>IV administration of midazolam (0.05mg/kg) | Drug: IV administration of DEX to investigate the effects for functional nasal endoscopic surgery<br>* IV administration of a single loading dose DEX (0.5μg/kg) after induction within 10 minutes.<br>Drug: IV administration of Midazolam to investigate the effects for functional nasal endoscopic surgery<br>* IV administration of midazolam (0.05mg/kg) after induction.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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. Slight bleeding - no suctioning of blood required. Slight bleeding - occasional suctioning required. Surgical field not threatened. Slight bleeding - frequent suctioning required. Bleeding threatens surgical field a few seconds after suction is removed. Moderate bleeding - frequent suctioning required. Bleeding threatens surgical field directly after suction is removed. Severe bleeding - constant suctioning required. Bleeding appears faster than can be removed by suction. Surgical field severely threatened and surgery not possible. Evaluation of surgical field was carried out by Kruskal-Wallis H test. | Through study completion, an average of 1 year | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |