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

Eye & ENT Hospital of Fudan University

Status and phase: Completed; Phase 3

Conditions: Dexmedetomidine; Surgical Field; Bleeding

Treatments: 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

Study type: Interventional

Funder types: Other

Identifiers

NCT04276545

EyeEntFudan2

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 118 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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118 participants in 2 patient groups

IV administration of dexmedetomidine

Experimental group

Description:

IV administration of a single loading dose DEX (0.5μg/kg)

Treatment:

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

IV administration of midazolam

Active Comparator group

Description:

IV administration of midazolam (0.05mg/kg)

Treatment:

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