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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

118 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-01

Study Completion Date

2020-03-10

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.

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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.

Conditions

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Dexmedetomidine Bleeding Surgical Field

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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IV administration of dexmedetomidine

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

Group Type EXPERIMENTAL

IV administration of DEX to investigate the effects for functional nasal endoscopic surgery

Intervention Type DRUG

IV administration of a single loading dose DEX (0.5μg/kg) after induction within 10 minutes.

IV administration of Midazolam to investigate the effects for functional nasal endoscopic surgery

Intervention Type DRUG

IV administration of midazolam (0.05mg/kg) after induction.

IV administration of midazolam

IV administration of midazolam (0.05mg/kg)

Group Type ACTIVE_COMPARATOR

IV administration of DEX to investigate the effects for functional nasal endoscopic surgery

Intervention Type DRUG

IV administration of a single loading dose DEX (0.5μg/kg) after induction within 10 minutes.

IV administration of Midazolam to investigate the effects for functional nasal endoscopic surgery

Intervention Type DRUG

IV administration of midazolam (0.05mg/kg) after induction.

Interventions

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IV administration of DEX to investigate the effects for functional nasal endoscopic surgery

IV administration of a single loading dose DEX (0.5μg/kg) after induction within 10 minutes.

Intervention Type DRUG

IV administration of Midazolam to investigate the effects for functional nasal endoscopic surgery

IV administration of midazolam (0.05mg/kg) after induction.

Intervention Type DRUG

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