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

Bleeding Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04276545
• Other study ID #: EyeEntFudan2
• Status: Completed
• Phase: Phase 3
• Start date: January 1, 2018
• Est. completion date: March 10, 2020

Study information

• Verified date: March 2020
• Source: Eye & ENT Hospital of Fudan University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 118
• Est. completion date: March 10, 2020
• Est. primary completion date: March 10, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Bleeding
• Dexmedetomidine
• Hemorrhage
• Surgical Field

Intervention

Drug:
• 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.
• IV administration of Midazolam to investigate the effects for functional nasal endoscopic surgery
IV administration of midazolam (0.05mg/kg) after induction.

Locations

Country	Name	City	State
China	Eye, Ear, Nose and Throat Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Eye & ENT Hospital of Fudan University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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