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Completed

NCT Number: NCT04276545

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

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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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Eye, Ear, Nose and Throat Hospital

Shanghai, Shanghai Municipality, 200031, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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

Drug

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

Primary outcomes

  1. Evaluation of surgical field according to the scale reported by Boezaart A.P. in the two groups

    Time frame: Through study completion, an average of 1 year

    Levels of the scale reported by Boezaart A.P. as follows:

    • 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.

Secondary outcomes

  1. Comparision of heart rate and mean blood pressure during anesthesia in the two groups

    Time frame: Through study completion, an average of 1 year

    Heart rate (beats/minutes) and mean blood pressure (mmHg) were recorded every 10 minutes, and analyzed with Student's t-test

  2. Comparision of recovery time and blood gas analysis in PACU in the two groups

    Time frame: Through study completion, an average of 1 year

    Recovery time (minutes) included from entering to leaving PACU, and blood gas analysis just before leaving PACU

Sponsors and collaborators

Lead sponsor

Eye & ENT Hospital of Fudan University

Other

Registry information

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Feb 19, 2020
Registry last updated
Mar 16, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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