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.

Study Overview

• Status: Completed
• Conditions: Bleeding; Dexmedetomidine; Surgical Field
• Intervention / 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

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 118
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200031
      • Eye, Ear, Nose and Throat Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 61 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Eye & ENT Hospital of Fudan University
• Investigators: Study Director: Shenghai Zhang, Eye, Ear, Nose and Throat Hospital, Fudan University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2018
• Primary Completion (Actual): March 10, 2020
• Study Completion (Actual): March 10, 2020

Study Registration Dates

• First Submitted: February 9, 2020
• First Submitted That Met QC Criteria: February 17, 2020
• First Posted (Actual): February 19, 2020

Study Record Updates

• Last Update Posted (Actual): March 16, 2020
• Last Update Submitted That Met QC Criteria: March 12, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Tranquilizing Agents; Psychotropic Drugs; Hypnotics and Sedatives; Adjuvants, Anesthesia; Anti-Anxiety Agents; GABA Modulators; GABA Agents; Midazolam
• Other Study ID Numbers: EyeEntFudan2

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No