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

NCT04276545 | Completed Phase 3

• 1 other identifier: EyeEntFudan2
• Study Type: interventional
• Target: 118
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Dexmedetomidine; Bleeding; Surgical Field

Outcome Measures

Primary Outcomes (1)

• 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. 1. Slight bleeding - no suctioning of blood required. 2. Slight bleeding - occasional suctioning required. Surgical field not threatened. 3. Slight bleeding - frequent suctioning required. Bleeding threatens surgical field a few seconds after suction is removed. 4. Moderate bleeding - frequent suctioning required. Bleeding threatens surgical field directly after suction is removed. 5. 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 Outcomes (2)

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

  Through study completion, an average of 1 year

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

  Through study completion, an average of 1 year

Study Arms (2)

IV administration of dexmedetomidine

EXPERIMENTAL

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

IV administration of midazolam

ACTIVE COMPARATOR

IV administration of midazolam (0.05mg/kg)

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

Interventions

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 dexmedetomidine; IV administration of midazolam

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

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

IV administration of dexmedetomidine; IV administration of midazolam

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• participants who diagnosed with nasosinusitis
• The participants need undergo functional nasal endoscopic surgery
• The participants signed the informed consent

You may not qualify if:

• The participants were excluded with any diseases about respiration, circulation, liver and kidney
• The participants were rejected of the consent

Sponsors & Collaborators

• Eye & ENT Hospital of Fudan University: lead

Study Sites (1)

Eye, Ear, Nose and Throat Hospital

Shanghai, Shanghai Municipality, 200031, China

Location

MeSH Terms

Conditions

Hemorrhage

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Shenghai Zhang

  Eye, Ear, Nose and Throat Hospital, Fudan University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending anesthesiologist

Study Record Dates

• First Submitted: February 9, 2020
• First Posted: February 19, 2020
• Study Start: January 1, 2018
• Primary Completion: March 10, 2020
• Study Completion: March 10, 2020
• Last Updated: March 16, 2020

Record last verified: 2020-03

Locations

CN (1)