DexmedetomidinePhase 3NCT04276545
Dexmedetomidine Improves the Surgical Field and Postoperative Recovery of Nasal Endoscopic Surgery
A Phase 3 study testing IV administration of DEX to investigate the effects for functional nasal endoscopic surgery and IV administration of Midazolam to investigate the effects for functional nasal endoscopic surgery in people with Dexmedetomidine and Bleeding, run by Eye & ENT Hospital of Fudan University at 1 site in China.
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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Dexmedetomidine, Bleeding, Surgical Field
- What is being tested?
- IV administration of DEX to investigate the effects for functional nasal endoscopic surgery and IV administration of Midazolam to investigate the effects for functional nasal endoscopic surgery
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 118 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2018to 10 Mar 2020
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 120 participants who diagnosed with nasosinusitis
- The participants need undergo functional nasal endoscopic surgery
- The participants signed the informed consent
Who cannot join
- The participants were excluded with any diseases about respiration, circulation, liver and kidney
- The participants were rejected of the consent
Trial locations and contacts
1 site in 1 country.
China1 site
Eye, Ear, Nose and Throat Hospital
Shanghai, Shanghai Municipality, 200031
About this study
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.
Read the 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.
- Conditions
- Dexmedetomidine, Bleeding, Surgical Field
- Being tested
- IV administration of DEX to investigate the effects for functional nasal endoscopic surgery, IV administration of Midazolam to investigate the effects for functional nasal endoscopic surgery
- Medical subject headings
- Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IV administration of DEX to investigate the effects for functional nasal endoscopic surgeryDrug
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 surgeryDrug
IV administration of midazolam (0.05mg/kg) after induction.
| Study group | Role | What they receive |
|---|---|---|
| IV administration of dexmedetomidine | Experimental | IV administration of a single loading dose DEX (0.5μg/kg) Receives: 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) Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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:
- 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.
Measured: 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
Heart rate (beats/minutes) and mean blood pressure (mmHg) were recorded every 10 minutes, and analyzed with Student's t-test
Measured: 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
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2020
- Study start1 Jan 2018
- Primary completion10 Mar 2020
- Study completion10 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DexmedetomidineStudies of the same condition, open and under way.
- More trials run by Eye & ENT Hospital of Fudan UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 118 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eye & ENT Hospital of Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jinhong Wu, Eye & ENT Hospital of Fudan University
- Investigators
- Shenghai Zhang, Study director, Eye, Ear, Nose and Throat Hospital, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04276545
- Sponsor's protocol ID
- EyeEntFudan2
- Status last verified
- Mar 2020
- First submitted
- 9 Feb 2020
- Last updated
- 16 Mar 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dexmedetomidine Improves the Surgical Field and Postoperative Recovery of Nasal Endoscopic Surgery
- ClinicalTrials.gov ID
- NCT04276545
- Acronym / sponsor ID
- EyeEntFudan2
- Conditions
- Dexmedetomidine, Bleeding, Surgical Field
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 118 participants (actual)
- Lead sponsor
- Eye & ENT Hospital of Fudan UniversityUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 10 Mar 2020 (actual)
- Study completion
- 10 Mar 2020 (actual)
- First posted
- 19 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IV administration of dexmedetomidine | Experimental | 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 surgeryIV administration of a single loading dose DEX (0.5μg/kg) |
| IV administration of midazolam | Active comparator | 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 surgeryIV administration of midazolam (0.05mg/kg) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 120 participants who diagnosed with nasosinusitis
- The participants need undergo functional nasal endoscopic surgery
- The participants signed the informed consent
Key exclusion criteria (2 listed)
- The participants were excluded with any diseases about respiration, circulation, liver and kidney
- The participants were rejected of the consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IV administration of DEX to investigate the effects for functional nasal endoscopic surgeryIV administration of a single loading dose DEX (0.5μg/kg) after induction within 10 minutes. | Drug | IV administration of dexmedetomidine, IV administration of midazolam |
| IV administration of Midazolam to investigate the effects for functional nasal endoscopic surgeryIV administration of midazolam (0.05mg/kg) after induction. | Drug | IV administration of dexmedetomidine, IV administration of midazolam |
Primary outcome
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: 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.
2 secondary outcomes
Comparision of heart rate and mean blood pressure during anesthesia in the two groups
Time frame: Through study completion, an average of 1 year
Comparision of recovery time and blood gas analysis in PACU in the two groups
Time frame: Through study completion, an average of 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shenghai Zhang study director
Eye, Ear, Nose and Throat Hospital, Fudan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing IV administration of DEX to investigate the effects for functional nasal endoscopic surgery and IV administration of Midazolam to investigate the effects for functional nasal endoscopic surgery in people with Dexmedetomidine and Bleeding, run by Eye & ENT Hospital of Fudan University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2020.