AnesthesiaNCT04903483
Anesthesia of Endolaryngeal Laser Surgery and Perioperative Side Effects
A study testing bispectral index monitoring in people with Anesthesia, run by University of Pecs at 2 sites in Hungary.
Trial summary
Investigators analyze the anesthesia of the endolaryngeal laser surgery in patients with smoking with or without monitoring of depth of anesthesia (bispectral index) Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Anesthesia
- What is being tested?
- bispectral index monitoring
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 2 sitesHungary
- Study dates
- 18 Jun 2021to 29 Nov 2024
- Phase
- Interventional
- 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
- endolaryngeal laser surgery with target-controlled anesthesia
Who cannot join
- epilepsy, psychiatric illness, cerebrovascular or congenital neuromuscular disease
Trial locations and contacts
2 sites in 1 country.
Hungary2 sites
Department of Anaesthesiology and Intensive Therapy
Pécs, Ifjuság Str.13., 7624
PTE Department of ENT
Pécs
About this study
Investigators analyze the anesthesia of the endolaryngeal laser surgery in patients with smoking with or without monitoring of depth of anesthesia (bispectral index)
Read the detailed description
All participants are informed about the investigation and are signed the Informed Consent before anesthesia. The study takes place at the Department of Otorhinolaryngology, University of Pecs, Hungary. Between June 2021 and May 2022 ASA I or II patients aged 18-65 years, scheduled for elective endolaryngeal laser surgery with TCI (target-controlled infusion, propofol). Exclusion criteria are epilepsy, psychiatric illness, cerebrovascular or congenital neuromuscular disease. Participants are randomized to two anesthetic groups, anesthesia with or without bispectral index monitoring.
- Conditions
- Anesthesia
- Being tested
- bispectral index monitoring
- Keywords
- laser, anesthesia, bispectral index, postoperative delirium
- Medical subject headings
- Emergence Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bispectral index monitoringOther
Also called depth of anesthesia
intraoperative single-channel electroencephalography monitoring of the depth of anesthesia
| Study group | Role | What they receive |
|---|---|---|
| target-controlled infusion (propofol) with depth of anesthesia monitoring | Other | In this group, propofol dosing is adjusted with bispectral index monitoring. Receives: Other: bispectral index monitoring |
| target-controlled infusion (propofol) without depth of anesthesia monitoring | Other | In this group, propofol dosing is adjusted without bispectral index monitoring. Receives: Other: bispectral index monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
circulation
blood pressure (mmHg)
Measured: through study completion, an average of 1 year
cardiac function
pulse rate (beats/minute)
Measured: through study completion, an average of 1 year
oxygenization
oxygen saturation (%)
Measured: through study completion, an average of 1 year
ventilation
end-tidal carbon-dioxide (mmHg)
Measured: through study completion, an average of 1 year
depth of anesthesia
bispectral index level (number between 1-100), the target intraoperative level 40-60, lower and higher are worse
Measured: through study completion, an average of 1 year
Secondary outcomes (1)
cognitive functions
cognitive functions test (Montreal Cognitive Assessment) score (number between 0-30, minimum=0, maximum=30), higher number is better
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 posted26 May 2021
- Study start18 Jun 2021
- Primary completion25 Nov 2024
- Study completion29 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- the side effects of endolaryngeal laser surgery's anesthesia with or without bispectral index monitoring in patients with smoking
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pecs
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Timea Bocskai, University of Pecs
- Investigators
- Burian Andras, MD, Study chair, University of Pecs Department of ENT
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04903483
- Sponsor's protocol ID
- 6218-2021
- Status last verified
- Nov 2024
- First submitted
- 22 May 2021
- Last updated
- 3 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anesthesia of Endolaryngeal Laser Surgery and Perioperative Side Effects
- ClinicalTrials.gov ID
- NCT04903483
- Acronym / sponsor ID
- 6218-2021
- Conditions
- Anesthesia
- Keywords
- laser, anesthesia, bispectral index, postoperative delirium
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of PecsUniversity, hospital or other
- Study start
- 18 Jun 2021 (actual)
- Primary completion
- 25 Nov 2024 (actual)
- Study completion
- 29 Nov 2024 (actual)
- First posted
- 26 May 2021 (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.
Investigators analyze the anesthesia of the endolaryngeal laser surgery in patients with smoking with or without monitoring of depth of anesthesia (bispectral index)
Detailed description
All participants are informed about the investigation and are signed the Informed Consent before anesthesia. The study takes place at the Department of Otorhinolaryngology, University of Pecs, Hungary. Between June 2021 and May 2022 ASA I or II patients aged 18-65 years, scheduled for elective endolaryngeal laser surgery with TCI (target-controlled infusion, propofol). Exclusion criteria are epilepsy, psychiatric illness, cerebrovascular or congenital neuromuscular disease. Participants are randomized to two anesthetic groups, anesthesia with or without bispectral index monitoring.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- the side effects of endolaryngeal laser surgery's anesthesia with or without bispectral index monitoring in patients with smoking
| Arm | Type | Receives |
|---|---|---|
| target-controlled infusion (propofol) with depth of anesthesia monitoring | Other | Other: bispectral index monitoringIn this group, propofol dosing is adjusted with bispectral index monitoring. |
| target-controlled infusion (propofol) without depth of anesthesia monitoring | Other | Other: bispectral index monitoringIn this group, propofol dosing is adjusted without bispectral index monitoring. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- endolaryngeal laser surgery with target-controlled anesthesia
Key exclusion criteria (1 listed)
- epilepsy, psychiatric illness, cerebrovascular or congenital neuromuscular disease
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 |
|---|---|---|
| bispectral index monitoringAlso: depth of anesthesiaintraoperative single-channel electroencephalography monitoring of the depth of anesthesia | Other | target-controlled infusion (propofol) with depth of anesthesia monitoring, target-controlled infusion (propofol) without depth of anesthesia monitoring |
Primary outcome
circulation
Time frame: through study completion, an average of 1 year
blood pressure (mmHg)
cardiac function
Time frame: through study completion, an average of 1 year
pulse rate (beats/minute)
oxygenization
Time frame: through study completion, an average of 1 year
oxygen saturation (%)
ventilation
Time frame: through study completion, an average of 1 year
end-tidal carbon-dioxide (mmHg)
depth of anesthesia
Time frame: through study completion, an average of 1 year
bispectral index level (number between 1-100), the target intraoperative level 40-60, lower and higher are worse
1 secondary outcome
cognitive functions
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 3 Dec 2024.
Related trials for Anesthesia
Not yet recruitingObservational study
"Comparison of Oxygen Reserve Index (ORI), End-Tidal Oxygen, and Time-Based Preoxygenation Targets With Arterial Blood Gas During Preoxygenation
Preoxygenation Adequacy Assessed by Oxygen Reserve Index, End-tidal Oxygen and Arterial Blood Gas
RecruitingObservational study
Comparison of Hemodynamic Responses During Anesthesia Induction Using Eleveld and Schnider
Spinal (Fusion) Surgery, Total Intravenous Anesthesia
Not yet recruiting
A Randomized Controlled SaCo-VLM Trial
General Anaesthesia Using Supraglotic Airway
Not yet recruiting
Bispectral Index-Guided Propofol Sedation During Endoscopic Retrograde Cholangiopancreatography
Deep Sedation, Endoscopic Retrograde Cholangiopancreatography
RecruitingPhase 4
Comparison of Hemodynamics and Respiratory Function Between Ciprofol and Propofol in Elderly Patients Undergoing Non-intubated General Anesthesia
Comparison of Hemodynamics and Respiratory Function Between Ciprofol and Propofol in Elderly Patients Undergoing Non-intubated General Anesthesia
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.
Burian Andras, MD study chair
University of Pecs Department of ENT
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing bispectral index monitoring in people with Anesthesia, run by University of Pecs at 2 sites in Hungary.
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 1 inclusion and 1 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 3 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Hungary. 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.
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?
circulation (time frame: through study completion, an average of 1 year). The study lists 5 primary outcomes in all. 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 3 Dec 2024.