Controlled Hypotension for Nasal SurgeriesEarly Phase 1NCT03059316
Effect of Hypotensive Anesthesia on the Perfusion Index
A Early Phase 1 study testing Massimo device, Nitroglycerin drug and Labetalol in people with Controlled Hypotension for Nasal Surgeries, run by Cairo University.
Trial summary
Controlled hypotension has been used as a mean of reducing intraoperative blood loss and better visualization of the surgical field in nasal surgeries. Perfusion index has been considered a useful tool for monitoring changes in peripheral perfusion using Masimo set and serum lactate for central perfusion. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Controlled Hypotension for Nasal Surgeries
- What is being tested?
- Massimo device, Nitroglycerin drug and Labetalol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 10 Jun 2016to 21 Apr 2017
- Phase
- Early Phase 1
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- ASA I-II males and females aged 18-45 years who were scheduled for Functional Endoscopic sinus surgery (FESS)
Who cannot join
- uncontrolled hypertension, cerebrovascular disorders, bleeding and coagulation disorders, coronary artery diseases, renal or hepatic diseases or known hypersensitivity to the drugs used and pregnant.
About this study
Official title: Department of Anestheia and Intensive Care Unit,Cairo University
Controlled hypotension has been used as a mean of reducing intraoperative blood loss and better visualization of the surgical field in nasal surgeries. Perfusion index has been considered a useful tool for monitoring changes in peripheral perfusion using Masimo set and serum lactate for central perfusion. Many medications were used to induce hypotension. In this study we will compare the effects of tridil and labetalol on the perfusion.
Read the detailed description
The purpose of this study to detect the degree of hypotension that helps the surgeon and dosen't impair patient's perfusion and to compare the hypotensive effects of both tridil and labetalol infusions on the perfusion.
- Being tested
- Massimo device, Nitroglycerin drug, Labetalol
- Keywords
- controlled hypotension, perfusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Massimo deviceCombination product
Massimo is a newly introduced device which can measure the peripheral organ perfusion and expressed it as perfusion index(PI).
Nitroglycerin drugDrug
Also called tridil
Nitroglycerin is a drug used as an hypotensive agent through its vasodilation effect on veins
LabetalolDrug
Also called trendate
Labetalol is an antagonist of adrenergic receptors (a1, b1, b2) which is used as an hypotensive inducer. This drug targets the beta receptors 5 to 10 times more specific than alpha receptors so that minor tachycardia happens
| Study group | Role | What they receive |
|---|---|---|
| nitroglycerin group | Active comparator | this group will receive nitroglycerin infusion for controlled hypotension.0.5-5ug/kg/min to keep MAP 55-65mmhg then Massimo device will be attached to the patients when MAP reached the desired level Receives: Combination Product: Massimo device; Drug: Nitroglycerin drug |
| labetalol group | Active comparator | this group will receive labetalol infusion fo controlled hypotension 0.4-3mg/kg/hr to keep MAP 55-65mmhg.then Massimo device will be attached to the patients when MAP reached the desired level Receives: Combination Product: Massimo device; Drug: Labetalol |
What is being measured
The primary outcome is the main question the study is designed to answer.
perfusion index
perfusion index is an indication of peripheral perfusion
Measured: 3hrs
serum lactate level
lactate level is an indication of central perfusion
Measured: 3hrs
Secondary outcomes (1)
surgical feild score
isan indication of adequacy of controlled hypotension
Measured: 3hrs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2017
- Study start10 Jun 2016
- Primary completion10 Apr 2017
- Study completion21 Apr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Controlled Hypotension for Nasal SurgeriesStudies of the same condition, open and under way.
- More trials run by Cairo 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
- Early Phase 1
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amany Hassan Saleh, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03059316
- Sponsor's protocol ID
- N532016
- Status last verified
- Jan 2019
- First submitted
- 7 Feb 2017
- Last updated
- 29 Mar 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Department of Anestheia and Intensive Care Unit,Cairo University
- ClinicalTrials.gov ID
- NCT03059316
- Acronym / sponsor ID
- N532016
- Keywords
- controlled hypotension, perfusion
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 10 Jun 2016 (actual)
- Primary completion
- 10 Apr 2017 (actual)
- Study completion
- 21 Apr 2017 (actual)
- First posted
- 23 Feb 2017 (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.
Controlled hypotension has been used as a mean of reducing intraoperative blood loss and better visualization of the surgical field in nasal surgeries. Perfusion index has been considered a useful tool for monitoring changes in peripheral perfusion using Masimo set and serum lactate for central perfusion. Many medications were used to induce hypotension. In this study we will compare the effects of tridil and labetalol on the perfusion.
Detailed description
The purpose of this study to detect the degree of hypotension that helps the surgeon and dosen't impair patient's perfusion and to compare the hypotensive effects of both tridil and labetalol infusions on the perfusion.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| nitroglycerin group | Active comparator | Combination Product: Massimo device, Drug: Nitroglycerin drugthis group will receive nitroglycerin infusion for controlled hypotension.0.5-5ug/kg/min to keep MAP 55-65mmhg then Massimo device will be attached to the patients when MAP reached the desired level |
| labetalol group | Active comparator | Combination Product: Massimo device, Drug: Labetalolthis group will receive labetalol infusion fo controlled hypotension 0.4-3mg/kg/hr to keep MAP 55-65mmhg.then Massimo device will be attached to the patients when MAP reached the desired level |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- ASA I-II males and females aged 18-45 years who were scheduled for Functional Endoscopic sinus surgery (FESS)
Key exclusion criteria (1 listed)
- uncontrolled hypertension, cerebrovascular disorders, bleeding and coagulation disorders, coronary artery diseases, renal or hepatic diseases or known hypersensitivity to the drugs used and pregnant.
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 |
|---|---|---|
| Massimo deviceMassimo is a newly introduced device which can measure the peripheral organ perfusion and expressed it as perfusion index(PI). | Combination product | labetalol group, nitroglycerin group |
| Nitroglycerin drugAlso: tridilNitroglycerin is a drug used as an hypotensive agent through its vasodilation effect on veins | Drug | nitroglycerin group |
| LabetalolAlso: trendateLabetalol is an antagonist of adrenergic receptors (a1, b1, b2) which is used as an hypotensive inducer. This drug targets the beta receptors 5 to 10 times more specific than alpha receptors so that minor tachycardia happens | Drug | labetalol group |
Primary outcome
perfusion index
Time frame: 3hrs
perfusion index is an indication of peripheral perfusion
serum lactate level
Time frame: 3hrs
lactate level is an indication of central perfusion
1 secondary outcome
surgical feild score
Time frame: 3hrs
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 29 Mar 2019.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Massimo device, Nitroglycerin drug and Labetalol in people with Controlled Hypotension for Nasal Surgeries, run by Cairo University.
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 29 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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?
perfusion index (time frame: 3hrs). The study lists 2 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 29 Mar 2019.