Hypotensive AnesthesiaNCT03774693
Regional Block of the Nose for Hypotensive Anaesthesia in Septo-rhinoplasty
A study testing General anesthesia with fentanyl boluses and Regional block in people with Hypotensive Anesthesia, run by Ain Shams University at 1 site in Egypt.
Trial summary
Septorhinoplasty is a cosmetic surgery that many people are choosing to undergo. It can be done under general anesthesia, twilight anesthesia or regional anesthesia. Controlled hypotensive anesthesia is required to minimize bruising, swelling, and bleeding that reduces visibility in the operative field and hence… Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Hypotensive Anesthesia
- What is being tested?
- General anesthesia with fentanyl boluses and Regional block
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 28 Nov 2018to Mar 2019
- 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 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- American Society of Anesthesiologists (ASA) physical status I-II
- Scheduled for elective septo-rhinoplasty surgery
Who cannot join
- Patients with hypertension or coronary artery disease,
- Patients with renal, hepatic or cerebral insufficiency,
- Patients with coagulopathy or receiving drugs influencing blood coagulation,
- Patients with known sensitivity to any of the study drug
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Regional Block of the Nose in Achieving Hypotensive Anaesthesia in Septo-rhinoplasty Surgery
Septorhinoplasty is a cosmetic surgery that many people are choosing to undergo. It can be done under general anesthesia, twilight anesthesia or regional anesthesia. Controlled hypotensive anesthesia is required to minimize bruising, swelling, and bleeding that reduces visibility in the operative field and hence satisfactory surgical outcome.
The goal of our study to prove that regional block of the nose provides efficient hypotensive anesthesia
- Conditions
- Hypotensive Anesthesia
- Being tested
- General anesthesia with fentanyl boluses, Regional block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
General anesthesia with fentanyl bolusesOther
Patients will receive general anesthesia with Fentanyl boluses of 0.5 mcg.Kg-1 given to maintain MAP between 55-65 mmHg with a maximum dose of 3 mcg.Kg-1
Regional blockProcedure or surgery
Patients will receive trans-oral bilateral sphenopalatine ganglion block and trans-oral bilateral infraorbital nerve block.
| Study group | Role | What they receive |
|---|---|---|
| GS [General anesthesia] | Active comparator | Patients will receive general anesthesia with Fentanyl boluses of 0.5 mcg.Kg-1 given to maintain MAP between 55-65 mmHg with a maximum dose of 3 mcg.Kg-1. Receives: Other: General anesthesia with fentanyl boluses |
| GR [General anesthesia + regional block] | Active comparator | Patients will receive general anesthesia with Fentanyl boluses of 0.5 mcg.Kg-1 given to maintain MAP between 55-65 mmHg with a maximum dose of 3 mcg.Kg-1.
Also patients will receive trans-oral bilateral sphenopalatine ganglion block and trans-oral bilateral infraorbital nerve block. Fentanyl boluses of 0.5 mcg.Kg-1 will be given when needed to maintain MAP between 55-65 mmHg with a maximum dose of 3 mcg.Kg-1. Receives: Other: General anesthesia with fentanyl boluses; Procedure: Regional block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hypotensive anesthesia
Measurement of Mean arterial blood pressure
Measured: Intraoperative
Requirements of Fentanyl
Assessment of intraoperative fentanyl doses of [Fentanyl boluses of 0.5 mcg.Kg-1 will be given to maintain mean arterial pressure (MAP) between 55-65 mmHg with a maximum dose of 3 mcg.Kg-1]
Measured: Intraoperative
Secondary outcomes (1)
Average category scale (ACS)
The surgeon will be asked, at the end of surgery, to assess bleeding in the surgical field using the average category scale 0-5 scale where [0=No bleeding and5=Severe bleeding]
Measured: Intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2018
- Study start28 Nov 2018
- Primary completionFeb 2019 (estimated)
- Study completionMar 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypotensive AnesthesiaStudies of the same condition, open and under way.
- More trials run by Ain Shams 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 N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hanan Mahmoud Farag Awad, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03774693
- Sponsor's protocol ID
- FMASU R66/2018
- Status last verified
- Dec 2018
- First submitted
- 11 Dec 2018
- Last updated
- 17 Dec 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Regional Block of the Nose in Achieving Hypotensive Anaesthesia in Septo-rhinoplasty Surgery
- ClinicalTrials.gov ID
- NCT03774693
- Acronym / sponsor ID
- FMASU R66/2018
- Conditions
- Hypotensive Anesthesia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 28 Nov 2018 (actual)
- Primary completion
- Feb 2019 (estimated)
- Study completion
- Mar 2019 (estimated)
- First posted
- 13 Dec 2018 (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.
Septorhinoplasty is a cosmetic surgery that many people are choosing to undergo. It can be done under general anesthesia, twilight anesthesia or regional anesthesia. Controlled hypotensive anesthesia is required to minimize bruising, swelling, and bleeding that reduces visibility in the operative field and hence satisfactory surgical outcome.
The goal of our study to prove that regional block of the nose provides efficient hypotensive anesthesia
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GS [General anesthesia] | Active comparator | Other: General anesthesia with fentanyl bolusesPatients will receive general anesthesia with Fentanyl boluses of 0.5 mcg.Kg-1 given to maintain MAP between 55-65 mmHg with a maximum dose of 3 mcg.Kg-1. |
| GR [General anesthesia + regional block] | Active comparator | Other: General anesthesia with fentanyl boluses, Procedure: Regional blockPatients will receive general anesthesia with Fentanyl boluses of 0.5 mcg.Kg-1 given to maintain MAP between 55-65 mmHg with a maximum dose of 3 mcg.Kg-1. Also patients will receive trans-oral bilateral sphenopalatine ganglion block and trans-oral bilateral infraorbital nerve block. Fentanyl boluses of 0.5 mcg.Kg-1 will be given when needed to maintain MAP between 55-65 mmHg with a maximum dose of 3 mcg.Kg-1. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- American Society of Anesthesiologists (ASA) physical status I-II
- Scheduled for elective septo-rhinoplasty surgery
Key exclusion criteria (4 listed)
- Patients with hypertension or coronary artery disease,
- Patients with renal, hepatic or cerebral insufficiency,
- Patients with coagulopathy or receiving drugs influencing blood coagulation,
- Patients with known sensitivity to any of the study drug
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 |
|---|---|---|
| General anesthesia with fentanyl bolusesPatients will receive general anesthesia with Fentanyl boluses of 0.5 mcg.Kg-1 given to maintain MAP between 55-65 mmHg with a maximum dose of 3 mcg.Kg-1 | Other | GR [General anesthesia + regional block], GS [General anesthesia] |
| Regional blockPatients will receive trans-oral bilateral sphenopalatine ganglion block and trans-oral bilateral infraorbital nerve block. | Procedure or surgery | GR [General anesthesia + regional block] |
Primary outcome
Hypotensive anesthesia
Time frame: Intraoperative
Measurement of Mean arterial blood pressure
Requirements of Fentanyl
Time frame: Intraoperative
Assessment of intraoperative fentanyl doses of [Fentanyl boluses of 0.5 mcg.Kg-1 will be given to maintain mean arterial pressure (MAP) between 55-65 mmHg with a maximum dose of 3 mcg.Kg-1]
1 secondary outcome
Average category scale (ACS)
Time frame: Intraoperative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2018.
- Individual participant dataSharing planned: Undecided
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Effect of the Superficial Cervical Plexus Block in the Hypotensive Anesthesia of Ear Surgery.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing General anesthesia with fentanyl boluses and Regional block in people with Hypotensive Anesthesia, run by Ain Shams University at 1 site in Egypt.
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 2 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 17 Dec 2018. 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 Egypt. 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?
Results are not available in the source record.
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?
Hypotensive anesthesia (time frame: Intraoperative). 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 17 Dec 2018.