Deviation Septum NasalPhase 4NCT01752959
A Comparison of Esmolol and Remifentanil to Reduce Blood Loss
A Phase 4 study testing Remifentanil and Esmolol in people with Deviation Septum Nasal, run by Diskapi Teaching and Research Hospital at 2 sites in Turkey (Türkiye).
Trial summary
In this prospective randomized study we aimed to compare the effects of esmolol and remifentanil on intraoperative bleeding surgical field conditions in nasal surgery Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Deviation Septum Nasal
- What is being tested?
- Remifentanil and Esmolol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- Jul 2012to Dec 2012
- Phase
- Phase 4
- 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 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- ASA I-II,
- between age 20-60
Who cannot join
- patients having bleeding disorders,
- arrhythmia,
- hypertension,
- endocrine, liver or kidney disease and
- those who are on antihypertensive,
- anticoagulant drugs
Trial locations and contacts
2 sites in 1 country.
Ruveyda D Acikgoz, Trainee contact
Turkey (Türkiye)2 sites, 1 recruiting
- Completed
Diskapi Yildirim Beyazit Training and Research Hospital
Ankara, 06110
- Recruiting
Diskapi Yildirim Beyazit Training and Research Hospital
Ankara, 06610
Murat Alper, Proffesor, 03125962242, muratalper@hotmail.com
About this study
Official title: A Randomized Comparison of Esmolol and Remifentanil on Intraoperative Bleeding and Surgical Field Conditionsin Nasal Surgery
In this prospective randomized study we aimed to compare the effects of esmolol and remifentanil on intraoperative bleeding surgical field conditions in nasal surgery
Read the detailed description
60 patients with ASA I-IIphysical status assigned for septoplasty will be enrolled in this prospective randomized trial. A standardized anesthesia induction and intubation with propofol and rocuronium will be used. Patients will be randomized in two groups. Group Esmolol (Group E n=30) will receive esmolol 500 mic kg-1 loading dose and a 50-500 mic kg-1 min-1 infusion and Group Remifentanil (Group R n=30) will receive remifentanil 0.1-0.3 mic kg-1 min-1 infusion to induce controlled hypotension. A 50-60 mmHg mean arterial pressure and a minimum 50 beat min-1 heart rate is targeted. Heart rate, blood pressures, peripheral oxygen saturation and bispectral index spectrum (BIS) will be recorded. Anesthesia maintenance will be provided with O2/N2O and desflurane-propofol balanced anesthesia and a BIS value 40-60 is targeted. The quality of the surgical field will be assessed by the surgeon by using a 10 point visual analog scale (B1) and a 6 point scale (B2) during surgery with 5 minute intervals. The amount of bleeding will be calculated at the end of surgery from the amount of blood and irrigation fluid collected in the suction tube. All complications and side effects will be recorded.
- Conditions
- Deviation Septum Nasal
- Being tested
- Remifentanil, Esmolol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RemifentanilDrug
Also called Ultiva
0.1-0.3 micg/kg/min Remifentanil iv infusion
EsmololDrug
Also called Brevibloc
500 μcg/kg/dk esmolol iv lading dose after 50-500 μcg/kg/dk esmolol iv infusion
| Study group | Role | What they receive |
|---|---|---|
| Remifentanyl | Active comparator | Group R 0.1-0.3 mic/kg/ min remifentanil infusion other names: Ultiva Receives: Drug: Remifentanil |
| esmolol | Experimental | Grup E 500 micg/kg/min lading dose after 50-500 μcg/kg/dk esmolol infusion Receives: Drug: Esmolol |
What is being measured
The primary outcome is the main question the study is designed to answer.
the difference between group regarding blood loss
controlled hypotension in nasal surgery
Measured: intraoperative
Secondary outcomes (1)
the difference between groups regarding side effects and treatments
side effects: more than 20% change in blood pressure and heart rate, treatment includes atropin, ephedrin, nitroglyserine
Measured: intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2012 (estimated)
- Study startJul 2012
- Primary completionDec 2012 (estimated)
- Study completionDec 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Deviation Septum NasalStudies 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 4
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Diskapi Teaching and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dondu Ruveyda Acikgoz, Diskapi Teaching and Research Hospital
- Investigators
- Ruveyda D Acıkgoz, Trainee, Principal investigator, Ankara Diskapi Yildirim Beyazit Teaching and Research Hospital, Turkey.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01752959
- Sponsor's protocol ID
- RAcikgozEsmolol
- Status last verified
- Dec 2012
- First submitted
- 4 Dec 2012
- Last updated
- 19 Dec 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Degoute CS, Ray MJ, Manchon M, Dubreuil C, Banssillon V. Remifentanil and controlled hypotension; comparison with nitroprusside or esmolol during tympanoplasty. Can J Anaesth. 2001 Jan;48(1):20-7. doi: 10.1007/BF03019809.
PubMed 11212044Shen PH, Weitzel EK, Lai JT, Wormald PJ, Ho CS. Intravenous esmolol infusion improves surgical fields during sevoflurane-anesthetized endoscopic sinus surgery: a double-blind, randomized, placebo-controlled trial. Am J Rhinol Allergy. 2011 Nov-Dec;25(6):e208-11. doi: 10.2500/ajra.2011.25.3701.
PubMed 22185726
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Comparison of Esmolol and Remifentanil on Intraoperative Bleeding and Surgical Field Conditionsin Nasal Surgery
- ClinicalTrials.gov ID
- NCT01752959
- Acronym / sponsor ID
- RAcikgozEsmolol
- Conditions
- Deviation Septum Nasal
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Diskapi Teaching and Research HospitalUniversity, hospital or other
- Study start
- Jul 2012
- Primary completion
- Dec 2012 (estimated)
- Study completion
- Dec 2012 (estimated)
- First posted
- 19 Dec 2012 (estimated)
- 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.
In this prospective randomized study we aimed to compare the effects of esmolol and remifentanil on intraoperative bleeding surgical field conditions in nasal surgery
Detailed description
60 patients with ASA I-IIphysical status assigned for septoplasty will be enrolled in this prospective randomized trial. A standardized anesthesia induction and intubation with propofol and rocuronium will be used. Patients will be randomized in two groups. Group Esmolol (Group E n=30) will receive esmolol 500 mic kg-1 loading dose and a 50-500 mic kg-1 min-1 infusion and Group Remifentanil (Group R n=30) will receive remifentanil 0.1-0.3 mic kg-1 min-1 infusion to induce controlled hypotension. A 50-60 mmHg mean arterial pressure and a minimum 50 beat min-1 heart rate is targeted. Heart rate, blood pressures, peripheral oxygen saturation and bispectral index spectrum (BIS) will be recorded. Anesthesia maintenance will be provided with O2/N2O and desflurane-propofol balanced anesthesia and a BIS value 40-60 is targeted. The quality of the surgical field will be assessed by the surgeon by using a 10 point visual analog scale (B1) and a 6 point scale (B2) during surgery with 5 minute intervals. The amount of bleeding will be calculated at the end of surgery from the amount of blood and irrigation fluid collected in the suction tube. All complications and side effects will be recorded.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Remifentanyl | Active comparator | Drug: RemifentanilGroup R 0.1-0.3 mic/kg/ min remifentanil infusion other names: Ultiva |
| esmolol | Experimental | Drug: EsmololGrup E 500 micg/kg/min lading dose after 50-500 μcg/kg/dk esmolol infusion |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- ASA I-II,
- between age 20-60
Key exclusion criteria (6 listed)
- patients having bleeding disorders,
- arrhythmia,
- hypertension,
- endocrine, liver or kidney disease and
- those who are on antihypertensive,
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 |
|---|---|---|
| RemifentanilAlso: Ultiva0.1-0.3 micg/kg/min Remifentanil iv infusion | Drug | Remifentanyl |
| EsmololAlso: Brevibloc500 μcg/kg/dk esmolol iv lading dose after 50-500 μcg/kg/dk esmolol iv infusion | Drug | esmolol |
Primary outcome
the difference between group regarding blood loss
Time frame: intraoperative
controlled hypotension in nasal surgery
1 secondary outcome
the difference between groups regarding side effects and treatments
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 19 Dec 2012.
- Background: PubMed 11212044Degoute CS, Ray MJ, Manchon M, Dubreuil C, Banssillon V. Remifentanil and controlled hypotension; comparison with nitroprusside or esmolol during tympanoplasty. Can J Anaesth. 2001 Jan;48(1):20-7. doi: 10.1007/BF03019809.
- Background: PubMed 22185726Shen PH, Weitzel EK, Lai JT, Wormald PJ, Ho CS. Intravenous esmolol infusion improves surgical fields during sevoflurane-anesthetized endoscopic sinus surgery: a double-blind, randomized, placebo-controlled trial. Am J Rhinol Allergy. 2011 Nov-Dec;25(6):e208-11. doi: 10.2500/ajra.2011.25.3701.
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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.
Ruveyda D Acikgoz, Trainee contact
Ruveyda D Acıkgoz, Trainee principal investigator
Ankara Diskapi Yildirim Beyazit Teaching and Research Hospital, Turkey.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Remifentanil and Esmolol in people with Deviation Septum Nasal, run by Diskapi Teaching and Research Hospital at 2 sites in Turkey (Türkiye).
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 6 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 19 Dec 2012. 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 Turkey (Türkiye). 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Contact Ruveyda D Acikgoz, Trainee (0903125962554), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the difference between group regarding blood loss (time frame: intraoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01752959, which also lists 2 linked publications.
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 19 Dec 2012.