SurgeryPhase 4NCT01964586
Comparison of Preincisional Infiltrated Dexmedetomidine and Lidocaine Plus Adrenaline for Nasal Sephoplasty Surgery.
A Phase 4 study testing Dexmedetomidine, Lidocaine and Adrenaline in people with Surgery and Pain, run by TC Erciyes University.
Trial summary
It is very important to decrease the bleeding during nasal septoplasty in order to increase the visibility of the surgical site. Our primary goal was to investigate the effects of dexmedetomidine and lidocaine plus adrenaline on visibility of surgical site and postoperative analgesic consumption. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- What is being tested?
- Dexmedetomidine, Lidocaine and Adrenaline
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Mar 2013to Oct 2013
- 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Scheduled for the nasal septoplasty surgery
- ASA 1-2 patients
- 18-60 yo patients
Who cannot join
- Pregnant patients
- ASA 3-4 patients
- Under 18 yo childrens
About this study
Official title: Phase 4 Study of Comparison of Preincisional Infiltrated Dexmedetomidine and Lidocaine Plus Adrenaline for Surgical Conditions and Postoperative Analgesic Consumption in Nasal Sephoplasty Surgery.
It is very important to decrease the bleeding during nasal septoplasty in order to increase the visibility of the surgical site. Our primary goal was to investigate the effects of dexmedetomidine and lidocaine plus adrenaline on visibility of surgical site and postoperative analgesic consumption.
Read the detailed description
Nasal septoplasty is a surgery procedure which needs to have decrease the bleeding during the surgery for the visibility of surgical site.And postoperative pain is very usual after the surgery, so an effective postoperative analgesia procedure reduces the complications and helps to be discharged earlier from the hospital. An alpha 2 agonist Dexmedetomidine has an analgesic effect and vasoconstructive effect on the periferal blood vessels. Our hypothesis was dexmedetomidine makes a better surgecal conditions during the surgery and reduce the postoperative analgesic consumption. We administered the infiltrated dexmedetomidine or lidocaine plus adrenaline to the both side of the nasal septum 10 minutes before the surgery. Bleeding scores (Fromm and Boezaart Bleeding Scores) were recorded during the surgery. And postoperative analgesic consumptions were recorded in first 24 hours after the surgery.
- Being tested
- Dexmedetomidine, Lidocaine, Adrenaline
- Keywords
- Septoplasty, Dexmedetomidine, Surgical Conditions
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
Also called Precedex
2 mcg/kg dexmedetomidine was administered 10 minutes before the surgery by infiltration to the both side of the nasal septum.
LidocaineDrug
Also called Jetokain %2
10 ml 2% lidocaine was administered 10 minutes before the surgery by infiltration to the both side of the nasal septum.
AdrenalineDrug
Also called Adrenalin, Epinefrin
12.5 mcg/ml 10 ml adrenaline was administered 10 minutes before the surgery by infiltration to the both side of the nasal septum.
| Study group | Role | What they receive |
|---|---|---|
| Lidocaine plus Adrenaline | Active comparator | Lidocaine and adrenaline diluted to 10 ml with normal salin and infiltrated to both side of the nasal septum before 10 minutes from the surgery. Receives: Drug: Lidocaine; Drug: Adrenaline |
| Dexmedetomidine | Active comparator | 2 mcg/kg dexmedetomidine diluted to 10 ml with normal salin and infiltrated to both side of the nasal septum before 10 minutes the surgery. Receives: Drug: Dexmedetomidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
surgical conditions
Bleeding scores were recorded during the surgery
Measured: during the surgery
Secondary outcomes (1)
Analgesic Consumption
Analgesic consumption were recorded.
Measured: Up to 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2013 (estimated)
- Study startMar 2013
- Primary completionSep 2013
- Study completionOct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SurgeryStudies of the same condition, open and under way.
- More trials run by TC Erciyes 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- TC Erciyes University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Adnan Bayram, TC Erciyes University
- Investigators
- Adnan Bayram, MD, Principal investigator, TC Erciyes University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01964586
- Sponsor's protocol ID
- 2013/167
- Status last verified
- Oct 2013
- First submitted
- 15 Oct 2013
- Last updated
- 17 Oct 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 4 Study of Comparison of Preincisional Infiltrated Dexmedetomidine and Lidocaine Plus Adrenaline for Surgical Conditions and Postoperative Analgesic Consumption in Nasal Sephoplasty Surgery.
- ClinicalTrials.gov ID
- NCT01964586
- Acronym / sponsor ID
- 2013/167
- Keywords
- Septoplasty, Dexmedetomidine, Surgical Conditions
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- TC Erciyes UniversityUniversity, hospital or other
- Study start
- Mar 2013
- Primary completion
- Sep 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 17 Oct 2013 (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.
It is very important to decrease the bleeding during nasal septoplasty in order to increase the visibility of the surgical site. Our primary goal was to investigate the effects of dexmedetomidine and lidocaine plus adrenaline on visibility of surgical site and postoperative analgesic consumption.
Detailed description
Nasal septoplasty is a surgery procedure which needs to have decrease the bleeding during the surgery for the visibility of surgical site.And postoperative pain is very usual after the surgery, so an effective postoperative analgesia procedure reduces the complications and helps to be discharged earlier from the hospital. An alpha 2 agonist Dexmedetomidine has an analgesic effect and vasoconstructive effect on the periferal blood vessels. Our hypothesis was dexmedetomidine makes a better surgecal conditions during the surgery and reduce the postoperative analgesic consumption. We administered the infiltrated dexmedetomidine or lidocaine plus adrenaline to the both side of the nasal septum 10 minutes before the surgery. Bleeding scores (Fromm and Boezaart Bleeding Scores) were recorded during the surgery. And postoperative analgesic consumptions were recorded in first 24 hours after the surgery.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lidocaine plus Adrenaline | Active comparator | Drug: Lidocaine, Drug: AdrenalineLidocaine and adrenaline diluted to 10 ml with normal salin and infiltrated to both side of the nasal septum before 10 minutes from the surgery. |
| Dexmedetomidine | Active comparator | Drug: Dexmedetomidine2 mcg/kg dexmedetomidine diluted to 10 ml with normal salin and infiltrated to both side of the nasal septum before 10 minutes the surgery. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Scheduled for the nasal septoplasty surgery
- ASA 1-2 patients
- 18-60 yo patients
Key exclusion criteria (3 listed)
- Pregnant patients
- ASA 3-4 patients
- Under 18 yo childrens
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 |
|---|---|---|
| DexmedetomidineAlso: Precedex2 mcg/kg dexmedetomidine was administered 10 minutes before the surgery by infiltration to the both side of the nasal septum. | Drug | Dexmedetomidine |
| LidocaineAlso: Jetokain %210 ml 2% lidocaine was administered 10 minutes before the surgery by infiltration to the both side of the nasal septum. | Drug | Lidocaine plus Adrenaline |
| AdrenalineAlso: Adrenalin, Epinefrin12.5 mcg/ml 10 ml adrenaline was administered 10 minutes before the surgery by infiltration to the both side of the nasal septum. | Drug | Lidocaine plus Adrenaline |
Primary outcome
surgical conditions
Time frame: during the surgery
Bleeding scores were recorded during the surgery
1 secondary outcome
Analgesic Consumption
Time frame: Up to 24 hours
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 17 Oct 2013.
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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.
Adnan Bayram, MD principal investigator
TC Erciyes University
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dexmedetomidine, Lidocaine and Adrenaline in people with Surgery and Pain, run by TC Erciyes 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 3 inclusion and 3 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 17 Oct 2013. 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?
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?
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?
surgical conditions (time frame: during the surgery). 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 Oct 2013.