Hemodynamic InstabilityPhase 4NCT02464722
Comparision Between Hemodynamic Response of Dexmedetomidine and Remifentanil on Anesthesia in Endoscopic Sinus Surgery
A Phase 4 study testing Dexmedetomidine, Remifentanil and Epinephrine in people with Hemodynamic Instability, run by Korea University Anam Hospital.
Trial summary
During endoscopic sinus surgery (ESS), epinephrine local injection and controlled hypotension is essential in order to increase the visibility in the operative field and reduce the risk. This study is comparing of dexmedetomidine and remifentanil before epinephrine local injection for controlled hypotension during ESS. Read more about this study
- Who is it for?
- Ages 20 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Hemodynamic Instability
- What is being tested?
- Dexmedetomidine, Remifentanil and Epinephrine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Aug 2015to Sep 2016
- 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
- Healthy volunteers accepted
- Adult
Who may be able to join
- American Society of Anesthesiologist[ASA] class 1-2
- scheduled Endoscopic sinus surgery
- written informed consent
Who cannot join
- allergy of opioids, neuromuscular blocking drugs or other medications used during general anesthesia
- known or suspected upper respiratory infection
- suspected difficult tracheal intubation
- Uncontrolled Hypertension
- known or suspected psychologic disorder
- known or suspected significant renal dysfunction
- known or suspected severe hepatic dysfunction
- known or suspected significant cardiovascular dysfunction
About this study
Official title: Comparision Between Hemodynamic Response of Dexmedetomidine and Remifentanil for Epinephrine Local Injection in Patient With Endoscopic Sinus Surgery Under General Anesthesia
During endoscopic sinus surgery (ESS), epinephrine local injection and controlled hypotension is essential in order to increase the visibility in the operative field and reduce the risk. This study is comparing of dexmedetomidine and remifentanil before epinephrine local injection for controlled hypotension during ESS.
Read the detailed description
During endoscopic sinus surgery (ESS), epinephrine local injection and controlled hypotension is essential in order to increase the visibility in the operative field and reduce the risk.
Epinephrine local injection and controlled hypotensive anesthesia is commonly used in several surgical interventions using different techniques. However, choosing the ideal agent is still a controversial topic.
In the current study, the effects and safety of remifentanil, which is an μ opioid receptor agonist and dexmedetomidine, an α-2 agonist; when used before epinephrine local injection for controlled hypotension in ESS, are compared.
After obtaining Institutional Review Board approval and written informed consent, 40 patients is enrolling in this study.
Participants is divided by two groups randomly as the Dexmedetomidine group and the Remifentanil group.
A correctly sized facemask and 100 % oxygen was used for pre-oxygenation. General anesthesia was induced with iv Propofol 1.5-2 mg kg-1. Endotracheal intubation was performed with the aid of iv Rocuronium 0.6 kg-1. Ventilation was controlled with 50% air in oxygen to maintain end-tidal carbon dioxide pressure at 30-36 mmHg. Desflurane was used for maintenance.
Before epinephrine injection, In group Remifentanil, Participants received 1 mcg kg-1 iv loading dose of remifentanil over a period of 60 seconds. Later, an infusion was started at the rate of 0.2-0.4 mcg kg-1 h-1. The infusion rate was adjusted according to the Participants response, to achieve a mean arterial pressure between 60 and 75 mmHg. In group Dexmedetomidine, patients received a 1 mcg kg-1 loading dosage of dexmedetomidine within 10 min and later, infusion was started at the rate of 0.4-0.8 mcg kg-1min-1. The infusions began before tracheal intubation in both groups. Standard dose epinephrine local infiltration was administered to the nasal passages by the surgeon.
Systolic Arterial Pressure,Diastolic Arterial Pressure,Mean arterial blood pressure, Heart Rate were recorded every 5min, from the beginning of anesthesia and every 1min, from the epinephrine local injection. Perioperative hypotension and bradycardia were defined as mean arterial blood pressure < 50 mmHg or 50 beat/min respectively. Ephedine was administered intravenously for the treatment of hypotension. Atropine 0.5 mg was administered intravenously for the treatment of bradycardia.
All infusions were stopped 5 min before the end of surgery. After surgery, the surgeon evaluated the dryness of the surgical area. Recovery time was recorded in the postoperative period. An investigators employing the Modified Observer's Assessment of Alertness/Sedation Scale assessed recovery.
- Conditions
- Hemodynamic Instability
- Being tested
- Dexmedetomidine, Remifentanil, Epinephrine, Propofol, Rocuronium
- Keywords
- Remifentanil, Dexmedetomidine, Endoscopic sinus surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
Also called dexmedetomidine hydrochloride
1 mcg/kg iv loading dose of remifentanil over a period of 60 seconds. Later, an infusion was started at the rate of 0.2-0.4mcg/kg/min.
RemifentanilDrug
Also called remifentanil hydrochloride
1 mcg/kg iv loading dose of remifentanil over a period of 10 minutes. Later, an infusion was started at the rate of 0.4-0.8mcg/kg/min.
EpinephrineDrug
Before the start of surgery, 1/100000 epinephrine infiltration was administered to the nasal passages by the surgeon.
PropofolDrug
Anesthesia was induced with propofol 2 mg kg-1
RocuroniumDrug
Anesthesia was induced with rocuronium 0.6 mg kg-1
| Study group | Role | What they receive |
|---|---|---|
| Dexmedetomidine | Experimental | 1. Before induction of Anesthesia, 1 mcg/kg iv loading dose of dexmedetomidine over 10 minutes.
2. Anesthesia was induced with propofol 2 mg kg-1 , rocuronium 0.6 mg kg-1
3. After Mask ventilation with 6 vol% desflurane in 100% oxygen for 3 minutes, tracheal intubation was done
4. Later, an infusion was started at the rate of 0.4-0.8mcg/kg/min. The infusion rate was adjusted according to the patient's response, to achieve a mean arterial pressure between 60 and 80 mmHg.
5. Before the start of surgery, 1/100000 epinephrine infiltration was administered to the nasal passages by the surgeon.
6. At the end of surgery, discontinuation of desflurane and dexmedetomidine, sending recovery room. Receives: Drug: Dexmedetomidine; Drug: Epinephrine; Drug: Propofol; Drug: Rocuronium |
| Remifentanil | Active comparator | 1. Anesthesia was induced with propofol 2 mg kg-1 , rocuronium 0.6 mg kg-1
2. Mask ventilation with 6 vol% desflurane in 100% oxygen for 2 minutes.
3. After 1 mcg/kg iv loading dose of remifentanil over a period of 1 minutes. tracheal intubation was done.
4. Later, an infusion was started at the rate of 0.2-0.4mcg/kg/min. The infusion rate was adjusted according to the patient's response, to achieve a mean arterial pressure between 60 and 80 mmHg.
5. Before the start of surgery, 1/100000 epinephrine infiltration was administered to the nasal passages by the surgeon.
6. At the end of surgery, discontinuation of desflurane and remifentanil, sending recovery room. Receives: Drug: Remifentanil; Drug: Epinephrine; Drug: Propofol; Drug: Rocuronium |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in blood pressure
Measured: At the time from epinephrine local injection (1,2,3,4,5,6,7,8,9,10,11,12,13,14,15 minutes)
Secondary outcomes (1)
Conditions during Surgery
We assessed conditions during ESS(Surgeon evaluated the dryness of the surgical area using six point quality scale.)
Measured: At the time during Surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2015 (estimated)
- Study startAug 2015
- Primary completionNov 2015 (estimated)
- Study completionSep 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hemodynamic InstabilityStudies 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
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Korea University Anam Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joonchul Jang, Korea University Anam Hospital
- Investigators
- Jangeun Cho, M.D, Ph.D, Principal investigator, Anesthesia and Pain medicine department, Korea University Anam Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02464722
- Sponsor's protocol ID
- ED15010
- Status last verified
- Jul 2015
- First submitted
- 27 May 2015
- Last updated
- 27 Jul 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Lee J, Kim Y, Park C, Jeon Y, Kim D, Joo J, Kang H. Comparison between dexmedetomidine and remifentanil for controlled hypotension and recovery in endoscopic sinus surgery. Ann Otol Rhinol Laryngol. 2013 Jul;122(7):421-6. doi: 10.1177/000348941312200702.
PubMed 23951692
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparision Between Hemodynamic Response of Dexmedetomidine and Remifentanil for Epinephrine Local Injection in Patient With Endoscopic Sinus Surgery Under General Anesthesia
- ClinicalTrials.gov ID
- NCT02464722
- Acronym / sponsor ID
- ED15010
- Conditions
- Hemodynamic Instability
- Keywords
- Remifentanil, Dexmedetomidine, Endoscopic sinus surgery
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Korea University Anam HospitalUniversity, hospital or other
- Study start
- Aug 2015
- Primary completion
- Nov 2015 (estimated)
- Study completion
- Sep 2016 (estimated)
- First posted
- 8 Jun 2015 (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.
During endoscopic sinus surgery (ESS), epinephrine local injection and controlled hypotension is essential in order to increase the visibility in the operative field and reduce the risk. This study is comparing of dexmedetomidine and remifentanil before epinephrine local injection for controlled hypotension during ESS.
Detailed description
During endoscopic sinus surgery (ESS), epinephrine local injection and controlled hypotension is essential in order to increase the visibility in the operative field and reduce the risk.
Epinephrine local injection and controlled hypotensive anesthesia is commonly used in several surgical interventions using different techniques. However, choosing the ideal agent is still a controversial topic.
In the current study, the effects and safety of remifentanil, which is an μ opioid receptor agonist and dexmedetomidine, an α-2 agonist; when used before epinephrine local injection for controlled hypotension in ESS, are compared.
After obtaining Institutional Review Board approval and written informed consent, 40 patients is enrolling in this study.
Participants is divided by two groups randomly as the Dexmedetomidine group and the Remifentanil group.
A correctly sized facemask and 100 % oxygen was used for pre-oxygenation. General anesthesia was induced with iv Propofol 1.5-2 mg kg-1. Endotracheal intubation was performed with the aid of iv Rocuronium 0.6 kg-1. Ventilation was controlled with 50% air in oxygen to maintain end-tidal carbon dioxide pressure at 30-36 mmHg. Desflurane was used for maintenance.
Before epinephrine injection, In group Remifentanil, Participants received 1 mcg kg-1 iv loading dose of remifentanil over a period of 60 seconds. Later, an infusion was started at the rate of 0.2-0.4 mcg kg-1 h-1. The infusion rate was adjusted according to the Participants response, to achieve a mean arterial pressure between 60 and 75 mmHg. In group Dexmedetomidine, patients received a 1 mcg kg-1 loading dosage of dexmedetomidine within 10 min and later, infusion was started at the rate of 0.4-0.8 mcg kg-1min-1. The infusions began before tracheal intubation in both groups. Standard dose epinephrine local infiltration was administered to the nasal passages by the surgeon.
Systolic Arterial Pressure,Diastolic Arterial Pressure,Mean arterial blood pressure, Heart Rate were recorded every 5min, from the beginning of anesthesia and every 1min, from the epinephrine local injection. Perioperative hypotension and bradycardia were defined as mean arterial blood pressure < 50 mmHg or 50 beat/min respectively. Ephedine was administered intravenously for the treatment of hypotension. Atropine 0.5 mg was administered intravenously for the treatment of bradycardia.
All infusions were stopped 5 min before the end of surgery. After surgery, the surgeon evaluated the dryness of the surgical area. Recovery time was recorded in the postoperative period. An investigators employing the Modified Observer's Assessment of Alertness/Sedation Scale assessed recovery.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dexmedetomidine | Experimental | Drug: Dexmedetomidine, Drug: Epinephrine, Drug: Propofol, Drug: Rocuronium1. Before induction of Anesthesia, 1 mcg/kg iv loading dose of dexmedetomidine over 10 minutes. 2. Anesthesia was induced with propofol 2 mg kg-1 , rocuronium 0.6 mg kg-1 3. After Mask ventilation with 6 vol% desflurane in 100% oxygen for 3 minutes, tracheal intubation was done 4. Later, an infusion was started at the rate of 0.4-0.8mcg/kg/min. The infusion rate was adjusted according to the patient's response, to achieve a mean arterial pressure between 60 and 80 mmHg. 5. Before the start of surgery, 1/100000 epinephrine infiltration was administered to the nasal passages by the surgeon. 6. At the end of surgery, discontinuation of desflurane and dexmedetomidine, sending recovery room. |
| Remifentanil | Active comparator | Drug: Remifentanil, Drug: Epinephrine, Drug: Propofol, Drug: Rocuronium1. Anesthesia was induced with propofol 2 mg kg-1 , rocuronium 0.6 mg kg-1 2. Mask ventilation with 6 vol% desflurane in 100% oxygen for 2 minutes. 3. After 1 mcg/kg iv loading dose of remifentanil over a period of 1 minutes. tracheal intubation was done. 4. Later, an infusion was started at the rate of 0.2-0.4mcg/kg/min. The infusion rate was adjusted according to the patient's response, to achieve a mean arterial pressure between 60 and 80 mmHg. 5. Before the start of surgery, 1/100000 epinephrine infiltration was administered to the nasal passages by the surgeon. 6. At the end of surgery, discontinuation of desflurane and remifentanil, sending recovery room. |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- American Society of Anesthesiologist[ASA] class 1-2
- scheduled Endoscopic sinus surgery
- written informed consent
Key exclusion criteria (8 listed)
- allergy of opioids, neuromuscular blocking drugs or other medications used during general anesthesia
- known or suspected upper respiratory infection
- suspected difficult tracheal intubation
- Uncontrolled Hypertension
- known or suspected psychologic disorder
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: dexmedetomidine hydrochloride1 mcg/kg iv loading dose of remifentanil over a period of 60 seconds. Later, an infusion was started at the rate of 0.2-0.4mcg/kg/min. | Drug | Dexmedetomidine |
| RemifentanilAlso: remifentanil hydrochloride1 mcg/kg iv loading dose of remifentanil over a period of 10 minutes. Later, an infusion was started at the rate of 0.4-0.8mcg/kg/min. | Drug | Remifentanil |
| EpinephrineBefore the start of surgery, 1/100000 epinephrine infiltration was administered to the nasal passages by the surgeon. | Drug | Dexmedetomidine, Remifentanil |
| PropofolAnesthesia was induced with propofol 2 mg kg-1 | Drug | Dexmedetomidine, Remifentanil |
| RocuroniumAnesthesia was induced with rocuronium 0.6 mg kg-1 | Drug | Dexmedetomidine, Remifentanil |
Primary outcome
Change in blood pressure
Time frame: At the time from epinephrine local injection (1,2,3,4,5,6,7,8,9,10,11,12,13,14,15 minutes)
1 secondary outcome
Conditions during Surgery
Time frame: At the time during Surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2015.
- Results publication: PubMed 23951692Lee J, Kim Y, Park C, Jeon Y, Kim D, Joo J, Kang H. Comparison between dexmedetomidine and remifentanil for controlled hypotension and recovery in endoscopic sinus surgery. Ann Otol Rhinol Laryngol. 2013 Jul;122(7):421-6. doi: 10.1177/000348941312200702.
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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.
Jangeun Cho, M.D, Ph.D principal investigator
Anesthesia and Pain medicine department, Korea University Anam Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dexmedetomidine, Remifentanil and Epinephrine in people with Hemodynamic Instability, run by Korea University Anam Hospital.
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 8 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 27 Jul 2015. 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?
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?
Change in blood pressure (time frame: At the time from epinephrine local injection (1,2,3,4,5,6,7,8,9,10,11,12,13,14,15 minutes)). 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 NCT02464722, which also lists 1 linked publication.
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 27 Jul 2015.