Robotic ThyroidectomyPhase 4DXM_HydroNCT02102139
Preop Dexmedetomidine Attenuates Haemodynamic Responses to Hydrodissection
A Phase 4 study testing DXM + Propofol and Saline + Propofol in people with Robotic Thyroidectomy, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
Percutaneous tunnelling (hydrodissection) in the neck and anterior chest in patients undergoing robotic thyroidectomy leads to significant haemodynamic responses such as increases in blood pressure and heart rate. Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Robotic Thyroidectomy
- What is being tested?
- DXM + Propofol and Saline + Propofol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 41 participants
- Where
- 1 siteSouth Korea
- Study dates
- May 2012to Sep 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA physical status I-II patientsscheduled for general anaesthesia for robotic thyroidectomy
Who cannot join
- Patients with an allergy to α2-adrenergic agonists or propofol
- Patients with current antihypertensive medication
- Patients with heart block > 1 degree
- Patients with severe cardiorespiratory dysfunction
- Patients with history of alcohol or drug abuse
- Patients who had received an opioid analgesic medication within the previous 24-h period before the operation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single Preoperative Injection of Dexmedetomidine Attenuates Haemodynamic Responses to Hydrodissection in Patients Undergoing Robotic Thyroidectomy: a Prospective Randomised Double-blinded Study
Percutaneous tunnelling (hydrodissection) in the neck and anterior chest in patients undergoing robotic thyroidectomy leads to significant haemodynamic responses such as increases in blood pressure and heart rate. The investigators evaluated whether a single preoperative dexmedetomidine injection attenuated the haemodynamic responses to hydrodissection by reducing the half-maximal effective concentration (EC50) of remifentanil needed to maintain haemodynamic stability during hydrodissection.
Read the detailed description
Dexmedetomidine (DXM) is a recently released and approved alpha 2 agonist with a relatively high ratio of α2/α1-activity and an almost fourfold shorter half-life than clonidine.It's sympatholytic, sedative, and analgesic properties makes DXM a useful anaesthetic adjuvant for general anaesthesia. While there are some reports of the beneficial effects of DXM on anaesthetic requirements and haemodynamic responses to endotracheal intubation, the effect of a single preoperative injection of DXM in terms of attenuating haemodymanic responses to surgical stimulation in robot-assisted thyroidectomy is unknown.
When a robotic thyroidectomy using the bilateral axillary breast approach (BABA) technique is performed, subcutaneous tunnelling in the neck and anterior chest, which is defined as hydrodissection, is mandatory. Unfortunately, the procedure leads to significant haemodynamic responses, such as increases in blood pressure and heart rate.
We hypothesised that preoperative DXM administration would attenuate the haemodynamic responses to hydrodissection. This study was designed to evaluate the effects of a single preoperative administration of DXM on haemodynamic responses to hydrodissection in robotic thyroidectomy by comparing the half-maximal effective concentration (EC50) of remifentanil needed to maintain haemodynamic stability during hydrodissection between DXM and control groups. We also investigated the effects of preoperative DXM administration on total doses of remifentanil and propofol administered intraoperatively.
- Conditions
- Robotic Thyroidectomy
- Being tested
- DXM + Propofol, Saline + Propofol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DXM + PropofolDrug
After induction as mentioned at 'arm description', the effect-site propofol concentration was fixed at 5.0 μg mL-1 at the time of diluted epinephrine injection and was unchanged during the entire hydrodissection period in all patients.
The first patients received effect-site concentrations of remifentanil of 4 ng mL -1, respectively. The EC50 of remifentanil for stable hydrodissection was determined by a modification of Dixon's up-and-down method.If the response was "success (SBP during the entire hydrodissection period being ±20% from baseline)," the next target concentration of remifentanil was decreased by a step of 0.5 ng mL -1. If the response was "fail(SBP > ±20% from baseline)," the target concentration was increased by 0.5 ng mL-1.
Saline + PropofolDrug
All procedure would be same in DXM+Propofol group except saline loading rather than DXM loading before induction.
| Study group | Role | What they receive |
|---|---|---|
| DXM + Propofol | Experimental | DXM (1 µg kg -1) was loaded intravenously for 10 min before anaesthesia induction.During DXM loading, the depth of anaesthesia was monitored using a bispectral index (BIS) monitor. Electrocardiogram, heart rate, pulse oximetry, and non-invasive arterial blood pressure were monitored at 2-min intervals.
Anaesthesia was induced with propofol 3.5 μg mL 1 and remifentanil 5 ng mL 1 at an effect site concentration using a target-controlled infusion (TCI) device. Anaesthesia was maintained with propofol and remifentanil continuous infusions.
During surgery except the study period, propofol and remifentanil doses were adjusted to maintain BIS value of 40-60 and systolic blood pressure (SBP) within ±20% from baseline respectively. Receives: Drug: DXM + Propofol |
| Saline + Propofol | Placebo comparator | Saline (1 µg kg -1) was loaded intravenously for 10 min before anaesthesia induction.During saline loading, the depth of anaesthesia was monitored using a bispectral index (BIS) monitor. Electrocardiogram, heart rate, pulse oximetry, and non-invasive arterial blood pressure were monitored at 2-min intervals.
Anaesthesia was induced with propofol 3.5 μg mL 1 and remifentanil 5 ng mL 1 at an effect site concentration using a target-controlled infusion (TCI) device. Anaesthesia was maintained with propofol and remifentanil continuous infusions.
During surgery except the study period, propofol and remifentanil doses were adjusted to maintain BIS value of 40-60 and systolic blood pressure (SBP) within ±20% from baseline respectively. Receives: Drug: Saline + Propofol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Remifentanil EC50 during hydrodissection
Compare remifentanil EC50 for maintaining haemodynamic stability during hydrodissection between 2 groups.
The EC50 of remifentanil for maintaining haemodynamic stability was determined by a modification of Dixon's up-and-down method.If the response was "success (SBP during the entire hydrodissection period being ±20% from baseline)," the next target concentration of remifentanil was decreased by a step of 0.5 ng mL -1. If the response was "fail(SBP > ±20% from baseline)," the target concentration was increased by 0.5 ng mL-1.
Measured: at the time point of hydrodissection intraopeartively
Secondary outcomes (1)
Total doses of remifentanil & propofol administration
Compare total doses of remifentanil and propofol administered intraoperatively between 2 groups.
Measured: Intraoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2014 (estimated)
- Study startMay 2012
- Primary completionSep 2012
- Study completionSep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Robotic ThyroidectomyStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hee-Pyoung Park, Seoul National University Hospital
- Investigators
- Hee Pyung Park, MD PhD, Study director, ProfessorYoung Jin Lim, Md PhD, Principal investigator, Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02102139
- Sponsor's protocol ID
- DXM_Hydrodissection
- Acronym
- DXM_Hydro
- Status last verified
- Mar 2014
- First submitted
- 26 Mar 2014
- Last updated
- 2 Apr 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Preoperative Injection of Dexmedetomidine Attenuates Haemodynamic Responses to Hydrodissection in Patients Undergoing Robotic Thyroidectomy: a Prospective Randomised Double-blinded Study
- ClinicalTrials.gov ID
- NCT02102139
- Acronym / sponsor ID
- DXM_Hydro / DXM_Hydrodissection
- Conditions
- Robotic Thyroidectomy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- May 2012
- Primary completion
- Sep 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 2 Apr 2014 (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.
Percutaneous tunnelling (hydrodissection) in the neck and anterior chest in patients undergoing robotic thyroidectomy leads to significant haemodynamic responses such as increases in blood pressure and heart rate. The investigators evaluated whether a single preoperative dexmedetomidine injection attenuated the haemodynamic responses to hydrodissection by reducing the half-maximal effective concentration (EC50) of remifentanil needed to maintain haemodynamic stability during hydrodissection.
Detailed description
Dexmedetomidine (DXM) is a recently released and approved alpha 2 agonist with a relatively high ratio of α2/α1-activity and an almost fourfold shorter half-life than clonidine.It's sympatholytic, sedative, and analgesic properties makes DXM a useful anaesthetic adjuvant for general anaesthesia. While there are some reports of the beneficial effects of DXM on anaesthetic requirements and haemodynamic responses to endotracheal intubation, the effect of a single preoperative injection of DXM in terms of attenuating haemodymanic responses to surgical stimulation in robot-assisted thyroidectomy is unknown.
When a robotic thyroidectomy using the bilateral axillary breast approach (BABA) technique is performed, subcutaneous tunnelling in the neck and anterior chest, which is defined as hydrodissection, is mandatory. Unfortunately, the procedure leads to significant haemodynamic responses, such as increases in blood pressure and heart rate.
We hypothesised that preoperative DXM administration would attenuate the haemodynamic responses to hydrodissection. This study was designed to evaluate the effects of a single preoperative administration of DXM on haemodynamic responses to hydrodissection in robotic thyroidectomy by comparing the half-maximal effective concentration (EC50) of remifentanil needed to maintain haemodynamic stability during hydrodissection between DXM and control groups. We also investigated the effects of preoperative DXM administration on total doses of remifentanil and propofol administered intraoperatively.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DXM + Propofol | Experimental | Drug: DXM + PropofolDXM (1 µg kg -1) was loaded intravenously for 10 min before anaesthesia induction.During DXM loading, the depth of anaesthesia was monitored using a bispectral index (BIS) monitor. Electrocardiogram, heart rate, pulse oximetry, and non-invasive arterial blood pressure were monitored at 2-min intervals. Anaesthesia was induced with propofol 3.5 μg mL 1 and remifentanil 5 ng mL 1 at an effect site concentration using a target-controlled infusion (TCI) device. Anaesthesia was maintained with propofol and remifentanil continuous infusions. During surgery except the study period, propofol and remifentanil doses were adjusted to maintain BIS value of 40-60 and systolic blood pressure (SBP) within ±20% from baseline respectively. |
| Saline + Propofol | Placebo comparator | Drug: Saline + PropofolSaline (1 µg kg -1) was loaded intravenously for 10 min before anaesthesia induction.During saline loading, the depth of anaesthesia was monitored using a bispectral index (BIS) monitor. Electrocardiogram, heart rate, pulse oximetry, and non-invasive arterial blood pressure were monitored at 2-min intervals. Anaesthesia was induced with propofol 3.5 μg mL 1 and remifentanil 5 ng mL 1 at an effect site concentration using a target-controlled infusion (TCI) device. Anaesthesia was maintained with propofol and remifentanil continuous infusions. During surgery except the study period, propofol and remifentanil doses were adjusted to maintain BIS value of 40-60 and systolic blood pressure (SBP) within ±20% from baseline respectively. |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- ASA physical status I-II patientsscheduled for general anaesthesia for robotic thyroidectomy
Key exclusion criteria (6 listed)
- Patients with an allergy to α2-adrenergic agonists or propofol
- Patients with current antihypertensive medication
- Patients with heart block > 1 degree
- Patients with severe cardiorespiratory dysfunction
- Patients with history of alcohol or drug abuse
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 |
|---|---|---|
| DXM + PropofolAfter induction as mentioned at 'arm description', the effect-site propofol concentration was fixed at 5.0 μg mL-1 at the time of diluted epinephrine injection and was unchanged during the entire hydrodissection period in all patients. The first patients received effect-site concentrations of remifentanil of 4 ng mL -1, respectively. The EC50 of remifentanil for stable hydrodissection was determined by a modification of Dixon's up-and-down method.If the response was "success (SBP during the entire hydrodissection period being ±20% from baseline)," the next target concentration of remifentanil was decreased by a step of 0.5 ng mL -1. If the response was "fail(SBP > ±20% from baseline)," the target concentration was increased by 0.5 ng mL-1. | Drug | DXM + Propofol |
| Saline + PropofolAll procedure would be same in DXM+Propofol group except saline loading rather than DXM loading before induction. | Drug | Saline + Propofol |
Primary outcome
Remifentanil EC50 during hydrodissection
Time frame: at the time point of hydrodissection intraopeartively
Compare remifentanil EC50 for maintaining haemodynamic stability during hydrodissection between 2 groups. The EC50 of remifentanil for maintaining haemodynamic stability was determined by a modification of Dixon's up-and-down method.If the response was "success (SBP during the entire hydrodissection period being ±20% from baseline)," the next target concentration of remifentanil was decreased by a step of 0.5 ng mL -1. If the response was "fail(SBP > ±20% from baseline)," the target concentration was increased by 0.5 ng mL-1.
1 secondary outcome
Total doses of remifentanil & propofol administration
Time frame: Intraoperatively
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 2 Apr 2014.
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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.
Hee Pyung Park, MD PhD study director
Professor
Young Jin Lim, Md PhD principal investigator
Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing DXM + Propofol and Saline + Propofol in people with Robotic Thyroidectomy, run by Seoul National University Hospital at 1 site in South Korea.
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 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: finished, as of the sponsor's last update on 2 Apr 2014. 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 South Korea. 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. Some participants in this study may receive a placebo. 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?
Remifentanil EC50 during hydrodissection (time frame: at the time point of hydrodissection intraopeartively). 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 2 Apr 2014.