PheochromocytomaNCT06037135
Dexmedetomidine Infusion During Laparoscopic Adrenalectomy
A study testing dexmedetomidine and 0.9% normal saline in people with Pheochromocytoma, run by Yonsei University at 1 site in South Korea.
Trial summary
The investigators planned this study to investigate the effects of dexmedetomidine administration on intraoperative hemodynamic stability in patients with pheochromocytoma. Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Pheochromocytoma
- What is being tested?
- dexmedetomidine and 0.9% normal saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSouth Korea
- Study dates
- 3 Dec 2012to 26 Mar 2021
- 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 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ages of 20 and 70
- American Society of Anesthesiologists(ASA) physical status classification I to III,
- planned laparoscopic adrenalectomy for pheochromocytoma.
Who cannot join
- emergency operation,
- re-operation,
- combined surgery with other departments,
- body mass index (BMI) >32 kg/m2,
- history of arrhythmias (especially AV nodal block) and ventricular conduction abnormalities,
- uncontrolled hypertension (diastolic blood pressure >110mmHg)
Show all 10Show fewer
- bradycardia (heart rate < 40 beats per minute),
- history of heart failure, hepatic and/or renal failure,
- history of cerebrovascular disease (cerebral hemorrhage, cerebral ischemia),
- history of beta-blocker therapy, 10) history of uncontrolled psychiatric disease.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of Perioperative Dexmedetomidine Infusion on Hemodynamic Stability During Laparoscopic Adrenalectomy for Pheochromocytoma: a Randomized Study
The investigators planned this study to investigate the effects of dexmedetomidine administration on intraoperative hemodynamic stability in patients with pheochromocytoma.
- Conditions
- Pheochromocytoma
- Being tested
- dexmedetomidine, 0.9% normal saline
- Medical subject headings
- Pheochromocytoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dexmedetomidineDrug
In the dexmedetomidine group, dexmedetomidine is administered at a rate of 0.5 μg/kg/h immediately after anesthesia induction and continued until the completion of the surgery. The research nurse, who did not participate in the study other than the management and preparation of the study medication, prepared 50mL of 0.9% normal saline for the control group and a mixture of dexmedetomidine 2 mL and 0.9% normal saline 48 mL (at a concentration of 4 μg/mL) for the dexmedetomidine group.
0.9% normal salineDrug
In the control group, a 0.9% normal saline infusion is initiated at the same rate immediately after anesthesia induction and continued until the end of the operation.
| Study group | Role | What they receive |
|---|---|---|
| dexmedetomidine group | Experimental | In the dexmedetomidine group, dexmedetomidine is administered at a rate of 0.5 μg/kg/h immediately after anesthesia induction and continued until the completion of the surgery. Receives: Drug: dexmedetomidine |
| Control group | Active comparator | In the control group, a 0.9% normal saline infusion is initiated at the same rate immediately after anesthesia induction and continued until the end of the operation. Receives: Drug: 0.9% normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraoperative hemodynamic stability ( maximum blood pressure during surgery (systolic blood pressure (SBP), diastolic blood pressure (DBP), mean blood pressure (MBP))
Measured: during operation
Intraoperative hemodynamic stability (duration of SBP increase by 30% or more from baseline (in minutes)
Measured: during operation
Intraoperative hemodynamic stability (duration of SBP exceeding 200 mmHg)
Measured: during operation
Intraoperative hemodynamic stability (maximum HR during surgery)
Measured: during operation
Intraoperative hemodynamic stability (duration of HR exceeding 110 beats per minute during surgery)
Measured: during operation
Intraoperative hemodynamic stability (comparison of the quantity of vasoactive drugs (nitroprusside, esmolol, norepinephrine) used during surgery)
Measured: during operation
Secondary outcomes (3)
levels of catecholamines
the actual secretion levels of catecholamines, specifically epinephrine and norepinephrine, were measured at different time points
Measured: immediately after anesthesia induction
levels of catecholamines
the actual secretion levels of catecholamines, specifically epinephrine and norepinephrine, were measured at different time points
Measured: immediately after removal of the pheochromocytoma
levels of catecholamines
the actual secretion levels of catecholamines, specifically epinephrine and norepinephrine, were measured at different time points
Measured: immediately after the completion of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2023
- Study start3 Dec 2012
- Primary completion26 Mar 2021
- Study completion26 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PheochromocytomaStudies of the same condition, open and under way.
- More trials run by Yonsei 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Young Jun Oh, M.D., Ph.D., Principal investigator, Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06037135
- Sponsor's protocol ID
- 4-2012-0577
- Status last verified
- Oct 2023
- First submitted
- 8 Aug 2023
- Last updated
- 6 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Perioperative Dexmedetomidine Infusion on Hemodynamic Stability During Laparoscopic Adrenalectomy for Pheochromocytoma: a Randomized Study
- ClinicalTrials.gov ID
- NCT06037135
- Acronym / sponsor ID
- 4-2012-0577
- Conditions
- Pheochromocytoma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 3 Dec 2012 (actual)
- Primary completion
- 26 Mar 2021 (actual)
- Study completion
- 26 Mar 2021 (actual)
- First posted
- 14 Sep 2023 (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.
The investigators planned this study to investigate the effects of dexmedetomidine administration on intraoperative hemodynamic stability in patients with pheochromocytoma.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| dexmedetomidine group | Experimental | Drug: dexmedetomidineIn the dexmedetomidine group, dexmedetomidine is administered at a rate of 0.5 μg/kg/h immediately after anesthesia induction and continued until the completion of the surgery. |
| Control group | Active comparator | Drug: 0.9% normal salineIn the control group, a 0.9% normal saline infusion is initiated at the same rate immediately after anesthesia induction and continued until the end of the operation. |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- ages of 20 and 70
- American Society of Anesthesiologists(ASA) physical status classification I to III,
- planned laparoscopic adrenalectomy for pheochromocytoma.
Key exclusion criteria (10 listed)
- emergency operation,
- re-operation,
- combined surgery with other departments,
- body mass index (BMI) >32 kg/m2,
- history of arrhythmias (especially AV nodal block) and ventricular conduction abnormalities,
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 |
|---|---|---|
| dexmedetomidineIn the dexmedetomidine group, dexmedetomidine is administered at a rate of 0.5 μg/kg/h immediately after anesthesia induction and continued until the completion of the surgery. The research nurse, who did not participate in the study other than the management and preparation of the study medication, prepared 50mL of 0.9% normal saline for the control group and a mixture of dexmedetomidine 2 mL and 0.9% normal saline 48 mL (at a concentration of 4 μg/mL) for the dexmedetomidine group. | Drug | dexmedetomidine group |
| 0.9% normal salineIn the control group, a 0.9% normal saline infusion is initiated at the same rate immediately after anesthesia induction and continued until the end of the operation. | Drug | Control group |
Primary outcome
Intraoperative hemodynamic stability ( maximum blood pressure during surgery (systolic blood pressure (SBP), diastolic blood pressure (DBP), mean blood pressure (MBP))
Time frame: during operation
Intraoperative hemodynamic stability (duration of SBP increase by 30% or more from baseline (in minutes)
Time frame: during operation
Intraoperative hemodynamic stability (duration of SBP exceeding 200 mmHg)
Time frame: during operation
Intraoperative hemodynamic stability (maximum HR during surgery)
Time frame: during operation
Intraoperative hemodynamic stability (duration of HR exceeding 110 beats per minute during surgery)
Time frame: during operation
Intraoperative hemodynamic stability (comparison of the quantity of vasoactive drugs (nitroprusside, esmolol, norepinephrine) used during surgery)
Time frame: during operation
3 secondary outcomes
levels of catecholamines
Time frame: immediately after anesthesia induction
levels of catecholamines
Time frame: immediately after removal of the pheochromocytoma
levels of catecholamines
Time frame: immediately after the completion of surgery
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 6 Oct 2023.
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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.
Young Jun Oh, M.D., Ph.D. principal investigator
Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing dexmedetomidine and 0.9% normal saline in people with Pheochromocytoma, run by Yonsei University 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 3 inclusion and 10 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 6 Oct 2023. 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. 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?
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?
Intraoperative hemodynamic stability ( maximum blood pressure during surgery (systolic blood pressure (SBP), diastolic blood pressure (DBP), mean blood pressure (MBP)) (time frame: during operation). The study lists 6 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 6 Oct 2023.