CClinicalTrials.gg
CompletedNCT06037135Updated Oct 6, 2023

Dexmedetomidine Infusion During Laparoscopic Adrenalectomy

An interventional study of dexmedetomidine and 0.9% normal saline in Pheochromocytoma, sponsored by Yonsei University. Completed at 1 site in Korea, Republic of. Open to participants aged 20 Years to 70 Years. Per ClinicalTrials.gov, last updated 2023-10-06.

Sponsored by Yonsei University · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Registered 10 years 8 months after the study started (first participant enrolled Dec 2012, registered Aug 2023).
Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
20 Years to 70 Years
Sex
All
01

Study summary

The investigators planned this study to investigate the effects of dexmedetomidine administration on intraoperative hemodynamic stability in patients with pheochromocytoma.

02

Conditions studied

  • Pheochromocytoma

Browse trials for

03

In context

Pheochromocytoma

149 studies on the registry are indexed under Pheochromocytoma; 56 are open to participants now.

This study's enrollment of 40 is above the median of 33 across 81 interventional studies indexed under Pheochromocytoma.

Browse Pheochromocytoma studies →

Lead sponsor

Yonsei University is the lead sponsor of 1,387 studies on the registry; 232 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. ages of 20 and 70
  2. American Society of Anesthesiologists(ASA) physical status classification I to III,
  3. planned laparoscopic adrenalectomy for pheochromocytoma.

Exclusion criteria

Exclusion Criteria:

  1. emergency operation,
  2. re-operation,
  3. combined surgery with other departments,
  4. body mass index (BMI) >32 kg/m2,
  5. history of arrhythmias (especially AV nodal block) and ventricular conduction abnormalities,
  6. uncontrolled hypertension (diastolic blood pressure >110mmHg)
  7. bradycardia (heart rate \< 40 beats per minute),
  8. history of heart failure, hepatic and/or renal failure,
  9. history of cerebrovascular disease (cerebral hemorrhage, cerebral ischemia),
  10. history of beta-blocker therapy, 10) history of uncontrolled psychiatric disease.
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
40 participants (actual)

Study arms

  • Experimental
    dexmedetomidine group

    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.

    Drug: dexmedetomidine

  • Active comparator
    Control group

    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.

    Drug: 0.9% normal saline

Interventions

  • Drugdexmedetomidine

    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.

  • Drug0.9% normal saline

    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.

06

What researchers measure

Primary outcomes

  1. Intraoperative hemodynamic stability ( maximum blood pressure during surgery (systolic blood pressure (SBP), diastolic blood pressure (DBP), mean blood pressure (MBP))

    Time frame: during operation

  2. Intraoperative hemodynamic stability (duration of SBP increase by 30% or more from baseline (in minutes)

    Time frame: during operation

  3. Intraoperative hemodynamic stability (duration of SBP exceeding 200 mmHg)

    Time frame: during operation

  4. Intraoperative hemodynamic stability (maximum HR during surgery)

    Time frame: during operation

  5. Intraoperative hemodynamic stability (duration of HR exceeding 110 beats per minute during surgery)

    Time frame: during operation

  6. Intraoperative hemodynamic stability (comparison of the quantity of vasoactive drugs (nitroprusside, esmolol, norepinephrine) used during surgery)

    Time frame: during operation

Secondary outcomes

  1. levels of catecholamines

    the actual secretion levels of catecholamines, specifically epinephrine and norepinephrine, were measured at different time points

    Time frame: immediately after anesthesia induction

  2. levels of catecholamines

    the actual secretion levels of catecholamines, specifically epinephrine and norepinephrine, were measured at different time points

    Time frame: immediately after removal of the pheochromocytoma

  3. levels of catecholamines

    the actual secretion levels of catecholamines, specifically epinephrine and norepinephrine, were measured at different time points

    Time frame: immediately after the completion of surgery

07

Study locations

1 site
  • Severance hospital
    Seoul, Korea, Republic of
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 6, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06037135
Lead sponsor
Yonsei University
Responsible party
Sponsor
First posted
Sep 14, 2023
Start date
Dec 3, 2012
Primary completion
Mar 26, 2021
Completion
Mar 26, 2021
Last update
Oct 6, 2023

Study contacts

Young Jun Oh, M.D., Ph.D.
principal investigator · Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2023. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion