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Dexmedetomidine Infusion During Laparoscopic Adrenalectomy

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ClinicalTrials.gov Identifier: NCT06037135
Recruitment Status : Completed
First Posted : September 14, 2023
Last Update Posted : October 6, 2023
Sponsor:
Information provided by (Responsible Party):
Yonsei University

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

Condition or disease Intervention/treatment Phase
Pheochromocytoma Drug: dexmedetomidine Drug: 0.9% normal saline Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: The Effects of Perioperative Dexmedetomidine Infusion on Hemodynamic Stability During Laparoscopic Adrenalectomy for Pheochromocytoma: a Randomized Study
Actual Study Start Date : December 3, 2012
Actual Primary Completion Date : March 26, 2021
Actual Study Completion Date : March 26, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pheochromocytoma

Arms and Interventions
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Arm Intervention/treatment
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
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.
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
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.


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  1. levels of catecholamines [ Time Frame: immediately after anesthesia induction ]
    the actual secretion levels of catecholamines, specifically epinephrine and norepinephrine, were measured at different time points

  2. levels of catecholamines [ Time Frame: immediately after removal of the pheochromocytoma ]
    the actual secretion levels of catecholamines, specifically epinephrine and norepinephrine, were measured at different time points

  3. levels of catecholamines [ Time Frame: immediately after the completion of surgery ]
    the actual secretion levels of catecholamines, specifically epinephrine and norepinephrine, were measured at different time points


Eligibility Criteria
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Ages Eligible for Study:   20 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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:

  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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06037135


Locations
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Korea, Republic of
Severance hospital
Seoul, Korea, Republic of
Sponsors and Collaborators
Yonsei University
Investigators
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Principal Investigator: Young Jun Oh, M.D., Ph.D. Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine
More Information
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Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT06037135    
Other Study ID Numbers: 4-2012-0577
First Posted: September 14, 2023    Key Record Dates
Last Update Posted: October 6, 2023
Last Verified: October 2023

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pheochromocytoma
Paraganglioma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Dexmedetomidine
Hypnotics and Sedatives
Central Nervous System Depressants
 Physiological Effects of Drugs
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action