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Completed

NCT Number: NCT06037135

Dexmedetomidine Infusion During Laparoscopic Adrenalectomy

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

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Key information

Conditions

Pheochromocytoma Neoplasms Neoplasms by Histologic Type Neoplasms, Germ Cell and Embryonal Neoplasms, Nerve Tissue Neuroectodermal Tumors Neuroendocrine Tumors Paraganglioma

Age range

20 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Severance hospital

Seoul, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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)
  • 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.

Treatment and study plan

Dexmedetomidine

Drug

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 saline

Drug

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.

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

    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

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Registry information

Official study title

The Effects of Perioperative Dexmedetomidine Infusion on Hemodynamic Stability During Laparoscopic Adrenalectomy for Pheochromocytoma: a Randomized Study

Important dates

Study start
2012
Primary completion
2021
Study completion
2021
First posted
Sep 14, 2023
Registry last updated
Oct 6, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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