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Clinical Trials/NCT06037135
NCT06037135
Completed
Not Applicable

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

Yonsei University1 site in 1 country40 target enrollmentDecember 3, 2012

Overview

Phase
Not Applicable
Intervention
dexmedetomidine
Conditions
Pheochromocytoma
Sponsor
Yonsei University
Enrollment
40
Locations
1
Primary Endpoint
Intraoperative hemodynamic stability (duration of SBP exceeding 200 mmHg)
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

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

Registry
clinicaltrials.gov
Start Date
December 3, 2012
End Date
March 26, 2021
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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.

Arms & Interventions

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.

Intervention: dexmedetomidine

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.

Intervention: 0.9% normal saline

Outcomes

Primary Outcomes

Intraoperative hemodynamic stability (duration of SBP exceeding 200 mmHg)

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 ( maximum blood pressure during surgery (systolic blood pressure (SBP), diastolic blood pressure (DBP), mean blood pressure (MBP))

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

Secondary Outcomes

  • levels of catecholamines(immediately after the completion of surgery)

Study Sites (1)

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