Dexmedetomidine Infusion During Laparoscopic Adrenalectomy

Pheochromocytoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06037135
• Other study ID #: 4-2012-0577
• Status: Completed
• Phase: N/A
• Start date: December 3, 2012
• Est. completion date: March 26, 2021

Study information

• Verified date: October 2023
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: March 26, 2021
• Est. primary completion date: March 26, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pheochromocytoma

Intervention

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.
• 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.

Locations

Country	Name	City	State
Korea, Republic of	Severance hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intraoperative hemodynamic stability ( maximum blood pressure during surgery (systolic blood pressure (SBP), diastolic blood pressure (DBP), mean blood pressure (MBP))		during operation
Primary	Intraoperative hemodynamic stability (duration of SBP increase by 30% or more from baseline (in minutes)		during operation
Primary	Intraoperative hemodynamic stability (duration of SBP exceeding 200 mmHg)		during operation
Primary	Intraoperative hemodynamic stability (maximum HR during surgery)		during operation
Primary	Intraoperative hemodynamic stability (duration of HR exceeding 110 beats per minute during surgery)		during operation
Primary	Intraoperative hemodynamic stability (comparison of the quantity of vasoactive drugs (nitroprusside, esmolol, norepinephrine) used during surgery)		during operation
Secondary	levels of catecholamines	the actual secretion levels of catecholamines, specifically epinephrine and norepinephrine, were measured at different time points	immediately after anesthesia induction
Secondary	levels of catecholamines	the actual secretion levels of catecholamines, specifically epinephrine and norepinephrine, were measured at different time points	immediately after removal of the pheochromocytoma
Secondary	levels of catecholamines	the actual secretion levels of catecholamines, specifically epinephrine and norepinephrine, were measured at different time points	immediately after the completion of surgery