Dexmedetomidine Infusion During Laparoscopic Adrenalectomy

Not Applicable

Completed

• Conditions: Pheochromocytoma
• Interventions: Drug: 0.9% normal saline; Drug: dexmedetomidine

• Registration Number: NCT06037135
• Lead Sponsor: Yonsei University

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2012-12-03
• Primary Completion: 2021-03-26
• Study Completion: 2021-03-26
• Study First Submitted: 2023-08-08
• Study First Submitted QC: 2023-09-12
• Study First Posted: 2023-09-14
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-03
• Last Update Posted: 2023-10-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control 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.
dexmedetomidine group	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.

Primary Outcome Measures

Name	Time	Method
Intraoperative hemodynamic stability (duration of SBP exceeding 200 mmHg)	during operation
Intraoperative hemodynamic stability (duration of SBP increase by 30% or more from baseline (in minutes)	during operation
Intraoperative hemodynamic stability ( maximum blood pressure during surgery (systolic blood pressure (SBP), diastolic blood pressure (DBP), mean blood pressure (MBP))	during operation
Intraoperative hemodynamic stability (maximum HR during surgery)	during operation
Intraoperative hemodynamic stability (duration of HR exceeding 110 beats per minute during surgery)	during operation
Intraoperative hemodynamic stability (comparison of the quantity of vasoactive drugs (nitroprusside, esmolol, norepinephrine) used during surgery)	during operation

Secondary Outcome Measures

Name	Time	Method
levels of catecholamines	immediately after the completion of surgery	the actual secretion levels of catecholamines, specifically epinephrine and norepinephrine, were measured at different time points

Trial Locations

Locations (1)

Severance hospital; 🇰🇷 Seoul, Korea, Republic of