NCT05005715

Effect of Dexmedetomidine on Quality of Recovery in Non-functioning Pituitary Adenoma Patients Undergoing Endoscopic Transsphenoidal Surgery

Effect of Dexmedetomidine on Intraoperative Neuroendocrine Stress Response and Early Postoperative Quality of Recovery in Non-functioning Pituitary Adenoma Patients Undergoing Endoscopic Transsphenoidal Tumor Surgery

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 64 (estimated)
• Sponsor: Seoul National University Hospital · Academic / Other
• Sex: All
• Age: 20 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

In multiple previous studies that have explored the use of dexmedetomidine in transsphenoidal tumor resection surgery, dexmedetomidine showed many beneficial effects like reducing the requirement of analgesics and anesthetics, improving hemodynamic stability and decreasing the emergence time, extubation time and visual analog scale at emergence. Therefore, the investigators hypothesized that dexmedetomidine would decrease neuroendocrine stress response and improve the quality of postoperative recovery.

Conditions

• Non-functioning Pituitary Adenoma

Interventions

Type	Name	Description
DRUG	Dexmedetomidine	Patients were randomly assigned to the dexmedetomidine or control group. Dexmedetomidine group received intravenous dexmedetomidine and control group received intravenous normal saline during surgery.
DRUG	normal saline	Patients were randomly assigned to the dexmedetomidine or control group. Dexmedetomidine group received intravenous dexmedetomidine and control group received intravenous normal saline during surgery.

Timeline

• Start date: 2021-08-30
• Primary completion: 2022-08-29
• Completion: 2023-08-29
• First posted: 2021-08-13
• Last updated: 2021-08-13

Locations

1 site across 1 country: South Korea

Regulatory

• FDA-regulated drug study