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

Seoul National University

Status and phase: Unknown; Phase 2

Conditions: Non-functioning Pituitary Adenoma

Treatments: Drug: Dexmedetomidine; Drug: normal saline

Study type: Interventional

Funder types: Other

Identifiers

NCT05005715

TSA_precedex

Details and patient eligibility

About

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.

Enrollment: 64 estimated patients

Sex: All

Ages: 20 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Non-functioning patients undergoing endoscopic transsphenoidal tumor surgery under general anesthesia

Exclusion criteria

• Patients who do not agree to participate in the study
• Patients with contraindication to dexmedetomidine
• Patients with previous history of endoscopic transsphenoidal tumor surgery
• Patients who take anticoagulants or have bleeding disorder
• Patients with conduction block or cardiovascular disease
• Patients with psychiatric disease such as dementia, delirium
• Patients have difficulty filling out the QoR-15 questionnaire
• Pregnant or lactating women
• Patients who have allergies to propofol, remifentanil, fentanyl or rocuronium
• Patients with myasthenia gravis or myasthenic syndrome

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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64 participants in 2 patient groups, including a placebo group

Dexmedetomidine group

Active Comparator group

Description:

After the induction of anesthesia, the dexmedetomidine group received intravenous dexmedetomidine at a loading dose of 1µg/kg for 10 min, followed by a maintenance dose of 0.5µg/kg/h until the end of surgery.

Treatment:

Drug: Dexmedetomidine

Control group

Placebo Comparator group

Description:

After the induction of anesthesia, the control group received intravenous normal saline at the same loading volume for 10 min, followed by the same volume until the end of surgery.

Treatment:

Drug: normal saline