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

NCT ID: NCT05005715

Last Updated: 2021-08-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-08-30

Study Completion Date

2023-08-29

Brief Summary

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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.

Detailed Description

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Conditions

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Non-functioning Pituitary Adenoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Participants

Study Groups

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Dexmedetomidine group

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.

Group Type ACTIVE_COMPARATOR

Dexmedetomidine

Intervention Type DRUG

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

Control group

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.

Group Type PLACEBO_COMPARATOR

normal saline

Intervention Type DRUG

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

Interventions

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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.

Intervention Type 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.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Hee-Pyoung Park

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Seoul National University Hospital

Seoul, , South Korea

Site Status

Countries

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South Korea

Central Contacts

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Hee-pyoung Park, MD, PhD

Role: CONTACT

82-2-2072-2466

Other Identifiers

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TSA_precedex

Identifier Type: -

Identifier Source: org_study_id

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