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

NCT05005715 | Unknown Phase 2 FDA Drug

• 1 other identifier: TSA_precedex
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

non-functioning Pituitary Adenoma; endoscopic transsphenoidal tumor surgery; dexmedetomidine; quality of recovery

Outcome Measures

Primary Outcomes (1)

• Quality of recovery-15 (QoR-15) score

  Self-rated questionnaire composed of 15 items (each item: 0-10 points, total: 0-150 points) of five dimensions: physical well-being, physical independence, emotional state, psychological support, and pain. Higher scores indicate better quality of recovery.

  postoperative day 1

Secondary Outcomes (19)

• Serum level of triiodothyronine (T3)

  preoperative (1-2 month before surgery), intraoperative (when surgeon starts tumor resection), immediately postoperative (30 min after the end of surgery)

• Serum level of triiodothyronine (T4)

  preoperative (1-2 month before surgery), intraoperative (when surgeon starts tumor resection), immediately postoperative (30 min after the end of surgery)

• Serum level of thyroid stimulating hormone (TSH)

  preoperative (1-2 month before surgery), intraoperative (when surgeon starts tumor resection), immediately postoperative (30 min after the end of surgery)

• Serum level of luteinizing hormone (LH)

  preoperative (1-2 month before surgery), intraoperative (when surgeon starts tumor resection), immediately postoperative (30 min after the end of surgery)

• Serum level of follicle stimulating hormone (FSH)

  preoperative (1-2 month before surgery), intraoperative (when surgeon starts tumor resection), immediately postoperative (30 min after the end of surgery)

Study Arms (2)

Dexmedetomidine group

ACTIVE COMPARATOR

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.

Drug: Dexmedetomidine

Control group

PLACEBO COMPARATOR

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.

Drug: normal saline

Interventions

Dexmedetomidine 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.

Dexmedetomidine group

normal saline 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

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seoul National University Hospital

Seoul, South Korea

Location

MeSH Terms

Interventions

Dexmedetomidine; Saline Solution

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Central Study Contacts

Hee-pyoung Park, MD, PhD

CONTACT

82-2-2072-2466; hppark@snu.ac.kr

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 26, 2021
• First Posted: August 13, 2021
• Study Start: August 30, 2021
• Primary Completion: August 29, 2022
• Study Completion: August 29, 2023
• Last Updated: August 13, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)