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

Primary Purpose

Non-functioning Pituitary Adenoma

Status
Unknown status
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Dexmedetomidine
normal saline
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Non-functioning Pituitary Adenoma focused on measuring non-functioning Pituitary Adenoma, endoscopic transsphenoidal tumor surgery, dexmedetomidine, quality of recovery

Eligibility Criteria

20 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Seoul National University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Dexmedetomidine group

Control group

Arm 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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Serum level of triiodothyronine (T3)
ng/dL
Serum level of triiodothyronine (T4)
ng/dL
Serum level of thyroid stimulating hormone (TSH)
uIU/mL
Serum level of luteinizing hormone (LH)
mIU/mL
Serum level of follicle stimulating hormone (FSH)
mIU/mL
Serum level of adredocorticotrophic hormone (ACTH)
pg/mL
Serum level of growth hormone (GH)
ng/mL
Serum level of insulin-like growth factor-1 (IGF-1)
ng/mL
Serum level of prolactin
ng/mL
Serum level of antidiuretic hormone (ADH)
pg/ml
Serum level of cortisol
ug/dL
Pain score (visual analogue scale, VAS)
Self-reported measures of symptoms that are recorded with a single handwritten mark placed at one point along the length of a 10-cm line that represents a continuum between the two ends of the scale-"no pain" on the left end (0 cm) of the scale and the "worst pain" on the right end of the scale (10 cm).
Time to the first administration of rescue analgesics after the end of surgery
Total amounts of rescue analgesics
Total amounts of propofol and remifentanil administered during surgery
Time to emergence after the end of surgery
Time to extubation after the end of surgery
Incidence and severity of postoperative complications
nausea, vomiting, etc.
Hospital length of stay

Full Information

First Posted
July 26, 2021
Last Updated
August 11, 2021
Sponsor
Seoul National University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05005715
Brief Title
Effect of Dexmedetomidine on Quality of Recovery in Non-functioning Pituitary Adenoma Patients Undergoing Endoscopic Transsphenoidal Surgery
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Unknown status
Study Start Date
August 30, 2021 (Anticipated)
Primary Completion Date
August 29, 2022 (Anticipated)
Study Completion Date
August 29, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-functioning Pituitary Adenoma
Keywords
non-functioning Pituitary Adenoma, endoscopic transsphenoidal tumor surgery, dexmedetomidine, quality of recovery

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
64 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Dexmedetomidine group
Arm Type
Active Comparator
Arm 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.
Arm Title
Control group
Arm Type
Placebo Comparator
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Dexmedetomidine
Intervention Description
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
Intervention Name(s)
normal saline
Intervention Description
Patients were randomly assigned to the dexmedetomidine or control group. Dexmedetomidine group received intravenous dexmedetomidine and control group received intravenous normal saline during surgery.
Primary Outcome Measure Information:
Title
Quality of recovery-15 (QoR-15) score
Description
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.
Time Frame
postoperative day 1
Secondary Outcome Measure Information:
Title
Serum level of triiodothyronine (T3)
Description
ng/dL
Time Frame
preoperative (1-2 month before surgery), intraoperative (when surgeon starts tumor resection), immediately postoperative (30 min after the end of surgery)
Title
Serum level of triiodothyronine (T4)
Description
ng/dL
Time Frame
preoperative (1-2 month before surgery), intraoperative (when surgeon starts tumor resection), immediately postoperative (30 min after the end of surgery)
Title
Serum level of thyroid stimulating hormone (TSH)
Description
uIU/mL
Time Frame
preoperative (1-2 month before surgery), intraoperative (when surgeon starts tumor resection), immediately postoperative (30 min after the end of surgery)
Title
Serum level of luteinizing hormone (LH)
Description
mIU/mL
Time Frame
preoperative (1-2 month before surgery), intraoperative (when surgeon starts tumor resection), immediately postoperative (30 min after the end of surgery)
Title
Serum level of follicle stimulating hormone (FSH)
Description
mIU/mL
Time Frame
preoperative (1-2 month before surgery), intraoperative (when surgeon starts tumor resection), immediately postoperative (30 min after the end of surgery)
Title
Serum level of adredocorticotrophic hormone (ACTH)
Description
pg/mL
Time Frame
preoperative (1-2 month before surgery), intraoperative (when surgeon starts tumor resection), immediately postoperative (30 min after the end of surgery)
Title
Serum level of growth hormone (GH)
Description
ng/mL
Time Frame
preoperative (1-2 month before surgery), intraoperative (when surgeon starts tumor resection), immediately postoperative (30 min after the end of surgery)
Title
Serum level of insulin-like growth factor-1 (IGF-1)
Description
ng/mL
Time Frame
preoperative (1-2 month before surgery), intraoperative (when surgeon starts tumor resection), immediately postoperative (30 min after the end of surgery)
Title
Serum level of prolactin
Description
ng/mL
Time Frame
preoperative (1-2 month before surgery), intraoperative (when surgeon starts tumor resection), immediately postoperative (30 min after the end of surgery)
Title
Serum level of antidiuretic hormone (ADH)
Description
pg/ml
Time Frame
preoperative (1-2 month before surgery), intraoperative (when surgeon starts tumor resection), immediately postoperative (30 min after the end of surgery)
Title
Serum level of cortisol
Description
ug/dL
Time Frame
preoperative (1-2 month before surgery), intraoperative (when surgeon starts tumor resection), immediately postoperative (30 min after the end of surgery)
Title
Pain score (visual analogue scale, VAS)
Description
Self-reported measures of symptoms that are recorded with a single handwritten mark placed at one point along the length of a 10-cm line that represents a continuum between the two ends of the scale-"no pain" on the left end (0 cm) of the scale and the "worst pain" on the right end of the scale (10 cm).
Time Frame
postoperative 4 hour, 1 day, 2 day
Title
Time to the first administration of rescue analgesics after the end of surgery
Time Frame
postoperative (up to 2 weeks after surgery)
Title
Total amounts of rescue analgesics
Time Frame
postoperative (up to 2 weeks after surgery)
Title
Total amounts of propofol and remifentanil administered during surgery
Time Frame
intraoperative (from induction of anesthesia until end of anesthesia)
Title
Time to emergence after the end of surgery
Time Frame
postoperative (up to 1 day after surgery)
Title
Time to extubation after the end of surgery
Time Frame
postoperative (up to 1 day after surgery)
Title
Incidence and severity of postoperative complications
Description
nausea, vomiting, etc.
Time Frame
postoperative (up to 2 weeks after surgery)
Title
Hospital length of stay
Time Frame
postoperative (up to 2 weeks after surgery)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hee-pyoung Park, MD, PhD
Phone
82-2-2072-2466
Email
hppark@snu.ac.kr
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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