Comparative Low and High Dose of Dexmedethomidine in Pituitary Tumor Removal by Transphenoid Approach
Primary Purpose
Pituitary Tumor
Status
Unknown status
Phase
Phase 4
Locations
Thailand
Study Type
Interventional
Intervention
high dose dexmedethomidine
low dose dexmedethomidine
Sponsored by
About this trial
This is an interventional treatment trial for Pituitary Tumor focused on measuring Dexmedethomidine
Eligibility Criteria
Inclusion Criteria:
- Age18-65
- ASA 1-2
- Elective TNTS resection of Pituitary Tumor
- No narcotic before surgery as premedication
- Able to Extubate
Exclusion Criteria:
- GCS less than 15
- Preoperative Heart Rate less than 50 beat/min
- No Beta-Blockers
- Pregnant patients
- Take any Alpha-Methyldopa, Clonodine, Other Alpha-2 Adrenergic Agonist
- Hemodynamic unstable
- Systolic BP more than 160mmHg
- CAD
- Renal insuffuciency
- Allergy in dexmedethomidine and opioid
- BMI more than 30
- Denied consent
Sites / Locations
- Faculy of Medicine Siriraj hospital Mahidol UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
High dose dexmedethomidine
Low dose dexmedethomidine
Arm Description
High dose is 0.5 microgram/kg/hr
Low dose is 0.2 microgram/kg/hr
Outcomes
Primary Outcome Measures
Comparative Low and High Dose of Dexmedethomidine in Pituitary Tumor Removal by Transphenoid Approach
Low dose is 0.2microgram/kg/hr High dose is 0.5 microgram/kg/hr what is the dose proper and hemodynamic changes. Hemodynamic change means BP is lower than 20% of baseline more than 10minute
Secondary Outcome Measures
Comparative Low and High Dose of Dexmedethomidine in Pituitary Tumor
Low dose is 0.2microgram/kg/hr High dose is 0.5 microgram/kg/hr how much dose blood loss
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03132259
Brief Title
Comparative Low and High Dose of Dexmedethomidine in Pituitary Tumor Removal by Transphenoid Approach
Official Title
Comparative Low and High Dose of Dexmedethomidine Can Stabilize Hemodynamics and Blood Loss in Pituitary Tumor Removal by Transphenoid Approach
Study Type
Interventional
2. Study Status
Record Verification Date
May 2017
Overall Recruitment Status
Unknown status
Study Start Date
May 2016 (undefined)
Primary Completion Date
May 2017 (Anticipated)
Study Completion Date
June 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mahidol University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Transnasal transsphenoidal (TNTS) resection of pituitary tumors involves wide fluctuation in hemodynamic parameter and causes hypertension and tachycardia due to intense noxious stimuli during various stages of surgery. None of routinely used anesthetic agents effectively blunts the undesirable hemodynamic responses, and therefore usually there is a need to use increased doses of anesthetic agents. Dexmedetomidine (DEX) an α-2 adrenergic receptor agonist, because its sympatholytic and antinociceptive properties may ensure optimal intraoperative hemodynamic stability during critical moments of surgical manipulation. In addition, DEX reduced the anesthetic requirement with rapid recovery at the end of surgery. The main aim of the study was to evaluate the effect of DEX on perioperative hemodynamics, anesthetic requirements
Detailed Description
DEX as an anesthetic adjuvant improved hemodynamic stability and decreased anesthetic requirements in patients undergoing TNTS resection of pituitary tumor. In addition, DEX provided better surgical field exposure conditions and early recovery from anesthesia
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pituitary Tumor
Keywords
Dexmedethomidine
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
124 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
High dose dexmedethomidine
Arm Type
Experimental
Arm Description
High dose is 0.5 microgram/kg/hr
Arm Title
Low dose dexmedethomidine
Arm Type
Experimental
Arm Description
Low dose is 0.2 microgram/kg/hr
Intervention Type
Drug
Intervention Name(s)
high dose dexmedethomidine
Other Intervention Name(s)
Precedex
Intervention Description
Dexmedethomidine continuous drip 0.5 mcg/kg/hr a
Intervention Type
Drug
Intervention Name(s)
low dose dexmedethomidine
Intervention Description
Dexmedethomidine continuous drip 0.2 mcg/kg/hr
Primary Outcome Measure Information:
Title
Comparative Low and High Dose of Dexmedethomidine in Pituitary Tumor Removal by Transphenoid Approach
Description
Low dose is 0.2microgram/kg/hr High dose is 0.5 microgram/kg/hr what is the dose proper and hemodynamic changes. Hemodynamic change means BP is lower than 20% of baseline more than 10minute
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
Comparative Low and High Dose of Dexmedethomidine in Pituitary Tumor
Description
Low dose is 0.2microgram/kg/hr High dose is 0.5 microgram/kg/hr how much dose blood loss
Time Frame
24 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Age18-65
ASA 1-2
Elective TNTS resection of Pituitary Tumor
No narcotic before surgery as premedication
Able to Extubate
Exclusion Criteria:
GCS less than 15
Preoperative Heart Rate less than 50 beat/min
No Beta-Blockers
Pregnant patients
Take any Alpha-Methyldopa, Clonodine, Other Alpha-2 Adrenergic Agonist
Hemodynamic unstable
Systolic BP more than 160mmHg
CAD
Renal insuffuciency
Allergy in dexmedethomidine and opioid
BMI more than 30
Denied consent
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Saipin Muangman, physician
Phone
6681 3747786
Email
saipinnoolek@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Sirinuttakul Akkaworakit, physician
Phone
087- 675-8434
Email
gnig.ging@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Saipin Muangman, physician
Organizational Affiliation
Mahidol University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculy of Medicine Siriraj hospital Mahidol University
City
Bangkok
ZIP/Postal Code
10700
Country
Thailand
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Saipin Muangman, physician
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
25493927
Citation
Gopalakrishna KN, Dash PK, Chatterjee N, Easwer HV, Ganesamoorthi A. Dexmedetomidine as an Anesthetic Adjuvant in Patients Undergoing Transsphenoidal Resection of Pituitary Tumor. J Neurosurg Anesthesiol. 2015 Jul;27(3):209-15. doi: 10.1097/ANA.0000000000000144.
Results Reference
result
PubMed Identifier
26229757
Citation
Anjum N, Tabish H, Debdas S, Bani HP, Rajat C, Anjana Basu GD. Effects of dexmedetomidine and clonidine as propofol adjuvants on intra-operative hemodynamics and recovery profiles in patients undergoing laparoscopic cholecystectomy: A prospective randomized comparative study. Avicenna J Med. 2015 Jul-Sep;5(3):67-73. doi: 10.4103/2231-0770.160231.
Results Reference
result
PubMed Identifier
26329913
Citation
Polat R, Peker K, Baran I, Bumin Aydin G, Topcu Guloksuz C, Donmez A. Comparison between dexmedetomidine and remifentanil infusion in emergence agitation during recovery after nasal surgery: A randomized double-blind trial. Anaesthesist. 2015 Oct;64(10):740-6. doi: 10.1007/s00101-015-0077-8. Epub 2015 Sep 2.
Results Reference
result
PubMed Identifier
25293480
Citation
Karwacki Z, Niewiadomski S, Rzaska M, Witkowska M. The effect of bispectral index monitoring on anaesthetic requirements in target-controlled infusion for lumbar microdiscectomy. Anaesthesiol Intensive Ther. 2014 Sep-Oct;46(4):284-8. doi: 10.5603/AIT.2014.0046.
Results Reference
result
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Comparative Low and High Dose of Dexmedethomidine in Pituitary Tumor Removal by Transphenoid Approach
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