Comparative Low and High Dose of Dexmedethomidine in Pituitary Tumor Removal by Transphenoid Approach
1 other identifier
interventional
124
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started May 2016
Typical duration for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2016
CompletedFirst Submitted
Initial submission to the registry
July 18, 2016
CompletedFirst Posted
Study publicly available on registry
April 27, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2018
CompletedMay 30, 2017
May 1, 2017
1 year
July 18, 2016
May 25, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
24 hours
Secondary Outcomes (1)
Comparative Low and High Dose of Dexmedethomidine in Pituitary Tumor
24 hours
Study Arms (2)
High dose dexmedethomidine
EXPERIMENTALHigh dose is 0.5 microgram/kg/hr
Low dose dexmedethomidine
EXPERIMENTALLow dose is 0.2 microgram/kg/hr
Interventions
Dexmedethomidine continuous drip 0.5 mcg/kg/hr a
Dexmedethomidine continuous drip 0.2 mcg/kg/hr
Eligibility Criteria
You may qualify if:
- Age18-65
- ASA 1-2
- Elective TNTS resection of Pituitary Tumor
- No narcotic before surgery as premedication
- Able to Extubate
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Faculy of Medicine Siriraj hospital Mahidol University
Bangkok, 10700, Thailand
Related Publications (4)
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.
PMID: 25493927RESULTAnjum 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.
PMID: 26229757RESULTPolat 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.
PMID: 26329913RESULTKarwacki 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.
PMID: 25293480RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Saipin Muangman, physician
Mahidol University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assisted Professor
Study Record Dates
First Submitted
July 18, 2016
First Posted
April 27, 2017
Study Start
May 1, 2016
Primary Completion
May 1, 2017
Study Completion
June 1, 2018
Last Updated
May 30, 2017
Record last verified: 2017-05