- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03132259
Comparative Low and High Dose of Dexmedethomidine in Pituitary Tumor Removal by Transphenoid Approach
May 25, 2017 updated by: SMuangman, Mahidol University
Comparative Low and High Dose of Dexmedethomidine Can Stabilize Hemodynamics and Blood Loss in Pituitary Tumor Removal by Transphenoid Approach
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
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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
Study Type
Interventional
Enrollment (Anticipated)
124
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Saipin Muangman, physician
- Phone Number: 6681 3747786
- Email: saipinnoolek@gmail.com
Study Contact Backup
- Name: Sirinuttakul Akkaworakit, physician
- Phone Number: 087- 675-8434
- Email: gnig.ging@gmail.com
Study Locations
-
-
-
Bangkok, Thailand, 10700
- Recruiting
- Faculy of Medicine Siriraj hospital Mahidol University
-
Contact:
- Saipin Muangman, physician
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: High dose dexmedethomidine
High dose is 0.5 microgram/kg/hr
|
Dexmedethomidine continuous drip 0.5 mcg/kg/hr a
Other Names:
|
Experimental: Low dose dexmedethomidine
Low dose is 0.2 microgram/kg/hr
|
Dexmedethomidine continuous drip 0.2 mcg/kg/hr
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Comparative Low and High Dose of Dexmedethomidine in Pituitary Tumor Removal by Transphenoid Approach
Time Frame: 24 hours
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Comparative Low and High Dose of Dexmedethomidine in Pituitary Tumor
Time Frame: 24 hours
|
Low dose is 0.2microgram/kg/hr High dose is 0.5 microgram/kg/hr how much dose blood loss
|
24 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Saipin Muangman, physician, Mahidol University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2016
Primary Completion (Anticipated)
May 1, 2017
Study Completion (Anticipated)
June 1, 2018
Study Registration Dates
First Submitted
July 18, 2016
First Submitted That Met QC Criteria
April 24, 2017
First Posted (Actual)
April 27, 2017
Study Record Updates
Last Update Posted (Actual)
May 30, 2017
Last Update Submitted That Met QC Criteria
May 25, 2017
Last Verified
May 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Neoplasms
- Neoplasms by Site
- Endocrine System Diseases
- Endocrine Gland Neoplasms
- Hypothalamic Diseases
- Hypothalamic Neoplasms
- Supratentorial Neoplasms
- Brain Neoplasms
- Central Nervous System Neoplasms
- Nervous System Neoplasms
- Pituitary Neoplasms
- Pituitary Diseases
- Physiological Effects of Drugs
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Analgesics, Non-Narcotic
- Adrenergic alpha-2 Receptor Agonists
- Adrenergic alpha-Agonists
- Adrenergic Agonists
- Hypnotics and Sedatives
- Dexmedetomidine
Other Study ID Numbers
- 116/2559
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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