Pituitary Tumor Clinical Trial
Official title:
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
Status | Recruiting |
Enrollment | 124 |
Est. completion date | June 2018 |
Est. primary completion date | May 2017 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility |
Inclusion Criteria: 1. Age18-65 2. ASA 1-2 3. Elective TNTS resection of Pituitary Tumor 4. No narcotic before surgery as premedication 5. Able to Extubate Exclusion Criteria: 1. GCS less than 15 2. Preoperative Heart Rate less than 50 beat/min 3. No Beta-Blockers 4. Pregnant patients 5. Take any Alpha-Methyldopa, Clonodine, Other Alpha-2 Adrenergic Agonist 6. Hemodynamic unstable 7. Systolic BP more than 160mmHg 8. CAD 9. Renal insuffuciency 10. Allergy in dexmedethomidine and opioid 11. BMI more than 30 12. Denied consent |
Country | Name | City | State |
---|---|---|---|
Thailand | Faculy of Medicine Siriraj hospital Mahidol University | Bangkok |
Lead Sponsor | Collaborator |
---|---|
Mahidol University |
Thailand,
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 randomiz — View 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.0000000000 — View 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 — View Citation
Polat R, Peker K, Baran I, Bumin Aydin G, Topçu Gülöksüz Ç, Dönmez 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):7 — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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 | 24 hours |
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