Comparative Low and High Dose of Dexmedethomidine in Pituitary Tumor Removal by Transphenoid Approach

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03132259
• Other study ID #: 116/2559
• Status: Recruiting
• Phase: Phase 4
• First received: July 18, 2016
• Last updated: May 25, 2017
• Start date: May 2016
• Est. completion date: June 2018

Study information

• Verified date: May 2017
• Source: Mahidol University
• Contact: Saipin Muangman, physician
• Phone: 6681 3747786
• Email: saipinnoolek[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Pituitary Diseases
• Pituitary Neoplasms
• Pituitary Tumor

Intervention

Drug:
• high dose dexmedethomidine
Dexmedethomidine continuous drip 0.5 mcg/kg/hr a
• low dose dexmedethomidine
Dexmedethomidine continuous drip 0.2 mcg/kg/hr

Locations

Country	Name	City	State
Thailand	Faculy of Medicine Siriraj hospital Mahidol University	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Mahidol University

Country where clinical trial is conducted

Thailand, 

References & Publications (4)

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

Outcome

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