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

Comparative Low and High Dose of Dexmedethomidine Can Stabilize Hemodynamics and Blood Loss in Pituitary Tumor Removal by Transphenoid Approach

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03132259

Enrollment

124

Registered

2017-04-27

Start date

2016-05-31

Completion date

2018-06-30

Last updated

2017-05-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pituitary Tumor

Keywords

Dexmedethomidine

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

Interventions

DRUGhigh dose dexmedethomidine

Dexmedethomidine continuous drip 0.5 mcg/kg/hr a

DRUGlow dose dexmedethomidine

Dexmedethomidine continuous drip 0.2 mcg/kg/hr

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Comparative Low and High Dose of Dexmedethomidine in Pituitary Tumor Removal by Transphenoid Approach	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

Secondary

Measure	Time frame	Description
Comparative Low and High Dose of Dexmedethomidine in Pituitary Tumor	24 hours	Low dose is 0.2microgram/kg/hr High dose is 0.5 microgram/kg/hr how much dose blood loss

Countries

Thailand

Contacts

Primary ContactSaipin Muangman, physician

saipinnoolek@gmail.com6681 3747786

Backup ContactSirinuttakul Akkaworakit, physician

gnig.ging@gmail.com087- 675-8434

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026