Clinical trial NCT06268275: Comparison of Effects of Scalp Block and Intravenous Esmolol on Hemodynamic Response Following the Skull Pins Application for Elective Supratentorial Craniotomy
Official title: Comparison of Effects of Scalp Block and Intravenous Esmolol on Hemodynamic Response Following the Skull Pins Application for Elective Supratentorial Craniotomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hemodynamic Instability
Lead sponsor: Khon Kaen University
Sponsor class: OTHER
First posted: 2024-02-20
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: RCT
Primary purpose: PREVENTION

Brief summary: The goal of this clinical trial is to compare hemodynamic response (MAP, SBP, DBP and HR) between scalp block and intravenous esmolol while skull pins application in patients undergoing elective supratentorial craniotomy under general anesthesia.


Eligibility criteria: Inclusion Criteria:

* Age 18-65 years old
* BMI 18-30 kg/m2
* American Society of Anesthesiologists (ASA) status I-III
* Elective supratentorial craniotomy under general anesthesia
* Required application of skull pins

Exclusion Criteria:

* Poor controlled hypertensive condition (Baseline BP ≥ 160/110 mmHg)
* Thrombocytopenia / Coagulopathy
* Preoperative atrioventricular block (More than 2nd degree AV block)
* Emergency surgery
* Posterior fossa / Intracranial aneurysm surgery
* Pregnancy
* Chronic use of pain control
* Contraindication to beta-blockers
* Allergy to the drugs used in the study

Primary outcomes:
measure: MAP
timeFrame: Baseline, 1 minute before skull pins, then 30 sec, 60 sec, 90 sec, 120 sec, 180 sec and 300 sec after skull pins
measure: SBP
timeFrame: Baseline, 1 minute before skull pins, then 30 sec, 60 sec, 90 sec, 120 sec, 180 sec and 300 sec after skull pins
measure: DBP
timeFrame: Baseline, 1 minute before skull pins, then 30 sec, 60 sec, 90 sec, 120 sec, 180 sec and 300 sec after skull pins
measure: HR
timeFrame: Baseline, 1 minute before skull pins, then 30 sec, 60 sec, 90 sec, 120 sec, 180 sec and 300 sec after skull pins
Secondary outcomes:
measure: BIS
timeFrame: Baseline, 1 minute before skull pins, then 30 sec, 60 sec, 90 sec, 120 sec, 180 sec and 300 sec after skull pins
measure: Cumulative postoperative opioids consumption
timeFrame: 6 hours and 24 hours postoperatively
measure: Postoperative adverse events
timeFrame: Within first 24 hours postoperatively
Other outcomes:
Locations:
city: Khon Kaen
country: Thailand
facility: Khon Kaen University
state: Naimuang, Muang
Study officials:
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