Comparison of Effects of Scalp Block and Intravenous Esmolol on Hemodynamic Response Following the Skull Pins Application for Elective Supratentorial Craniotomy

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06268275

Enrollment

Registered

2024-02-20

Start date

2022-09-19

Completion date

2024-02-13

Last updated

2024-02-20

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

Conditions

Hemodynamic Instability

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.

Interventions

PROCEDUREScalp block

Receive 30 ml of 0.25% bupivacaine with 1% lidocaine (1:1) with adrenaline 1:200,000 infiltration for 10 minutes before skull pins application.

DRUGEsmolol

Receive Intravenous esmolol 1 mg/kg bolus over 1 minute before skull pins application

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

TRIPLE (Subject, Caregiver, Outcomes Assessor)

Intervention model description

RCT

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
DBP	Baseline, 1 minute before skull pins, then 30 sec, 60 sec, 90 sec, 120 sec, 180 sec and 300 sec after skull pins	Diastolic blood pressure
HR	Baseline, 1 minute before skull pins, then 30 sec, 60 sec, 90 sec, 120 sec, 180 sec and 300 sec after skull pins	Heart rate
MAP	Baseline, 1 minute before skull pins, then 30 sec, 60 sec, 90 sec, 120 sec, 180 sec and 300 sec after skull pins	Mean arterial pressure
SBP	Baseline, 1 minute before skull pins, then 30 sec, 60 sec, 90 sec, 120 sec, 180 sec and 300 sec after skull pins	Systolic blood pressure

Secondary

Measure	Time frame	Description
Postoperative adverse events	Within first 24 hours postoperatively	Incidence (%)
BIS	Baseline, 1 minute before skull pins, then 30 sec, 60 sec, 90 sec, 120 sec, 180 sec and 300 sec after skull pins	Bispectral index
Cumulative postoperative opioids consumption	6 hours and 24 hours postoperatively	Opioids consumption

Countries

Thailand

Outcome results

None listed

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