Clinical trial

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

Name

HE651314

Description

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.

Trial arms

Trial start

2022-09-19

Estimated PCD

2024-02-01

Trial end

2024-02-13

Status

Completed

Treatment

Scalp 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.

Arms:

Group S

Esmolol

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

Arms:

Group E

Size

Primary endpoint

MAP

Baseline, 1 minute before skull pins, then 30 sec, 60 sec, 90 sec, 120 sec, 180 sec and 300 sec after skull pins

SBP

Baseline, 1 minute before skull pins, then 30 sec, 60 sec, 90 sec, 120 sec, 180 sec and 300 sec after skull pins

DBP

Baseline, 1 minute before skull pins, then 30 sec, 60 sec, 90 sec, 120 sec, 180 sec and 300 sec after skull pins

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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'RCT', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 90, 'type': 'ACTUAL'}}

Updated at

2024-02-20

1 organization

1 product

1 indication

Organization

Khon Kaen University

Product

Esmolol

Indication

Hemodynamic Instability