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

NCT06268275 | Completed DMC

• 1 other identifier: HE651314
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Hemodynamic Instability

Outcome Measures

Primary Outcomes (4)

• MAP

  Mean arterial pressure

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

• SBP

  Systolic blood pressure

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

• DBP

  Diastolic blood pressure

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

• HR

  Heart rate

  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 (3)

• BIS

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

• Cumulative postoperative opioids consumption

  6 hours and 24 hours postoperatively

• Postoperative adverse events

  Within first 24 hours postoperatively

Study Arms (2)

Group S

EXPERIMENTAL

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.

Procedure: Scalp block

Group E

ACTIVE COMPARATOR

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

Drug: Esmolol

Interventions

Scalp block PROCEDURE

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.

Group S

Esmolol DRUG

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

Group E

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Khon Kaen University: lead

Study Sites (1)

Khon Kaen University

Khon Kaen, Naimuang, Muang, 40002, Thailand

Location

Related Publications (22)

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MeSH Terms

Interventions

esmolol

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Akkhara Olanvoravuth

Model Details: RCT

Study Record Dates

• First Submitted: February 13, 2024
• First Posted: February 20, 2024
• Study Start: September 19, 2022
• Primary Completion: February 1, 2024
• Study Completion: February 13, 2024
• Last Updated: February 20, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: 6 months after publication
• Access Criteria: Researchers who required more information for further study

Locations

TH (1)