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Completed

NCT Number: NCT06268275

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

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.

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Key information

Conditions

Hemodynamic Instability

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Khon Kaen University

Khon Kaen, Naimuang, Muang, 40002, Thailand

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

esmolol

Drug

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

Primary outcomes

  1. MAP

    Time frame: 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

  2. SBP

    Time frame: 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

  3. DBP

    Time frame: 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

  4. HR

    Time frame: 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

Secondary outcomes

  1. BIS

    Time frame: 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

  2. Cumulative postoperative opioids consumption

    Time frame: 6 hours and 24 hours postoperatively

    Opioids consumption

  3. Postoperative adverse events

    Time frame: Within first 24 hours postoperatively

    Incidence (%)

Sponsors and collaborators

Lead sponsor

Khon Kaen University

Other

Registry information

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Feb 20, 2024
Registry last updated
Feb 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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