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Hemodynamic InstabilityNCT06268275

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

A study testing Scalp block and Esmolol in people with Hemodynamic Instability, run by Khon Kaen University at 1 site in Thailand.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Hemodynamic Instability
What is being tested?
Scalp block and Esmolol
Could I receive a placebo?
No, everyone receives an active treatment
How many people
90 participants
Where
1 siteThailand
Study dates
19 Sep 2022to 13 Feb 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 9Show fewer
  • Chronic use of pain control
  • Contraindication to beta-blockers
  • Allergy to the drugs used in the study

Trial locations and contacts

1 site in 1 country.

Thailand1 site

  • Khon Kaen University

    Khon Kaen, Naimuang, Muang, 40002

Other trials in Thailand

About this study

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.

Being tested
Scalp block, Esmolol

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Scalp blockProcedure or surgery

    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.

  • EsmololDrug

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

Study groups in NCT06268275
Study groupRoleWhat they receive
Group SExperimentalReceive 30 ml of 0.25% bupivacaine with 1% lidocaine (1:1) with adrenaline 1:200,000 infiltration for 10 minutes before skull pins application.
Receives: Procedure: Scalp block
Group EActive comparatorReceive intravenous esmolol 1 mg/kg bolus over 1 minute before skull pins application.
Receives: Drug: Esmolol

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. MAP

    Mean arterial pressure

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

  2. SBP

    Systolic blood pressure

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

  3. DBP

    Diastolic blood pressure

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

  4. HR

    Heart rate

    Measured: 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)

  1. BIS

    Bispectral index

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

  2. Cumulative postoperative opioids consumption

    Opioids consumption

    Measured: 6 hours and 24 hours postoperatively

  3. Postoperative adverse events

    Incidence (%)

    Measured: Within first 24 hours postoperatively

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Feb 2024
  2. Study start19 Sep 2022
  3. Primary completion1 Feb 2024
  4. Study completion13 Feb 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
RCT
Masking
Triple blind
Who is masked
Participant, Care provider, Outcomes assessor
Enrolment
90 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06268275
Sponsor's protocol ID
HE651314
Status last verified
Feb 2024
First submitted
13 Feb 2024
Last updated
20 Feb 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: All collected individual participant data (IPD)

Publications

  • Fukuda S, Warner DS. Cerebral protection. Br J Anaesth. 2007 Jul;99(1):10-7. doi: 10.1093/bja/aem140.

    PubMed 17573393

  • Li J, Gelb AW, Flexman AM, Ji F, Meng L. Definition, evaluation, and management of brain relaxation during craniotomy. Br J Anaesth. 2016 Jun;116(6):759-69. doi: 10.1093/bja/aew096. Epub 2016 Apr 27.

    PubMed 27121854

  • Colley PS. Blunting the hemodynamic response to skull-pin placement. Anesth Analg. 1997 Apr;84(4):942. doi: 10.1097/00000539-199704000-00056. No abstract available.

    PubMed 9085997

  • Singh G, Arimanikam G, Lionel KR, Smita V, Yadav B, Arulvelan A, et al. Comparison of Dexmedetomidine Infusion versus Scalp Block with 0.5% Ropivacaine to Attenuate Hemodynamic Response to Skull Pin Insertion in Craniotomy: A Prospective, Randomized Controlled Trial. J Neuroanaesth Crit Care. 2021 Sep;08(03):180-6.

  • Bharne S, Bidkar PU, Badhe AS, Parida S, Ramesh AS. Comparison of intravenous labetalol and bupivacaine scalp block on the hemodynamic and entropy changes following skull pin application: A randomized, open label clinical trial. Asian J Neurosurg. 2016 Jan-Mar;11(1):60-5. doi: 10.4103/1793-5482.165801.

    PubMed 26889282

  • Yang SH, Liu R. Cerebral Autoregulation. In: Primer on Cerebrovascular Diseases [Internet]. Elsevier; 2017 [cited 2022 Jun 10]. p. 57-60.

  • Jellish WS, Theard MA, Cheng MA, Leonetti JP, Crowder CM, Tempelhoff R. The effects of clonidine premedication and scalp infiltration of lidocaine on hemodynamic responses to laryngoscopy and skull pin head-holder insertion during skull base procedures. Skull Base. 2001 Aug;11(3):169-76. doi: 10.1055/s-2001-16605.

    PubMed 17167618

  • Misra S, Koshy T, Unnikrishnan KP, Suneel PR, Chatterjee N. Gabapentin premedication decreases the hemodynamic response to skull pin insertion in patients undergoing craniotomy. J Neurosurg Anesthesiol. 2011 Apr;23(2):110-7. doi: 10.1097/ANA.0b013e3181da3c3b.

    PubMed 20479668

  • Koo CH, Jeon S, Kim J, Ryu JH. The effects of intravenous dexmedetomidine on hemodynamic response in patients undergoing skull-pin head-holder application during neurosurgery - A meta-analysis of randomized controlled trials. Clin Neurol Neurosurg. 2020 Aug;195:105939. doi: 10.1016/j.clineuro.2020.105939. Epub 2020 May 20.

    PubMed 32480196

  • Doblar DD, Lim YC, Baykan N, Frenette L. A comparison of alfentanil, esmolol, lidocaine, and thiopental sodium on the hemodynamic response to insertion of headrest skull pins. J Clin Anesth. 1996 Feb;8(1):31-5. doi: 10.1016/0952-8180(95)00169-7.

    PubMed 8695076

  • Agarwal A, Sinha PK, Pandey CM, Gaur A, Pandey CK, Kaushik S. Effect of a subanesthetic dose of intravenous ketamine and/or local anesthetic infiltration on hemodynamic responses to skull-pin placement: a prospective, placebo-controlled, randomized, double-blind study. J Neurosurg Anesthesiol. 2001 Jul;13(3):189-94. doi: 10.1097/00008506-200107000-00002.

    PubMed 11426091

  • Geze S, Yilmaz AA, Tuzuner F. The effect of scalp block and local infiltration on the haemodynamic and stress response to skull-pin placement for craniotomy. Eur J Anaesthesiol. 2009 Apr;26(4):298-303. doi: 10.1097/EJA.0b013e32831aedb2.

    PubMed 19262392

  • Altaf I, Banday J, Naaz S, Ozair E, Punetha P, Challam K. A randomized control trial on comparative effect of scalp nerve block using levobupivacaine versus fentanyl on the attenuation of pain and hemodynamic response to pin fixation. Bali J Anesthesiol. 2021;5(2):66.

  • Yang X, Ma J, Li K, Chen L, Dong R, Lu Y, Zhang Z, Peng M. A comparison of effects of scalp nerve block and local anesthetic infiltration on inflammatory response, hemodynamic response, and postoperative pain in patients undergoing craniotomy for cerebral aneurysms: a randomized controlled trial. BMC Anesthesiol. 2019 Jun 1;19(1):91. doi: 10.1186/s12871-019-0760-4.

    PubMed 31153358

  • Hagan KB, Bhavsar S, Raza SM, Arnold B, Arunkumar R, Dang A, Gottumukkala V, Popat K, Pratt G, Rahlfs T, Cata JP. Enhanced recovery after surgery for oncological craniotomies. J Clin Neurosci. 2016 Feb;24:10-6. doi: 10.1016/j.jocn.2015.08.013. Epub 2015 Oct 21.

    PubMed 26474504

Questions about this trial

What is this clinical trial studying?

A study testing Scalp block and Esmolol in people with Hemodynamic Instability, run by Khon Kaen University at 1 site in Thailand.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06268275, which also lists 22 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2024.

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