Comparison of Effects of Scalp Block and Intravenous Esmolol on Hemodynamic Response Following the Skull Pins Application for Elective Supratentorial Craniotomy
NCT ID: NCT06268275
Last Updated: 2024-02-20
Study Results
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Basic Information
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COMPLETED
NA
90 participants
INTERVENTIONAL
2022-09-19
2024-02-13
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
TRIPLE
Study Groups
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Group S
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.
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.
Group E
Receive intravenous esmolol 1 mg/kg bolus over 1 minute before skull pins application.
Esmolol
Receive Intravenous esmolol 1 mg/kg bolus over 1 minute before skull pins application
Interventions
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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.
Esmolol
Receive Intravenous esmolol 1 mg/kg bolus over 1 minute before skull pins application
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
65 Years
ALL
Yes
Sponsors
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Khon Kaen University
OTHER
Responsible Party
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Akkhara Olanvoravuth
Akkhara Olanvoravuth
Locations
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Khon Kaen University
Khon Kaen, Naimuang, Muang, Thailand
Countries
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References
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Fukuda S, Warner DS. Cerebral protection. Br J Anaesth. 2007 Jul;99(1):10-7. doi: 10.1093/bja/aem140.
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.
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.
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.
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.
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.
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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.
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.
Watts R, Thiruvenkatarajan V, Calvert M, Newcombe G, van Wijk RM. The effect of perioperative esmolol on early postoperative pain: A systematic review and meta-analysis. J Anaesthesiol Clin Pharmacol. 2017 Jan-Mar;33(1):28-39. doi: 10.4103/0970-9185.202182.
Gelineau AM, King MR, Ladha KS, Burns SM, Houle T, Anderson TA. Intraoperative Esmolol as an Adjunct for Perioperative Opioid and Postoperative Pain Reduction: A Systematic Review, Meta-analysis, and Meta-regression. Anesth Analg. 2018 Mar;126(3):1035-1049. doi: 10.1213/ANE.0000000000002469.
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Kang JK, Yoo SH, Chung JH, Kim NS, Jung HS, Seo YH, Chun HR, Gong HY, Son HD, Kim AJ. Dosing study of esmolol for reducing hemodynamic changes during lightwand intubation. Anesth Pain Med (Seoul). 2020 Oct 30;15(4):417-423. doi: 10.17085/apm.19067.
Sola C, Dadure C, Choquet O, Capdevila X. Nerve Blocks of The Face. NYSORA [Internet]. 2018 Sep 17 [cited 2022 Jun 10]; Available from: https://www.nysora.com/techniques/head-and-neck-blocks/nerve-blocks-face/
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Uribe AA, Stoicea N, Echeverria-Villalobos M, Todeschini AB, Esparza Gutierrez A, Folea AR, Bergese SD. Postoperative Nausea and Vomiting After Craniotomy: An Evidence-based Review of General Considerations, Risk Factors, and Management. J Neurosurg Anesthesiol. 2021 Jul 1;33(3):212-220. doi: 10.1097/ANA.0000000000000667.
Other Identifiers
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HE651314
Identifier Type: -
Identifier Source: org_study_id
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