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

Hemodynamic Instability Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06268275
• Other study ID #: HE651314
• Status: Completed
• Phase: N/A
• Start date: September 19, 2022
• Est. completion date: February 13, 2024

Study information

• Verified date: February 2024
• Source: Khon Kaen University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: February 13, 2024
• Est. primary completion date: February 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Hemodynamic Instability

Intervention

Procedure:
• 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.

Drug:
• Esmolol
Receive Intravenous esmolol 1 mg/kg bolus over 1 minute before skull pins application

Locations

Country	Name	City	State
Thailand	Khon Kaen University	Khon Kaen	Naimuang, Muang

Sponsors (1)

Lead Sponsor	Collaborator
Khon Kaen University

Country where clinical trial is conducted

Thailand, 

References & Publications (22)

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. — View Citation

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.

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. — View Citation

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. — View Citation

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. — View Citation

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

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. — View Citation

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. — View Citation

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. — View Citation

Hockey B, Leslie K, Williams D. Dexamethasone for intracranial neurosurgery and anaesthesia. J Clin Neurosci. 2009 Nov;16(11):1389-93. doi: 10.1016/j.jocn.2009.03.007. Epub 2009 Aug 7. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Morais VBD, Sakata RK, Huang APS, Ferraro LHDC. Randomized, double-blind, placebo-controlled study of the analgesic effect of intraoperative esmolol for laparoscopic gastroplasty. Acta Cir Bras. 2020 Jun 5;35(4):e202000408. doi: 10.1590/s0102-865020200040000008. eCollection 2020. — View Citation

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.

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/

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. — View Citation

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. — View Citation

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

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. — View Citation

* Note: There are 22 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	BIS	Bispectral index	Baseline, 1 minute before skull pins, then 30 sec, 60 sec, 90 sec, 120 sec, 180 sec and 300 sec after skull pins
Secondary	Cumulative postoperative opioids consumption	Opioids consumption	6 hours and 24 hours postoperatively
Secondary	Postoperative adverse events	Incidence (%)	Within first 24 hours postoperatively