Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Group E | Active Comparator | Receive intravenous esmolol 1 mg/kg bolus over 1 minute before skull pins application. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Cumulative postoperative opioids consumption | Opioids consumption |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Khon Kaen University | Khon Kaen | Naimuang, Muang | 40002 | Thailand |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17573393 | Background | Fukuda S, Warner DS. Cerebral protection. Br J Anaesth. 2007 Jul;99(1):10-7. doi: 10.1093/bja/aem140. | |
| 27121854 | Background | 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. |
Not provided
Not provided
All collected individual participant data (IPD)
6 months after publication
Researchers who required more information for further study
Not provided
Not provided
RCT
Not provided
Not provided
Not provided
| Esmolol | Drug | Receive Intravenous esmolol 1 mg/kg bolus over 1 minute before skull pins application |
|
| 6 hours and 24 hours postoperatively |
| Postoperative adverse events | Incidence (%) | Within first 24 hours postoperatively |
| 9085997 | Background | 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. |
| Background | 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. |
| 26889282 | Background | 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. |
| Background | Yang SH, Liu R. Cerebral Autoregulation. In: Primer on Cerebrovascular Diseases [Internet]. Elsevier; 2017 [cited 2022 Jun 10]. p. 57-60. |
| 17167618 | Background | 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. |
| 20479668 | Background | 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. |
| 32480196 | Background | 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. |
| 8695076 | Background | 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. |
| 11426091 | Background | 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. |
| 19262392 | Background | 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. |
| Background | 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. |
| 31153358 | Background | 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. |
| 26474504 | Background | 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. |
| 28413270 | Background | 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. |
| 29028742 | Background | 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. |
| 32555939 | Background | 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. |
| 33329844 | Background | 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. |
| Background | 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/ |
| 19665383 | Background | 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. |
| 31834247 | Background | 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. |
| ID | Term |
|---|---|
| C036604 | esmolol |
Not provided
Not provided
Not provided