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This prospective randomized controlled study will be conducted to compare the effect of fractionated SA using isobaric and hyperbaric bupivacaine with fractionated SA using hyperbaric bupivacaine and the conventional SA on hemodynamic instability in orthogeriatric patients undergoing hip fracture surgeries.
Hip fractures are one of the most common reasons for elderly patients to present to the emergency department and require urgent surgery. Despite the debate regarding the preferred type of anesthesia in the elderly population, spinal anesthesia has shown the advantage of the simplicity of the technique, the better analgesic profile, the lower incidence of thromboembolic events and lower hospital stay. Hemodynamic stability should be considered as a primary intraoperative target. In pursuit of optimizing spinal anesthesia, this study proposed that fractionated SA by sequential administration of low doses of isobaric and hyperbaric bupivacaine can minimize hemodynamic instability while leveraging the advantages of both solutions when compared with fractionated SA using hyperbaric bupivacaine or the conventional SA technique.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fractionated SA with isobaric and hyperbaric bupivacaine | Experimental | patients will receive fractionated SA in two doses first dose of hyperbaric bupivacaine with fentanyl followed after 90 seconds by the second dose of isobaric bupivacaine. |
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| Fractionated SA with hyperbaric bupivacaine group | Active Comparator | patients will receive fractionated SA in two doses of hyperbaric bupivacaine and fentanyl, two thirds of the dose will be given firstly followed by the last third after 90 seconds. |
|
| Conventional SA group | Active Comparator | patients will receive the conventional SA bolus dose of hyperbaric bupivacaine and fentanyl. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fractionated SA with isobaric and hyperbaric bupivacaine | Procedure | patients will receive fractionated SA in two doses first dose of hyperbaric bupivacaine with fentanyl followed after 90 seconds by the second dose of isobaric bupivacaine. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of intraoperative hypotension | Intraoperative hypotension is defined as the drop of systolic blood pressure (SBP) by 25% of the basal reading or the drop of MAP below 65 mmHg. | MAP will be measured intraoperatively before spinal anesthesia (SA), immediately after administering SA and subsequently at regular intervals 5, 10, 20, 30, 60, 75, 90 minutes, and then every 30 minutes till the end of surgery. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of bradycardia. | Bradycardia is defined as sustained HR less than 60 beat/ minute | HR will be measured intraoperatively before spinal anesthesia (SA), immediately after administering SA and subsequently at regular intervals 5, 10, 20, 30, 60, 75, 90 minutes, and then every 30 minutes till the end of surgery. |
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Inclusion Criteria:
Exclusion criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tanta university hospital | Tanta | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31094800 | Result | James LA, Levin MA, Lin HM, Deiner SG. Association of Preoperative Frailty With Intraoperative Hemodynamic Instability and Postoperative Mortality. Anesth Analg. 2019 Jun;128(6):1279-1285. doi: 10.1213/ANE.0000000000004085. | |
| 17462120 | Result | Meyhoff CS, Hesselbjerg L, Koscielniak-Nielsen Z, Rasmussen LS. Biphasic cardiac output changes during onset of spinal anaesthesia in elderly patients. Eur J Anaesthesiol. 2007 Sep;24(9):770-5. doi: 10.1017/S0265021507000427. Epub 2007 Apr 27. |
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The data will be available upon a reasonable request from the corresponding author
The data will be available upon a reasonable request from the corresponding author after the end of the study for 1 year
The data will be available upon a reasonable request from the corresponding author
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|
| Fractionated SA with hyperbaric bupivacaine | Procedure | patients will receive fractionated SA in two doses of hyperbaric bupivacaine and fentanyl, two thirds of the dose will be given firstly followed by the last third after 90 seconds. |
|
|
| Conventional SA group | Procedure | patients will receive the conventional SA bolus dose of hyperbaric bupivacaine and fentanyl. |
|
|
| Vasopressor requirements. |
total dose of vasopressors required intraoperatively |
| intraoperatively after spinal anesthesia till the end of surgical intervention |
| Postoperative pain score | Visual analogue scale (VAS) is typically a 10-cm horizontal line labeled:
A patient marks a point along the line to indicate their level of pain. The score is then measured in centimeters or millimeters to quantify pain intensity. | immediately post operatively then every 30 minutes up to 2 hour |
| Time to first rescue analgesia | time interval from the end of surgery until need of rescue analgesia | post operative .. time interval from the end of surgery until need of rescue analgesia |
| 23635998 | Result | Messina A, Frassanito L, Colombo D, Vergari A, Draisci G, Della Corte F, Antonelli M. Hemodynamic changes associated with spinal and general anesthesia for hip fracture surgery in severe ASA III elderly population: a pilot trial. Minerva Anestesiol. 2013 Sep;79(9):1021-9. Epub 2013 May 2. |
| 35607733 | Result | Alrefaey AK, Bakrey SA. Sequential Intrathecal Injection of Hyperbaric and Isobaric Bupivacaine in Orthogeriatric Lower Limb Surgery, a Prospective Randomized Study. Asian J Anesthesiol. 2022 Jun 1;60(2). doi: 10.6859/aja.202206_60(2).0004. Epub 2022 May 4. |
| 35665737 | Result | Niu Z, Xu X, Chu H, Yin J. Anesthetic management of hip fracture in geriatric patient with respiratory and heart failure using pericapsular nerve group block: A case report. Medicine (Baltimore). 2022 Jun 3;101(22):e29478. doi: 10.1097/MD.0000000000029478. |
| 25232517 | Result | Carpintero P, Caeiro JR, Carpintero R, Morales A, Silva S, Mesa M. Complications of hip fractures: A review. World J Orthop. 2014 Sep 18;5(4):402-11. doi: 10.5312/wjo.v5.i4.402. eCollection 2014 Sep 18. |
| ID | Term |
|---|---|
| C000608097 | DMAC2L protein, human |
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