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The aim of the researchers in this prospective study is to determine the differences, if any, in terms of anesthetic parameters among pregnant women who live at different altitudes and undergo cesarean section under neuraxial anesthesia under elective conditions and to contribute to the literature.
Increased intra-abdominal pressure during pregnancy increases the pressure in the epidural and spinal space and causes enlargement of the epidural veins. This may lead to easier increases in the anesthetic blockage level. For this reason, it is necessary to use the lowest possible dose of local anesthesia in these individuals compared to normal healthy individuals.
The literature on the effect of altitude difference on central neuraxial block is limited. Based on studies showing changes in CSF volume and content in hypoxic conditions, According to the researchers, with the same amount of local anesthetic, the duration of sensory and motor blockade at sea level is thought to be equal to or longer than in mid-high regions.
This study will be carried out among pregnant women who live in the city center at 3 different altitudes [0-10 m (Giresun), 810 m (Çorum), 1725 m (Van)] and undergo cesarean section under elective conditions. It will be performed in a multicenter, prospective, controlled, randomized manner in order to determine the differences, if any, among these pregnant women in terms of anesthetic parameters.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| sea levelaltitude | Active Comparator | Pregnant women living in Giresun(sea levelaltitude),Turkey and undergoing cesarean section under elective conditions. |
|
| moderate altitude | Active Comparator | Pregnant women living in Çorum(moderate altitude),Turkey and undergoing cesarean section under elective conditions. |
|
| high altitude | Active Comparator | Pregnant women living in Van(high altitude),Turkey and undergoing cesarean section under elective conditions. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cesarian surgery | Procedure | The same anesthesia protocol will be applied to the patient group at each altitude. In the sitting position, the spinal space was entered with a 25 gauge Quincke-tipped needle from the L4-5 space and a drop of CSF will be dripped onto the pH paper. Immediately afterwards, 12 mg of 0.5% hyperbaric bupivacaine will be given. The color formed on the pH paper will be noted. Sensory block level will be tested with pinprick test and motor block level will be evaluated with Modified Bromage scale. The number and duration of spinal anesthesia applications, the time of occurrence of sensory block in the T6 dermatome, the time to reach each score of the MB scale, the duration of the operation, the highest level of sensory block and anesthetic complications will be recorded. Sensory block time and motor block time of the patients followed in the service will be recorded. |
| Measure | Description | Time Frame |
|---|---|---|
| age | 18-40 age frame | preoperative period |
| Body max index | kg/m2 | preoperative period |
| heart rate | beats/min | during the surgery |
| American Society of Anesthesiologists (ASA) | ASA I and II | preoperative period |
| mean arterial pressure | mmHg | during the surgery |
| The number and duration of spinal anesthesia applications | second | during the surgery |
| the duration of sensory block formation in the T6 dermatome | second | during the surgery |
| the time to reach each score of the MB(Modified bromage scale) scale 1-2-3 | second | during the surgery |
| the duration of the operation (time from the beginning of the surgical incision to the completion of the surgery) | minute |
| Measure | Description | Time Frame |
|---|---|---|
| postoperative block parameters | Sensory block time (DBS) (time from local anesthetic injection until S2 dermatome sensation), motor block time (MBS) (time from local anesthetic injection to full motor function recovery) will be evaluated for the patients followed in the service. | postoperative first 24 hour |
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Inclusion Criteria:
Exclusion Criteria:
pregnant woman aged 18-40
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| Name | Affiliation | Role |
|---|---|---|
| Dilek Yeniay | Giresun Universıty TURKEY | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gıresun gynecology and children's hospital | Giresun | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19921365 | Result | Leissner KB, Mahmood FU. Physiology and pathophysiology at high altitude: considerations for the anesthesiologist. J Anesth. 2009;23(4):543-53. doi: 10.1007/s00540-009-0787-7. Epub 2009 Nov 18. | |
| 17339571 | Result | Penaloza D, Arias-Stella J. The heart and pulmonary circulation at high altitudes: healthy highlanders and chronic mountain sickness. Circulation. 2007 Mar 6;115(9):1132-46. doi: 10.1161/CIRCULATIONAHA.106.624544. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 25, 2023 | Jan 26, 2023 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 1, 2023 | Jan 25, 2023 | SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jan 25, 2023 | Jan 26, 2023 | ICF_002.pdf |
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| ID | Term |
|---|---|
| D000532 | Altitude Sickness |
| ID | Term |
|---|---|
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
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| during the surgery |
| the highest level of sensory block | dermatome level | during the surgery |
| postoperative headache parameter |
On the first and seventh days after the operation, the patients will be questioned by the researcher for post-dural puncture headache (PDPH, increased pain intensity when standing up from the supine position) by phone call. |
| postoperative first and 7. day |
| postoperative nausea and vomiting parameter | the degree of postoperative nausea and vomiting will be checked (Verbal Descriptive Scale). | postoperative first 24 hour |
| 21654697 | Result | Wilson MH, Edsell ME, Davagnanam I, Hirani SP, Martin DS, Levett DZ, Thornton JS, Golay X, Strycharczuk L, Newman SP, Montgomery HE, Grocott MP, Imray CH; Caudwell Xtreme Everest Research Group. Cerebral artery dilatation maintains cerebral oxygenation at extreme altitude and in acute hypoxia--an ultrasound and MRI study. J Cereb Blood Flow Metab. 2011 Oct;31(10):2019-29. doi: 10.1038/jcbfm.2011.81. Epub 2011 Jun 8. |
| 239384 | Result | Blayo MC, Coudert J, Pocidalo JJ. Ccomparison of cisternal and lumbar cerebrospinal fluid pH in high altitude natives. Pflugers Arch. 1975 Apr 29;356(2):159-67. doi: 10.1007/BF00584295. |
| 5556959 | Result | Sorensen SC, Milledge JS. Cerebrospinal fluid acid-base composition at high altitude. J Appl Physiol. 1971 Jul;31(1):28-30. doi: 10.1152/jappl.1971.31.1.28. No abstract available. |
| 9667290 | Result | Carpenter RL, Hogan QH, Liu SS, Crane B, Moore J. Lumbosacral cerebrospinal fluid volume is the primary determinant of sensory block extent and duration during spinal anesthesia. Anesthesiology. 1998 Jul;89(1):24-9. doi: 10.1097/00000542-199807000-00007. |
| 15220175 | Result | Hocking G, Wildsmith JA. Intrathecal drug spread. Br J Anaesth. 2004 Oct;93(4):568-78. doi: 10.1093/bja/aeh204. Epub 2004 Jun 25. No abstract available. |
| 26357836 | Result | Aksoy M, Ince I, Ahiskalioglu A, Karaca O, Bayar F, Erdem AF. Spinal anaesthesia at low and moderately high altitudes: a comparison of anaesthetic parameters and hemodynamic changes. BMC Anesthesiol. 2015 Sep 10;15:123. doi: 10.1186/s12871-015-0104-y. |