Clinical trial NCT05715476: The Effect of Different Altitude Levels on Spinal Anesthesia in Cesarean Section Surgery
Official title: The Effect of Different Altitude Levels on Spinal Anesthesia in Cesarean Section Surgery; Comparison of Anesthesia Parameters and Hemodynamic Changes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pregnant
High Altitude
Keywords: high altitude
moderately altitude
cesarian
pregnant
Lead sponsor: Giresun University
Sponsor class: OTHER
First posted: 2023-02-08
Enrollment: 150
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 18-40 years old
* Pregnant women 160-170 centimeters tall
* Be residing in the place of participation for at least 1 month

Exclusion Criteria:

* \>ASA 2 pregnant women
* Contraindicated for spinal anesthesia, such as infection or coagulation disorder at the needle insertion site
* Pregnant women to be taken under emergency conditions

Primary outcomes:
measure: age
timeFrame: preoperative period
measure: Body max index
timeFrame: preoperative period
measure: heart rate
timeFrame: during the surgery
measure: American Society of Anesthesiologists (ASA)
timeFrame: preoperative period
measure: mean arterial pressure
timeFrame: during the surgery
measure: The number and duration of spinal anesthesia applications
timeFrame: during the surgery
measure: the duration of sensory block formation in the T6 dermatome
timeFrame: during the surgery
measure: the time to reach each score of the MB(Modified bromage scale) scale 1-2-3
timeFrame: during the surgery
measure: the duration of the operation (time from the beginning of the surgical incision to the completion of the surgery)
timeFrame: during the surgery
measure: the highest level of sensory block
timeFrame: during the surgery
Secondary outcomes:
measure: postoperative block parameters
timeFrame: postoperative first 24 hour
measure: postoperative headache parameter
timeFrame: postoperative first and 7. day
measure: postoperative nausea and vomiting parameter
timeFrame: postoperative first 24 hour
Other outcomes:
Locations:
city: Giresun
country: Turkey
facility: Gıresun gynecology and children's hospital
Study officials:
affiliation: Giresun Universıty TURKEY
name: Dilek Yeniay
role: PRINCIPAL_INVESTIGATOR
References:
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citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.