The Effect of Different Altitude Levels on Spinal Anesthesia in Cesarean Section Surgery

High Altitude Clinical Trial

— altitude  

Official title:

The Effect of Different Altitude Levels on Spinal Anesthesia in Cesarean Section Surgery; Comparison of Anesthesia Parameters and Hemodynamic Changes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05715476
• Other study ID #: DYeniay
• Status: Completed
• Phase: N/A
• Start date: February 1, 2023
• Est. completion date: April 15, 2023

Study information

• Verified date: May 2024
• Source: Giresun University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: April 15, 2023
• Est. primary completion date: March 28, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• High Altitude
• Pregnant

Intervention

Procedure:
• cesarian surgery
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.

Locations

Country	Name	City	State
Turkey	Giresun gynecology and children's hospital	Giresun

Sponsors (1)

Lead Sponsor	Collaborator
Giresun University

Country where clinical trial is conducted

Turkey, 

References & Publications (8)

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. — View 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. — View 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. — View 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. — View Citation

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. — View 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. — View 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. — View 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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	age	18-40 age frame	preoperative period
Primary	Body max index	kg/m2	preoperative period
Primary	heart rate	beats/min	during the surgery
Primary	American Society of Anesthesiologists (ASA)	ASA I and II	preoperative period
Primary	mean arterial pressure	mmHg	during the surgery
Primary	The number and duration of spinal anesthesia applications	second	during the surgery
Primary	the duration of sensory block formation in the T6 dermatome	second	during the surgery
Primary	the time to reach each score of the MB(Modified bromage scale) scale 1-2-3	second	during the surgery
Primary	the duration of the operation (time from the beginning of the surgical incision to the completion of the surgery)	minute	during the surgery
Primary	the highest level of sensory block	dermatome level	during the surgery
Secondary	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
Secondary	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
Secondary	postoperative nausea and vomiting parameter	the degree of postoperative nausea and vomiting will be checked (Verbal Descriptive Scale).	postoperative first 24 hour