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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05715476
Other study ID # DYeniay
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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