NCT05715476

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 150 (actual)
• Sponsor: Giresun University · Academic / Other
• Sex: Female
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

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.

Conditions

• Pregnant
• High Altitude

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2023-02-01
• Primary completion: 2023-03-28
• Completion: 2023-04-15
• First posted: 2023-02-08
• Last updated: 2024-05-08

Locations

1 site across 1 country: Turkey (Türkiye)