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

Giresun University

Status: Completed

Conditions: Pregnant; High Altitude

Treatments: Procedure: cesarian surgery

Study type: Interventional

Funder types: Other

Identifiers

NCT05715476

DYeniay

Details and patient eligibility

About

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.

Full 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.

Enrollment: 150 patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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150 participants in 3 patient groups

sea levelaltitude

Active Comparator group

Description:

Pregnant women living in Giresun(sea levelaltitude),Turkey and undergoing cesarean section under elective conditions.

Treatment:

Procedure: cesarian surgery

moderate altitude

Active Comparator group

Description:

Pregnant women living in Çorum(moderate altitude),Turkey and undergoing cesarean section under elective conditions.

Treatment:

Procedure: cesarian surgery

high altitude

Active Comparator group

Description:

Pregnant women living in Van(high altitude),Turkey and undergoing cesarean section under elective conditions.

Treatment:

Procedure: cesarian surgery