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

Not Applicable

Completed

• Conditions: High Altitude; Pregnant
• Interventions: Procedure: cesarian surgery

• Registration Number: NCT05715476
• Lead Sponsor: Giresun University

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.

Study Timeline

• Study First Submitted: 2022-11-28
• Study First Submitted QC: 2023-01-27
• Study Start: 2023-02-01
• Study First Posted: 2023-02-08
• Primary Completion: 2023-03-28
• Study Completion: 2023-04-15
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-07
• Last Update Posted: 2024-05-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 150

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
moderate altitude	cesarian surgery	Pregnant women living in Çorum(moderate altitude),Turkey and undergoing cesarean section under elective conditions.
high altitude	cesarian surgery	Pregnant women living in Van(high altitude),Turkey and undergoing cesarean section under elective conditions.
sea levelaltitude	cesarian surgery	Pregnant women living in Giresun(sea levelaltitude),Turkey and undergoing cesarean section under elective conditions.

Primary Outcome Measures

Name	Time	Method
heart rate	during the surgery	beats/min
American Society of Anesthesiologists (ASA)	preoperative period	ASA I and II
The number and duration of spinal anesthesia applications	during the surgery	second
Body max index	preoperative period	kg/m2
the highest level of sensory block	during the surgery	dermatome level
age	preoperative period	18-40 age frame
mean arterial pressure	during the surgery	mmHg
the duration of sensory block formation in the T6 dermatome	during the surgery	second
the time to reach each score of the MB(Modified bromage scale) scale 1-2-3	during the surgery	second
the duration of the operation (time from the beginning of the surgical incision to the completion of the surgery)	during the surgery	minute

Secondary Outcome Measures

Name	Time	Method
postoperative headache parameter	postoperative first and 7. day	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 nausea and vomiting parameter	postoperative first 24 hour	the degree of postoperative nausea and vomiting will be checked (Verbal Descriptive Scale).
postoperative block parameters	postoperative first 24 hour	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.

Trial Locations

Locations (1)

Gıresun gynecology and children's hospital; 🇹🇷 Giresun, Turkey