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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Pregnant, High Altitude

Intervention / Treatment
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* Procedure: cesarian surgery


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: sea levelaltitude<br>Pregnant women living in Giresun(sea levelaltitude),Turkey and undergoing cesarean section under elective conditions. | Procedure: cesarian surgery<br>* 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.<br>* Other names: sea level altitude, moderate altitude, high altitude;|
| Active Comparator: moderate altitude<br>Pregnant women living in Çorum(moderate altitude),Turkey and undergoing cesarean section under elective conditions. | Procedure: cesarian surgery<br>* 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.<br>* Other names: sea level altitude, moderate altitude, high altitude;|
| Active Comparator: high altitude<br>Pregnant women living in Van(high altitude),Turkey and undergoing cesarean section under elective conditions. | Procedure: cesarian surgery<br>* 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.<br>* Other names: sea level altitude, moderate altitude, high altitude;|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| postoperative nausea and vomiting parameter | the degree of postoperative nausea and vomiting will be checked (Verbal Descriptive Scale). | postoperative first 24 hour | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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high altitude, moderately altitude, cesarian, pregnant