Skip to content

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
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05715476
Acronym
altitude
Enrollment
150
Registered
2023-02-08
Start date
2023-02-01
Completion date
2023-04-15
Last updated
2024-05-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

High Altitude, Pregnant

Keywords

high altitude, moderately altitude, cesarian, pregnant

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.

Interventions

PROCEDUREcesarian 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.

Sponsors

Giresun University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
the duration of sensory block formation in the T6 dermatomeduring the surgerysecond
American Society of Anesthesiologists (ASA)preoperative periodASA I and II
mean arterial pressureduring the surgerymmHg
The number and duration of spinal anesthesia applicationsduring the surgerysecond
the duration of the operation (time from the beginning of the surgical incision to the completion of the surgery)during the surgeryminute
the highest level of sensory blockduring the surgerydermatome level
the time to reach each score of the MB(Modified bromage scale) scale 1-2-3during the surgerysecond
agepreoperative period18-40 age frame
Body max indexpreoperative periodkg/m2
heart rateduring the surgerybeats/min

Secondary

MeasureTime frameDescription
postoperative headache parameterpostoperative first and 7. dayOn 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 parameterpostoperative first 24 hourthe degree of postoperative nausea and vomiting will be checked (Verbal Descriptive Scale).
postoperative block parameterspostoperative first 24 hourSensory 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.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026