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NCT Number: NCT05715476

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

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.

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Key information

Conditions

Pregnant Altitude Sickness High Altitude Respiration Disorders Respiratory Tract Diseases

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Gıresun gynecology and children's hospital

Giresun, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

cesarian surgery

Procedure

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.

Other names: sea level altitude, moderate altitude, high altitude

Primary outcomes

  1. age

    Time frame: preoperative period

    18-40 age frame

  2. Body max index

    Time frame: preoperative period

    kg/m2

  3. heart rate

    Time frame: during the surgery

    beats/min

  4. American Society of Anesthesiologists (ASA)

    Time frame: preoperative period

    ASA I and II

  5. mean arterial pressure

    Time frame: during the surgery

    mmHg

  6. The number and duration of spinal anesthesia applications

    Time frame: during the surgery

    second

  7. the duration of sensory block formation in the T6 dermatome

    Time frame: during the surgery

    second

  8. the time to reach each score of the MB(Modified bromage scale) scale 1-2-3

    Time frame: during the surgery

    second

  9. the duration of the operation (time from the beginning of the surgical incision to the completion of the surgery)

    Time frame: during the surgery

    minute

  10. the highest level of sensory block

    Time frame: during the surgery

    dermatome level

Secondary outcomes

  1. postoperative block parameters

    Time frame: 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.

  2. postoperative headache parameter

    Time frame: 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.

  3. postoperative nausea and vomiting parameter

    Time frame: postoperative first 24 hour

    the degree of postoperative nausea and vomiting will be checked (Verbal Descriptive Scale).

Sponsors and collaborators

Lead sponsor

Giresun University

Other

Registry information

Official study title

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

Acronym: altitude

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Feb 8, 2023
Registry last updated
May 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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