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PregnantaltitudeNCT05715476

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

A study testing cesarian surgery in people with Pregnant and High Altitude, run by Giresun University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 40 years, women onlyHealthy volunteers can take part
Conditions the study is for
Pregnant, High Altitude
What is being tested?
cesarian surgery
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
150 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Feb 2023to 15 Apr 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 40 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 18-40 years old
  • Pregnant women 160-170 centimeters tall
  • Be residing in the place of participation for at least 1 month

Who cannot join

  • >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 locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

  • Gıresun gynecology and children's hospital

    Giresun

Other trials in Turkey (Türkiye)

About this study

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

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.

Read the 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.

Being tested
cesarian surgery
Keywords
high altitude, moderately altitude, cesarian, pregnant
Medical subject headings
Altitude Sickness

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • cesarian surgeryProcedure or surgery

    Also called sea level altitude, moderate altitude, high altitude

    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.

Study groups in NCT05715476
Study groupRoleWhat they receive
sea levelaltitudeActive comparatorPregnant women living in Giresun(sea levelaltitude),Turkey and undergoing cesarean section under elective conditions.
Receives: Procedure: cesarian surgery
moderate altitudeActive comparatorPregnant women living in Çorum(moderate altitude),Turkey and undergoing cesarean section under elective conditions.
Receives: Procedure: cesarian surgery
high altitudeActive comparatorPregnant women living in Van(high altitude),Turkey and undergoing cesarean section under elective conditions.
Receives: Procedure: cesarian surgery

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. age

    18-40 age frame

    Measured: preoperative period

  2. Body max index

    kg/m2

    Measured: preoperative period

  3. heart rate

    beats/min

    Measured: during the surgery

  4. American Society of Anesthesiologists (ASA)

    ASA I and II

    Measured: preoperative period

  5. mean arterial pressure

    mmHg

    Measured: during the surgery

  6. The number and duration of spinal anesthesia applications

    second

    Measured: during the surgery

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

    second

    Measured: during the surgery

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

    second

    Measured: during the surgery

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

    minute

    Measured: during the surgery

  10. the highest level of sensory block

    dermatome level

    Measured: during the surgery

Secondary outcomes (3)

  1. 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.

    Measured: postoperative first 24 hour

  2. 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.

    Measured: postoperative first and 7. day

  3. postoperative nausea and vomiting parameter

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

    Measured: postoperative first 24 hour

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Feb 2023
  2. Study start1 Feb 2023
  3. Primary completion28 Mar 2023
  4. Study completion15 Apr 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
150 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05715476
Sponsor's protocol ID
DYeniay
Acronym
altitude
Status last verified
May 2024
First submitted
28 Nov 2022
Last updated
8 May 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Leissner KB, Mahmood FU. Physiology and pathophysiology at high altitude: considerations for the anesthesiologist. J Anesth. 2009;23(4):543-53. doi: 10.1007/s00540-009-0787-7. Epub 2009 Nov 18.

    PubMed 19921365

  • Penaloza D, Arias-Stella J. The heart and pulmonary circulation at high altitudes: healthy highlanders and chronic mountain sickness. Circulation. 2007 Mar 6;115(9):1132-46. doi: 10.1161/CIRCULATIONAHA.106.624544.

    PubMed 17339571

  • Wilson MH, Edsell ME, Davagnanam I, Hirani SP, Martin DS, Levett DZ, Thornton JS, Golay X, Strycharczuk L, Newman SP, Montgomery HE, Grocott MP, Imray CH; Caudwell Xtreme Everest Research Group. Cerebral artery dilatation maintains cerebral oxygenation at extreme altitude and in acute hypoxia--an ultrasound and MRI study. J Cereb Blood Flow Metab. 2011 Oct;31(10):2019-29. doi: 10.1038/jcbfm.2011.81. Epub 2011 Jun 8.

    PubMed 21654697

  • Blayo MC, Coudert J, Pocidalo JJ. Ccomparison of cisternal and lumbar cerebrospinal fluid pH in high altitude natives. Pflugers Arch. 1975 Apr 29;356(2):159-67. doi: 10.1007/BF00584295.

    PubMed 239384

  • Sorensen SC, Milledge JS. Cerebrospinal fluid acid-base composition at high altitude. J Appl Physiol. 1971 Jul;31(1):28-30. doi: 10.1152/jappl.1971.31.1.28. No abstract available.

    PubMed 5556959

  • Carpenter RL, Hogan QH, Liu SS, Crane B, Moore J. Lumbosacral cerebrospinal fluid volume is the primary determinant of sensory block extent and duration during spinal anesthesia. Anesthesiology. 1998 Jul;89(1):24-9. doi: 10.1097/00000542-199807000-00007.

    PubMed 9667290

  • Hocking G, Wildsmith JA. Intrathecal drug spread. Br J Anaesth. 2004 Oct;93(4):568-78. doi: 10.1093/bja/aeh204. Epub 2004 Jun 25. No abstract available.

    PubMed 15220175

  • Aksoy M, Ince I, Ahiskalioglu A, Karaca O, Bayar F, Erdem AF. Spinal anaesthesia at low and moderately high altitudes: a comparison of anaesthetic parameters and hemodynamic changes. BMC Anesthesiol. 2015 Sep 10;15:123. doi: 10.1186/s12871-015-0104-y.

    PubMed 26357836

Questions about this trial

What is this clinical trial studying?

A study testing cesarian surgery in people with Pregnant and High Altitude, run by Giresun University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 May 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

age (time frame: preoperative period). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05715476, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2024.

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