NCT05715476

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 28, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

February 1, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 8, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 28, 2023

Completed
18 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 15, 2023

Completed
Last Updated

May 8, 2024

Status Verified

May 1, 2024

Enrollment Period

2 months

First QC Date

November 28, 2022

Last Update Submit

May 7, 2024

Conditions

PregnantHigh Altitude

Keywords

high altitudemoderately altitudecesarianpregnant

Outcome Measures

Primary Outcomes (10)

  • 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 Outcomes (3)

  • postoperative block parameters

    postoperative first 24 hour

  • postoperative headache parameter

    postoperative first and 7. day

  • postoperative nausea and vomiting parameter

    postoperative first 24 hour

Study Arms (3)

sea levelaltitude

ACTIVE COMPARATOR

Pregnant women living in Giresun(sea levelaltitude),Turkey and undergoing cesarean section under elective conditions.

Procedure: cesarian surgery

moderate altitude

ACTIVE COMPARATOR

Pregnant women living in Çorum(moderate altitude),Turkey and undergoing cesarean section under elective conditions.

Procedure: cesarian surgery

high altitude

ACTIVE COMPARATOR

Pregnant women living in Van(high altitude),Turkey and undergoing cesarean section under elective conditions.

Procedure: cesarian surgery

Interventions

cesarian surgeryPROCEDURE

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.

Also known as: sea level altitude, moderate altitude, high altitude
high altitudemoderate altitudesea levelaltitude

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailspregnant woman aged 18-40
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • \>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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gıresun gynecology and children's hospital

Giresun, Turkey (Türkiye)

Location

Related Publications (8)

  • 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.

    PMID: 19921365RESULT

  • 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.

    PMID: 17339571RESULT

  • 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.

    PMID: 21654697RESULT

  • 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.

    PMID: 239384RESULT

  • 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.

    PMID: 5556959RESULT

  • 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.

    PMID: 9667290RESULT

  • 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.

    PMID: 15220175RESULT

  • 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.

    PMID: 26357836RESULT

MeSH Terms

Conditions

Altitude Sickness

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract Diseases

Study Officials

  • Dilek Yeniay

    Giresun Universıty TURKEY

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Anesthesiology and Reanimation physician

Study Record Dates

First Submitted

November 28, 2022

First Posted

February 8, 2023

Study Start

February 1, 2023

Primary Completion

March 28, 2023

Study Completion

April 15, 2023

Last Updated

May 8, 2024

Record last verified: 2024-05

Locations

TU(1)