High Altitude Clinical Trial
— altitudeOfficial title:
The Effect of Different Altitude Levels on Spinal Anesthesia in Cesarean Section Surgery; Comparison of Anesthesia Parameters and Hemodynamic Changes
NCT number | NCT05715476 |
Other study ID # | DYeniay |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | February 1, 2023 |
Est. completion date | April 15, 2023 |
Verified date | May 2024 |
Source | Giresun University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 150 |
Est. completion date | April 15, 2023 |
Est. primary completion date | March 28, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 40 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Turkey | Giresun gynecology and children's hospital | Giresun |
Lead Sponsor | Collaborator |
---|---|
Giresun University |
Turkey,
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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 — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | age | 18-40 age frame | preoperative period | |
Primary | Body max index | kg/m2 | preoperative period | |
Primary | heart rate | beats/min | during the surgery | |
Primary | American Society of Anesthesiologists (ASA) | ASA I and II | preoperative period | |
Primary | mean arterial pressure | mmHg | during the surgery | |
Primary | The number and duration of spinal anesthesia applications | second | during the surgery | |
Primary | the duration of sensory block formation in the T6 dermatome | second | during the surgery | |
Primary | the time to reach each score of the MB(Modified bromage scale) scale 1-2-3 | second | during the surgery | |
Primary | the duration of the operation (time from the beginning of the surgical incision to the completion of the surgery) | minute | during the surgery | |
Primary | the highest level of sensory block | dermatome level | during the surgery | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | postoperative nausea and vomiting parameter | the degree of postoperative nausea and vomiting will be checked (Verbal Descriptive Scale). | postoperative first 24 hour |
Status | Clinical Trial | Phase | |
---|---|---|---|
Enrolling by invitation |
NCT06133530 -
Human Milk Oligosaccharides (HMOs) and Gut Microbiota, Immune System in Antarctica
|
N/A | |
Completed |
NCT02233582 -
Effects of Non-steroidal Anti-inflammatory Drugs (NSAIDS) on Acclimatization to High Altitude
|
Phase 1 | |
Active, not recruiting |
NCT04604249 -
Prevalence of COVID-19 in High Altitude : Insights From the Highest City of the World
|
||
Not yet recruiting |
NCT05063643 -
Cardiotoxicity of Targeted Therapy for HER-2 Positive Breast Cancer Patients at High Altitude
|
||
Recruiting |
NCT05474287 -
SJOV vs. HFNO for Hypoxia During Procedural Sedation at High Altitudes
|
N/A | |
Completed |
NCT06392373 -
High Altitude Muscle Recovery
|
N/A | |
Completed |
NCT03851744 -
High Altitude and Exogenous Carbohydrate Oxidation
|
N/A | |
Completed |
NCT01830530 -
HIGH Altitude CArdiovascular REsearch in the ANDES
|
Phase 4 | |
Completed |
NCT06164665 -
Effects of Pioglitazone on Exogenous Carbohydrate Oxidation During Steady-State Exercise at High Altitude
|
Phase 4 | |
Recruiting |
NCT06393998 -
CO2 Supplement for Treatment of Acute Mountain Sickness
|
N/A | |
Not yet recruiting |
NCT06446427 -
The Effect of Acute High Altitude Exposure on Rescuer Performance and Patient Care
|
N/A | |
Completed |
NCT04915378 -
Hypoxia-altitude Testing to Predict Altitude Related Adverse Health Effects in Chronic Obstructive Pulmonary Disease (COPD) Patients
|
||
Completed |
NCT04290481 -
Oxygen Saturation and Perfusion Index ın Neonates at High Altitude
|
||
Completed |
NCT05798416 -
Effect of Inhalation of Low Dose CO2 on Exercise Performance at High Altitude
|
N/A | |
Recruiting |
NCT05115721 -
Establishing the Reference Interval for Pulse Oxygen Saturation in Neonates at High Altitude
|
||
Recruiting |
NCT06152744 -
Evaluation of Membrane Lung Function in High-altitude Regions
|
||
Recruiting |
NCT05304923 -
Supraglottic Jet Oxygenation and Ventilation for Gastrointestinal Endoscopy at High-altitude
|
N/A | |
Recruiting |
NCT04199650 -
Definition of ARDS in Qinghai Province: Verification of Berlin Definition Plateau Criteria
|