A Superior Anesthetic Technique for the Cesarean Section From a Hemodynamic Perspective.

NCT04989270 | Completed

• 1 other identifier: MREC#2178
• Study Type: observational
• Target: 2,500
• Locations: 1 country
• Sites: 1

Brief Summary

Cesarean section operations are increasing in rates worldwide. A proper anesthetic technique is required to maintain the safety of both the mother and the fetus. This study examines the adverse hemodynamic effects associated with general and regional anesthesia and proposes a superior technique from the hemodynamic perspective. A retrospective cohort study with a five-year study period was conducted on patients who underwent cesarean section with general anesthesia (GA) and regional anesthesia (RA) after obtaining ethical committee approval. Data (hypotension, bradycardia, and blood loss) was collected from hospital information system records of the patients who underwent cesarean section from January 2015 to December 2019. The significance of the variables was determined using the Chi-square test. A total of 2500 patients were studied. 1379 patients underwent cesarean section with RA meanwhile 1121 patients with GA.

Conditions

Obstetric Anaesthesia With Cardiac Complications

Keywords

cesarean section; hemodynamics; general anesthesia; regional anesthesia; intraoperative complications; APGAR Score

Outcome Measures

Primary Outcomes (1)

• Incidence of intraoperative hypotension

  Systolic Blood pressure less than 90 mm hg

  2-3 hours

Secondary Outcomes (2)

• Intraoperative blood loss

  2-3 hours

• Impact on APGAR Score

  2-3 hours

Study Arms (1)

Patients undergoing Cesarean section

Group of patients undergoing Cesarean section between Jan'2015 to Dec'2019

Procedure: General Anesthesia; Procedure: Regional Anesthesia

Interventions

General Anesthesia PROCEDURE

General anesthesia with intubation, ventilation, intravenous and inhalational anesthetics, opioids and muscle paralysis

Patients undergoing Cesarean section

Regional Anesthesia PROCEDURE

Spinal Anesthesia, Epidural Anesthesia

Patients undergoing Cesarean section

Eligibility Criteria

• Age: 17 Years - 48 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

All the patients who underwent Cesarean section under either type of Anesthesia, electively or in an emergency situation, with different indications, were included in the study.

You may qualify if:

• All the patients that underwent CS in SQUH during the study period (Jan'2015 - Dec'2019)

You may not qualify if:

• Patients with missing data

Sponsors & Collaborators

• Sultan Qaboos University: lead

Study Sites (1)

Sultan Qaboos University Hospital

Muscat, 123, Oman

Location

Related Links

• Alnour, T. M., et al (2015) Comparison between the Side Effects of Spinal and General Anesthesia during Caesarean Section in Tripoli-Libya. https://doi.org/10.4172/2155-6148.1000560
• Aregawi, A., et al. (2018) Comparing the Effect of Spinal and General Anaesthesia for Pre-Eclamptic Mothers Who Underwent Caesarean Delivery in A Tertiary, Addis Ababa, Ethiopia, Ethiopian journal of health sciences. NLM
• Chen, Y., et al. (2019) Comparison of effects of general anesthesia and combined spinal/epidural anesthesia for cesarean delivery on umbilical cord blood gas values: A double-blind, randomized, controlled study, Medical Science Mo.
• Kinzhalova, S.; Makarov, R.; Davidova, N. (2013) Comparison of general and spinal anaesthesia on haemodynamic parameters in severe preeclamptic pregnancy undergoing caesarean section, European Journal of Anaesthesiology.
• Ko, S. (2012) Does choice of anesthetics affect intraoperative blood loss?, Korean Journal of Anesthesiology. Korean Society of Anesthesiologists, 295-296.
• tade, A., et al. (2018) Measurements of Inferior Vena Cava Diameter for Prediction of Hypotension and Bradycardia during Spinal Anesthesia in Spontaneously Breathing Patients during Elective Knee Joint Replacement Surgery
• Mavridou, I., Stewart, A. and Fernando, R. (2013) OBSTETRICAL ANESTHESIA (LR LEFFERT, SECTION EDITOR) Maternal Hypotension During Spinal Anesthesia for Cesarean Delivery, Current Anesthesiology Reports 2013 3:4. Springer, 3(4): 282-291.
• Nikooseresht, M., Seif Rabiei, M. A., Hajian, P., Dastaran, R. and Alipour, N. (2016) Comparing the hemodynamic effects of spinal anesthesia in preeclamptic and healthy parturients during cesarean section, Anesthesiology and Pain Medicine.
• Ram, M., et al. (2017) Cardiac hemodynamics before, during and after elective cesarean section under spinal anesthesia in low-risk women, Journal of Perinatology.
• Saha, L. and Chowdhury, S. B. (2011) Study on primary cesarean section., Mymensingh medical journal : MMJ. Bangladesh, 20(2): 292-297.
• Šklebar, I., Bujas, T. and Habek, D. (2019) Spinal anaesthesia-induced hypotension in obstetrics: Prevention and therapy, Acta Clinica Croatica. Klinicka Bolnica Sestre Milosrdnice, 58(Suppl 1): 90-95.
• Stark, A. R., Adamkin, D. H., Batton, D. G., Bell, E. F., Bhutani, V. K., Denson, S. E., … Hawks, D. (2006) The Apgar score, Pediatrics. American Academy of Pediatrics, 1444-1447.

MeSH Terms

Conditions

Intraoperative Complications

Interventions

Anesthesia, General; Anesthesia, Conduction

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anesthesia; Anesthesia and Analgesia

Study Officials

• Jyoti Burad, MD, EDIC

  Sultan Qaboos University Hospital

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 5, 2021
• First Posted: August 4, 2021
• Study Start: July 7, 2020
• Primary Completion: March 31, 2021
• Study Completion: May 15, 2021
• Last Updated: August 4, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: when summary data are published
• Access Criteria: Data might be accessible for any meta-analysis related to the study subject.

Locations

OM (1)