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NCT05427968 Clinical Trial

Comparison of Hypotension During Spinal Anaesthesia for C-section

Hypotension Clinical Trial

Official title:
To Tilt or Not to Tilt?: Comparison of Severity of Hypotension Between Supine and Left Tilt Position During Spinal Anesthesia for Elective C-section

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05427968
Other study ID # 2021-4711-17843
Secondary ID
Status Completed
Phase
First received
Last updated
Start date December 1, 2021
Est. completion date February 1, 2022

Study information
Verified date June 2022
Source Rawalpindi Medical College
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Maternal hypotension during C section has been reported due to aortocaval compression (ACC) by full term uterus in supine position. This study aimed at reporting the effect of left tilt on maternal hemodynamics.

Description:

C-section is usually done in either general anesthesia or regional (epidural or spinal) anesthesia. The choice lies with the mother. In spinal anesthesia the anaesthetic agent is injected into the subarachnoid space. Hypotension in supine position that is associated with full term gravid uterus has been explained by compression of inferior venacava (IVF) and aorta. This aortocaval compression (ACC) can also cause hypotension during C- section after spinal block. The aim of our study was to study the effect of left tilt on systolic (SBP) and diastolic blood pressure (DBP), heart rate and the frequency of phenylephrine used to maintain the blood pressure in normal range.

Recruitment information / eligibility
Status Completed
Enrollment 38
Est. completion date February 1, 2022
Est. primary completion date February 1, 2022
Accepts healthy volunteers No
Gender Female
Age group N/A and older
Eligibility Inclusion Criteria: - Participants = 18 years, undergoing Elective Caesarean Section for term singleton pregnancy, ASA I/II, were included after their consent for the participation of the study. Exclusion Criteria: - Participants with co-morbidities (Hypertension, diabetes mellitus, cardiovascular or cerebrovascular disease and a history of coagulation disorders), any contraindication to spinal anesthesia, with multiple pregnancy, pre-eclampsia, obesity (body mass index > 30 kg.m2), intrauterine growth were excluded from the study.

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Pakistan Rawalpindi Medical University Rawalpindi Punjab

Sponsors (1)
Lead Sponsor Collaborator
Rawalpindi Medical College

Country where clinical trial is conducted

Pakistan, 

Outcome
Type Measure Description Time frame Safety issue
Primary Group 1 - Supine Group Systolic blood pressures decreased significantly in the supine group December 2021 to February 2022
Primary Group 2 - Left tilt Group The decrease in the diastolic blood pressure was marginally significant in the left tilt group. December 2021 to February 2022
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