Comparison of Hypotension During Spinal Anaesthesia for C-section

June 16, 2022 updated by: Rubaid Azhar Dhillon, Rawalpindi Medical College

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

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.

Study Overview

Status

Completed

Conditions

Detailed 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.

Study Type

Observational

Enrollment (Actual)

38

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Punjab
      • Rawalpindi, Punjab, Pakistan, 46000
        • Rawalpindi Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Participants after fulfilling the inclusion exclusion criteria were randomized by lottery method into two groups; supine group (Group 1) and left tilt group. (Group 2).

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Supine group
Spinal anaesthesia was administered in sitting position and then supine position was maintained.
Left tilt group
Spinal anesthesia was administered in sitting position was then maintained on supine position until full anesthetic effect (motor and sensory loss) and then table was tilted 15 degrees to the left.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rawalpindi Medical College

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2021

Primary Completion (Actual)

February 1, 2022

Study Completion (Actual)

February 1, 2022

Study Registration Dates

First Submitted

June 16, 2022

First Submitted That Met QC Criteria

June 16, 2022

First Posted (Actual)

June 22, 2022

Study Record Updates

Last Update Posted (Actual)

June 22, 2022

Last Update Submitted That Met QC Criteria

June 16, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021-4711-17843

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Hypotension

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Germany

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe