Comparison of Hypotension During Spinal Anaesthesia for C-section

NCT ID: NCT05427968

Last Updated: 2022-06-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

38 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-12-01

Study Completion Date

2022-02-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hypotension Cesarean Section Aortocaval Compression

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Supine group

Spinal anaesthesia was administered in sitting position and then supine position was maintained.

No interventions assigned to this group

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.

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Rawalpindi Medical College

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Rubaid Azhar Dhillon

MBBS

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Rawalpindi Medical University

Rawalpindi, Punjab Province, Pakistan

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Pakistan

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2021-4711-17843

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.