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Prevention of Post-spinal Anesthesia Hypotension in Caesarean Delivery Using Delayed Supine Positioning

NCT04777123 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 84

Last updated 2021-03-02

No results posted yet for this study

Summary

Maternal hypotension is a common complication after spinal anaesthesia for caesarean delivery. Prophylaxis against post-spinal hypotension (PSH) during caesarean delivery would prevent serious maternal and fetal complications. Various methods had been investigated for prophylaxis against maternal hypotension. The basic components of management of PSH are: 1. Fluid loading. 2. Pharmacological agents. 3. Positioning protocols. Although Fluid loading is superior to non-loading protocols during caesarean delivery, the incidence of Post-spinal hypotension is high with all fluid loading protocols. Thus; the value of fluid loading in caesarean delivery could not be used solely for prevention of PSH. Using vasopressors for prophylaxis against PSH is nearly fundamental during caesarean delivery. However, vasopressors are not devoid of side effects such as reflex bradycardia after phenylephrine and fetal acidosis after ephedrine. Thus, combining vasopressor prophylaxis and non-pharmacological protocols would help to decrease the dose of vasopressors, and consequently decreasing their side effects. Ondansetron had been also reported as a useful prophylactic drug from PSH with minimal side effects. Positioning protocols, such as operating table tilting or flexing, the use of wedges or mechanical displacers, leg wrapping or sequential compression devices, head down and head up positioning aim to reversing aortocaval compression and/or increasing venous return. The sitting position for a short period after spinal block in order to slow the onset of the spinal block. Keeping the patient in the sitting position after spinal block would also prevent extension of local anaesthetic solution to upper thoracic dermatomes which is an important factor in preventing maternal hypotension.

no previous reports had evaluated the impact of sitting position within the context of a multimodal protocol for prophylaxis against maternal hypotension. In this study, we aim to evaluate the impact of 2-minute sitting position after spinal anesthesia on maternal hemodynamics when combined with prophylactic norepinephrine infusion plus preoperative bolus of ondansetron. We aim to reach the best possible maternal hemodynamic profile in addition to maintenance of adequate block level.

Conditions

Interventions

OTHER

sitting position

patients will be left seated for 2 minutes after subarachnoid injection

Sponsors & Collaborators

  • Cairo University

    lead OTHER

Principal Investigators

  • Ahmed Hasanin · Cairo University Kasr Alainy Faculty of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-03-31
Primary Completion
2021-06-30
Completion
2021-06-30

Countries

  • Egypt

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04777123 on ClinicalTrials.gov