Comparison of intravenous fluid and ephedrine as a prophylaxis in the prevention of spinal anesthesia induced hypotension among delivering mothers.

Comparison of crystalloid preloading versus ephedrine prophylaxis to prevent spinal anesthesia induced hypotension during cesarean delivery: a randomized clinical trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

PACTR

Registry ID

PACTR202302481261045

Enrollment

Registered

2023-02-03

Start date

2021-12-01

Completion date

Unknown

Last updated

2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pregnancy and Childbirth Anaesthesia

Interventions

Ephedrine Group

Preloading Group

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Mothers with physical status of ASA I and II Those with full term of a single pregnancy Mothers with the age range of 18 to 40 years

Exclusion criteria

Exclusion criteria: Mothers who didn’t consent to participate in the study Those who were not fit for spinal anesthesia Those with a history of allergic reactions to local anesthetics Those with preceding or pregnancy-induced hypertension Patients with coagulopathy of any cause Patients with severe cardiac, respiratory, hepatic or renal diseases Preeclamptic and ecpamptic patients Those who developed emergency conditions during the intraoperative period

Design outcomes

Primary

Measure	Time frame
Blood pressure of every patient in both groups was recorded every three minutes and the mean value for every record as well as the overall perioperative mean systolic blood pressure was computed. The baseline systolic blood pressure of the two study groups was comparable with no significant difference at both bivariate and multivariate levels. After the administration of spinal anesthesia, monitoring blood pressure was continued and significant differences were observed in the measures of systolic blood pressure and it was higher in the ephedrine group in the 7th (p0.05) at all times (Table 3).	—

Measure

Time frame

Blood pressure of every patient in both groups was recorded every three minutes and the mean value for every record as well as the overall perioperative mean systolic blood pressure was computed. The baseline systolic blood pressure of the two study groups was comparable with no significant difference at both bivariate and multivariate levels. After the administration of spinal anesthesia, monitoring blood pressure was continued and significant differences were observed in the measures of systolic blood pressure and it was higher in the ephedrine group in the 7th (p0.05) at all times (Table 3).

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Secondary

Measure	Time frame
The secondary outcomes can be explained by the secondary effect of the the provided interventions. Besides the primary outcome, they also have a secondary outcome on the patient conditions such as nausea and vomiting. The incidences of nausea and vomiting were highly significant both clinically and statistically in the preloading group. 3.3% of the patients in the ephedrine group experienced hypotension requiring rescue dose of ephedrine.	—

Measure

Time frame

The secondary outcomes can be explained by the secondary effect of the the provided interventions. Besides the primary outcome, they also have a secondary outcome on the patient conditions such as nausea and vomiting. The incidences of nausea and vomiting were highly significant both clinically and statistically in the preloading group. 3.3% of the patients in the ephedrine group experienced hypotension requiring rescue dose of ephedrine.

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Countries

Eritrea

Contacts

Public ContactMichael Mengistu

College lecturer and research coordinator

Mikoberaki88@gmail.com002917305987

Outcome results

None listed

Source: PACTR (via WHO ICTRP) · Data processed: Aug 9, 2026