Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This randomized controlled trial aims to compare the effectiveness of different doses of ephedrine infusion in preventing maternal hypotension following spinal anesthesia in parturients undergoing cesarean sections. The study includes 120 participants, aged 18-40 years, with American Society of Anesthesiologists (ASA) physical status II, who are scheduled for elective cesarean delivery. The primary objective is to determine whether low-dose ephedrine infusions at 1.25 mg/min or 1.5 mg/min effectively reduce the incidence of maternal hypotension, with secondary outcomes assessing the need for rescue ephedrine, incidence of side effects (nausea, vomiting, tachycardia), and neonatal Apgar scores. Researchers will compare three groups-saline, 1.25 mg/min ephedrine, and 1.5 mg/min ephedrine-to evaluate their impact on maternal hemodynamic stability.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A who received normal saline immediately after the administration of the | Placebo Comparator | Participants in this group received normal saline immediately after the administration of the subarachnoid block (spinal anesthesia). This group serves as the control group to compare the effectiveness of ephedrine against no pharmacologic intervention |
|
| Group B who received ephedrine at a dosage of 1.25 mg/min immediately after the subarachnoid block | Experimental | Participants in this group received ephedrine at a dosage of 1.25 mg/min immediately after the subarachnoid block. This dose is intended to prevent maternal hypotension by maintaining blood pressure during spinal anesthesia. |
|
| Group C who received ephedrine at a dosage of 1.5 mg/min immediately after the subarachnoid block | Experimental | Participants in this group received ephedrine at a higher dosage of 1.5 mg/min immediately following the subarachnoid block. This intervention tests whether a slightly higher dose of ephedrine provides better prevention of maternal hypotension without increasing side effects. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Normal Saline (Placebo) | Drug | Participants in the control group receive a continuous intravenous infusion of normal saline, which serves as an inert placebo with no pharmacological effect. This intervention mimics the administration of the active treatments, allowing for direct comparison with the ephedrine groups to assess the effectiveness of the drug in preventing maternal hypotension during spinal anesthesia. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Hypotension in Patients Undergoing Cesarean Section Following Spinal Anesthesia. | The primary outcome of the study is the incidence of maternal hypotension, defined as a decrease in systolic blood pressure (SBP) by more than 20% from baseline, in patients who received different doses of ephedrine (1.25 mg/min or 1.5 mg/min) or saline infusion following spinal anesthesia for cesarean section. | Hypotension episodes were monitored and recorded intraoperatively, immediately following the administration of spinal anesthesia until the end of the cesarean section procedure. The time frame for evaluating this outcome was during the surgical procedure |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
This study is open to individuals who self-identify as female. Eligible participants must be of reproductive age and capable of providing informed consent. The focus on females is due to the study's aim to investigate maternal hypotension during spinal anesthesia specifically in the context of cesarean sections.
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| B.P. koirala Institute of Health Sciences | Dharān | Nepal |
Individual participant data will be made available to researchers upon request. The data will be shared in a de-identified format to protect participant confidentiality.
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D000077330 | Saline Solution |
| D004809 | Ephedrine |
| ID | Term |
|---|---|
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Ephedrine | Drug | The interventions in this study include a control group receiving normal saline, which serves as an inert placebo to assess the effectiveness of the active treatments. Participants in Group B receive an ephedrine infusion at 1.25 mg/min, while those in Group C receive a higher dosage of 1.5 mg/min. This design allows for direct comparison of the two dosages of ephedrine against the control, enabling evaluation of their effectiveness in preventing maternal hypotension following spinal anesthesia during cesarean sections. |
|
| Ephedrine | Drug | The interventions in this study include a control group receiving normal saline, which serves as an inert placebo to assess the effectiveness of the active treatments. Participants in Group B receive an ephedrine infusion at 1.25 mg/min, while those in Group C receive a higher dosage of 1.5 mg/min. This design allows for direct comparison of the two dosages of ephedrine against the control, enabling evaluation of their effectiveness in preventing maternal hypotension following spinal anesthesia during cesarean sections. |
|
| D011412 |
| Propanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D020005 | Propanols |
| D000588 | Amines |
| D010627 | Phenethylamines |
| D005021 | Ethylamines |