Ephedrine Doses to Prevent Maternal Hypotension After Spinal Anesthesia in Cesarean Section
NCT ID: NCT06668337
Last Updated: 2024-10-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
120 participants
INTERVENTIONAL
2020-08-01
2022-02-15
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Group A who received normal saline immediately after the administration of the
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
Normal Saline (Placebo)
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.
Group B who received ephedrine at a dosage of 1.25 mg/min immediately after the subarachnoid block
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.
Ephedrine
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.
Group C who received ephedrine at a dosage of 1.5 mg/min immediately after the subarachnoid block
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.
Ephedrine
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.
Interventions
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Normal Saline (Placebo)
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.
Ephedrine
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
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.
Eligibility Criteria
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Inclusion Criteria
* Self-identified as female
* American Society of Anesthesiologists (ASA) physical status II
* Aged between 18 to 40 years
* Full-term singleton pregnancies planned for cesarean delivery under spinal anesthesia
Exclusion Criteria
* Height less than 145 cm
* Presence of severe neurological or psychiatric conditions
* History of pre-eclampsia
* Severe renal or metabolic disorders
* Contraindications to spinal anesthesia
* Antenatal evidence of fetal anomalies
* Cases with severely compromised fetuses requiring immediate general anesthesia
* Baseline systolic blood pressure (SBP) less than 90 mm Hg
* Pregnancy-induced hypertension
* Refusal to provide written consent
18 Years
40 Years
FEMALE
Yes
Sponsors
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B.P. Koirala Institute of Health Sciences
OTHER
Responsible Party
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Narottam Jha
Clinical Professor
Locations
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B.P. koirala Institute of Health Sciences
Dharān, , Nepal
Countries
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Other Identifiers
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IRC/1598/019
Identifier Type: -
Identifier Source: org_study_id