Hypotension After Spinal AnesthesiaPhase 4NCT06668337
Ephedrine Doses to Prevent Maternal Hypotension After Spinal Anesthesia in Cesarean Section
A Phase 4 study testing Ephedrine in people with Hypotension After Spinal Anesthesia and Hypotension During Cesarean Delivery, run by B.P. Koirala Institute of Health Sciences at 1 site in Nepal.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Hypotension After Spinal Anesthesia, Hypotension During Cesarean Delivery
- What is being tested?
- Ephedrine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteNepal
- Study dates
- 1 Aug 2020to 15 Feb 2022
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients undergoing cesarean section
- 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
Who cannot join
- Body mass index (BMI) ≥ 40 kg/m²
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Controlled Trial Comparing the Effectiveness of Different Doses of Ephedrine Infusion in Preventing Maternal Hypotension Following Spinal Anesthesia for Caesarean Section
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.
- Being tested
- Normal Saline (Placebo), Ephedrine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
EphedrineDrug
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.
EphedrineDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: Normal Saline (Placebo) |
| 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. Receives: Drug: Ephedrine |
| 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. Receives: Drug: Ephedrine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2024
- Study start1 Aug 2020
- Primary completion1 Aug 2021
- Study completion15 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypotension After Spinal AnesthesiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- B.P. Koirala Institute of Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Narottam Jha, B.P. Koirala Institute of Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06668337
- Sponsor's protocol ID
- IRC/1598/019
- Status last verified
- Oct 2024
- First submitted
- 30 Oct 2024
- Last updated
- 31 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial Comparing the Effectiveness of Different Doses of Ephedrine Infusion in Preventing Maternal Hypotension Following Spinal Anesthesia for Caesarean Section
- ClinicalTrials.gov ID
- NCT06668337
- Acronym / sponsor ID
- IRC/1598/019
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- B.P. Koirala Institute of Health SciencesUniversity, hospital or other
- Study start
- 1 Aug 2020 (actual)
- Primary completion
- 1 Aug 2021 (actual)
- Study completion
- 15 Feb 2022 (actual)
- First posted
- 31 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A who received normal saline immediately after the administration of the | Placebo comparator | Drug: Normal Saline (Placebo)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 | Drug: EphedrineParticipants 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 | Drug: EphedrineParticipants 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. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Patients undergoing cesarean section
- 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
Key exclusion criteria (11 listed)
- Body mass index (BMI) ≥ 40 kg/m²
- Height less than 145 cm
- Presence of severe neurological or psychiatric conditions
- History of pre-eclampsia
- Severe renal or metabolic disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Drug | Group A who received normal saline immediately after the administration of the |
| EphedrineThe 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. | Drug | Group B who received ephedrine at a dosage of 1.25 mg/min immediately after the subarachnoid block |
| EphedrineThe 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. | Drug | Group C who received ephedrine at a dosage of 1.5 mg/min immediately after the subarachnoid block |
Primary outcome
Incidence of Hypotension in Patients Undergoing Cesarean Section Following Spinal Anesthesia.
Time frame: 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
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2024.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ephedrine in people with Hypotension After Spinal Anesthesia and Hypotension During Cesarean Delivery, run by B.P. Koirala Institute of Health Sciences at 1 site in Nepal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Nepal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Hypotension in Patients Undergoing Cesarean Section Following Spinal Anesthesia. (time frame: 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Oct 2024.