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| Name | Class |
|---|---|
| New York Presbyterian Hospital | OTHER |
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The purpose of this research study is to investigate if the incidence of nausea and vomiting that subjects experience during and after a Cesarean section can be reduced by giving a shot of the drug ephedrine into the thigh muscle at the time of spinal anesthesia administration.
This research project is designed to study the medication ephedrine, when it is given as a routine part of the anesthesia for elective Cesarean section. Ephedrine is a medication that is widely used in labor and in vaginal and operative (Cesarean section) deliveries to help maintain a woman's blood pressure within its normal range, especially after spinal and epidural anesthesia has been administered. The purpose of this study is to determine if ephedrine, when given intramuscularly (<IM> as a shot in the muscle), at the time of spinal anesthesia administration, can help to decrease the incidence of nausea and vomiting subjects experience during and after a Cesarean section. This study will compare women who receive ephedrine to a similar group of women who receive a normal saline placebo. In addition to looking at the difference in the incidence of nausea and vomiting perioperatively, this study will also evaluate if the administration of IM ephedrine helps the baby to receive more blood from the placenta after anesthesia has been administered to the mother. This will be evaluated by performing a simple blood test, drawn from the umbilical cord, after the baby is born.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Saline Placebo | Placebo Comparator | Drug: Saline Placebo 0.5 mL, IM (in the muscle), one time |
|
| IM Ephedrine | Experimental | Drug: Ephedrine [Synonyms: Ephedra, Ephedrinum] 25 mg, IM (in the muscle), one time |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ephedrine [Synonyms: Ephedra, Ephedrinum] | Drug | 25 mg, IM (in the muscle), one time |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Pre-Induction Nausea Score | Subject's self-rated nausea level on a scale of 0-3 immediately prior to induction of spinal anesthesia, where 0=no nausea, 1=mild nausea, 2=moderate nausea, and 3=severe nausea | immediately pre-induction |
| Subject's Self-rated Intra-operative Nausea Level on a Scale of 0-3, Where 0=no Nausea, 1=Mild Nausea, 2=Moderate Nausea, and 3=Severe Nausea. | Subjects were asked to rate their nausea level on a scale of 0-3, where 0=no nausea, 1=mild nausea, 2=moderate nausea, and 3=severe nausea, five times during their procedure: 1) Immediately prior to skin incision, 2) immediately following delivery of the baby, 3) following reinternalization of the uterus, 4) following closure of the fascia, 5) following closure of the skin. The numbers given by the subject were then averaged to determine the average level of nausea intra-operatively for each subject. | intra-operation |
| Post-Operation Nausea Score | Subjects were asked to rate their nausea level on a scale of 0-3, where 0=no nausea, 1=mild nausea, 2=moderate nausea, and 3=severe nausea two times after the conclusion of their surgery: 1) upon arrival in the PACU, and 2) immediately prior to discharge from the PACU. The numbers given by the subject were then averaged to determine the average level of nausea post-operative for each subject. | post-operation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sharon Abramovitz, MD | Anesthesiology; Weill Medical College of Cornell - New York Presbyterian Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| New York-Presbyterian Hospital; Weill Medical College of Cornell | New York | New York | 10021 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34002866 | Derived | Griffiths JD, Gyte GM, Popham PA, Williams K, Paranjothy S, Broughton HK, Brown HC, Thomas J. Interventions for preventing nausea and vomiting in women undergoing regional anaesthesia for caesarean section. Cochrane Database Syst Rev. 2021 May 18;5(5):CD007579. doi: 10.1002/14651858.CD007579.pub3. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Saline Placebo | Saline Placebo: 0.5 mL, IM (in the muscle), one time |
| FG001 | IM Ephedrine | IM Ephedrine Ephedrine [Synonyms: Ephedra, Ephedrinum]: 25 mg, IM (in the muscle), one time |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Saline Placebo |
| Drug |
0.5 mL, IM (in the muscle), one time |
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| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Saline Placebo | Saline Placebo: 0.5 mL, IM (in the muscle), one time |
| BG001 | IM Ephedrine | IM Ephedrine Ephedrine [Synonyms: Ephedra, Ephedrinum]: 25 mg, IM (in the muscle), one time |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Pre-Induction Nausea Score | Subject's self-rated nausea level on a scale of 0-3 immediately prior to induction of spinal anesthesia, where 0=no nausea, 1=mild nausea, 2=moderate nausea, and 3=severe nausea | Posted | Mean | Standard Deviation | units on a scale | immediately pre-induction |
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| Primary | Subject's Self-rated Intra-operative Nausea Level on a Scale of 0-3, Where 0=no Nausea, 1=Mild Nausea, 2=Moderate Nausea, and 3=Severe Nausea. | Subjects were asked to rate their nausea level on a scale of 0-3, where 0=no nausea, 1=mild nausea, 2=moderate nausea, and 3=severe nausea, five times during their procedure: 1) Immediately prior to skin incision, 2) immediately following delivery of the baby, 3) following reinternalization of the uterus, 4) following closure of the fascia, 5) following closure of the skin. The numbers given by the subject were then averaged to determine the average level of nausea intra-operatively for each subject. | Posted | Mean | Standard Deviation | units on a scale | intra-operation |
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| Primary | Post-Operation Nausea Score | Subjects were asked to rate their nausea level on a scale of 0-3, where 0=no nausea, 1=mild nausea, 2=moderate nausea, and 3=severe nausea two times after the conclusion of their surgery: 1) upon arrival in the PACU, and 2) immediately prior to discharge from the PACU. The numbers given by the subject were then averaged to determine the average level of nausea post-operative for each subject. | Posted | Mean | Standard Deviation | units on a scale | post-operation |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Saline Placebo | Saline Placebo: 0.5 mL, IM (in the muscle), one time | 0 | 22 | 0 | 22 | 2 | 22 |
| EG001 | IM Ephedrine | IM Ephedrine Ephedrine [Synonyms: Ephedra, Ephedrinum]: 25 mg, IM (in the muscle), one time | 0 | 31 | 0 | 31 | 2 | 31 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Lightheadedness | General disorders | Systematic Assessment |
| ||
| Pruritis | General disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Michele Steinkamp, Research Nurse Specialist | Weill Cornell Medicine, Department of Anesthesiology | 212-746-2953 | mls9004@med.cornell.edu |
| ID | Term |
|---|---|
| D009325 | Nausea |
| D014839 | Vomiting |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D004809 | Ephedrine |
| ID | Term |
|---|---|
| D011412 | Propanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D020005 | Propanols |
| D000588 | Amines |
| D010627 | Phenethylamines |
| D005021 | Ethylamines |
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