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In parturients undergoing Cesarean section under spinal anesthesia, co-loading of 1 liter of crystalloids, with placing the spinal, along with administering a phenylephrine infusion and glycopyrrolate, enables placing a spinal with minimal perioperative nausea and vomiting and good intra and post-operative pain relief.
The hypothesis of this study is as follows: In parturients undergoing Cesarean section under spinal anesthesia, co-loading of 1 liter of crystalloids, with placing the spinal, along with administering a phenylephrine infusion and glycopyrrolate, enables placing a spinal with minimal perioperative nausea and vomiting and good intra and post-operative pain relief.
The study group will receive phenylephrine infusion [dilution 100micrograms /cc] Rate of infusion 50micrograms /hour, approximately 30ml/hour To be started immediately after the placement of the spinal anesthetic Patient will also be given .4mg [1cc of glycopyrrolate], with the starting of the infusion
The control group, will receive phenylephrine infusion [dilution 100micrograms /cc] Rate of infusion 50micrograms /hour, approximately 30ml/hour To be started immediately after the placement of the spinal anesthetic Patient will also be given a placebo [1cc of N saline], with the starting of the infusion
Following the administration of the study drug/placebo, the patient will be monitored for severity of nausea , vomiting and pain at 5 minutes intervals from placement of the spinal to delivery of the baby, and then at 15 minutes intervals from delivery of the baby till the end of the surgery ( the cesarean section)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo: Normal Saline | Placebo Comparator | 1ml of Normal Saline will be given intravenously with the administering of the spinal dose |
|
| Glycopyrrolate group | Experimental | 1ml of Glycopyrrolate ( .2mg /ml) will be given intravenously with the administering of the spinal dose |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Glycopyrrolate | Drug | .2mg of Glycopyrrolate will be given intravenously with the administration of the spinal dose |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Reported Nausea | Did the subject report nausea? The subject will respond with yes or no. | From the administration of the spinal anesthesia to delivery of baby - Total time 90minutes |
| Number of Participants Who Experienced Vomiting. | This measure is observed by care team. Reported as vomiting, yes or no. | From the administration of the spinal anesthesia to delivery of baby; Total time 90minutes |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kokila N Thenuwara, MD | University of Iowa | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Iowa | Iowa City | Iowa | 52242 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16192541 | Background | Carvalho B, Cohen SE, Lipman SS, Fuller A, Mathusamy AD, Macario A. Patient preferences for anesthesia outcomes associated with cesarean delivery. Anesth Analg. 2005 Oct;101(4):1182-1187. doi: 10.1213/01.ane.0000167774.36833.99. | |
| 10995148 | Background | Abouleish EI, Rashid S, Haque S, Giezentanner A, Joynton P, Chuang AZ. Ondansetron versus placebo for the control of nausea and vomiting during Caesarean section under spinal anaesthesia. Anaesthesia. 1999 May;54(5):479-82. doi: 10.1046/j.1365-2044.1999.00798.x. |
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Do not plan to share data
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo: Normal Saline | 1ml of Normal Saline will be given intravenously with the administering of the spinal dose Normal Saline: 1ml of normal saline will be given intravenously with the administration of the spinal dose |
| FG001 | Glycopyrrolate Group | 1ml of Glycopyrrolate ( .2mg /ml) will be given intravenously with the administering of the spinal dose Glycopyrrolate: .2mg of Glycopyrrolate will be given intravenously with the administration of the spinal dose |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo: Normal Saline | 1ml of Normal Saline will be given intravenously with the administering of the spinal dose Normal Saline: 1ml of normal saline will be given intravenously with the administration of the spinal dose |
| BG001 | Glycopyrrolate Group |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Number of Participants Who Reported Nausea | Did the subject report nausea? The subject will respond with yes or no. | Posted | Count of Participants | Participants | From the administration of the spinal anesthesia to delivery of baby - Total time 90minutes |
|
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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 | Placebo: Normal Saline | 1ml of Normal Saline will be given intravenously with the administering of the spinal dose Normal Saline: 1ml of normal saline will be given intravenously with the administration of the spinal dose |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Kokila Thenuwara | University of Iowa | 319-384-5876 | kokila-thenuwara@uiowa.edu |
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| 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 |
|---|---|
| D006024 | Glycopyrrolate |
| D000077330 | Saline Solution |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D000644 | Quaternary Ammonium Compounds |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D009861 | Onium Compounds |
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| Normal Saline | Drug | 1ml of normal saline will be given intravenously with the administration of the spinal dose |
|
|
| 10823097 | Background | Harmon D, Ryan M, Kelly A, Bowen M. Acupressure and prevention of nausea and vomiting during and after spinal anaesthesia for caesarean section. Br J Anaesth. 2000 Apr;84(4):463-7. doi: 10.1093/oxfordjournals.bja.a013471. |
| 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. |
1ml of Glycopyrrolate ( .2mg /ml) will be given intravenously with the administering of the spinal dose Glycopyrrolate: .2mg of Glycopyrrolate will be given intravenously with the administration of the spinal dose |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| 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 |
|
|
|
| Primary | Number of Participants Who Experienced Vomiting. | This measure is observed by care team. Reported as vomiting, yes or no. | Posted | Count of Participants | Participants | From the administration of the spinal anesthesia to delivery of baby; Total time 90minutes |
|
|
|
| 0 |
| 11 |
| 0 |
| 11 |
| EG001 | Glycopyrrolate Group | 1ml of Glycopyrrolate ( .2mg /ml) will be given intravenously with the administering of the spinal dose Glycopyrrolate: .2mg of Glycopyrrolate will be given intravenously with the administration of the spinal dose | 0 | 11 | 0 | 11 |
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| D011759 |
| Pyrrolidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |