Minimizing Nausea and Vomiting During Spinals for CS

Study Overview
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Brief Summary
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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.

Detailed Description
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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)

Official Title
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Randomized Double Control Study to Assess the Efficacy of Administering 1 ml of Glycopyrrolate With the Spinal Dose in Minimizing Nausea and Vomiting in Patients Undergoing Cesarean Section Under Spinal Anesthesia

Conditions
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Vomiting, Nausea

Intervention / Treatment
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* Drug: Glycopyrrolate
* Drug: Normal Saline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Pregnant American Society of Anesthesiologists risk classification I and II Age > 18 years Non-laboring Patients with elective cesarean sections Exclusion Criteria: Non- English speakers Height < 4' 11 BMI >40 Kg/ mm Antiemetic drug use in the 24 hours prior to cesarean delivery, Hypertensive diseases of pregnancy Chronic hypertension receiving antihypertensive treatment Any other physical or psychiatric condition that may impair their ability to cooperate with study data collection.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo: Normal Saline<br>1ml of Normal Saline will be given intravenously with the administering of the spinal dose | Drug: Normal Saline<br>* 1ml of normal saline will be given intravenously with the administration of the spinal dose<br>* Other names: .9% saline;|
| Experimental: Glycopyrrolate group<br>1ml of Glycopyrrolate ( .2mg /ml) will be given intravenously with the administering of the spinal dose | Drug: Glycopyrrolate<br>* .2mg of Glycopyrrolate will be given intravenously with the administration of the spinal dose<br>* Other names: Robinul;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 |