Minimizing Nausea and Vomiting During Spinals for CS

Study Results

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-05-15

Study Completion Date

2016-11-30

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.

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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)

Conditions

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Nausea Vomiting

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Placebo: Normal Saline

1ml of Normal Saline will be given intravenously with the administering of the spinal dose

Group Type PLACEBO_COMPARATOR

Normal Saline

Intervention Type DRUG

1ml of normal saline will be given intravenously with the administration of the spinal dose

Glycopyrrolate group

1ml of Glycopyrrolate ( .2mg /ml) will be given intravenously with the administering of the spinal dose

Group Type EXPERIMENTAL

Glycopyrrolate

Intervention Type DRUG

.2mg of Glycopyrrolate will be given intravenously with the administration of the spinal dose

Interventions

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Glycopyrrolate

.2mg of Glycopyrrolate will be given intravenously with the administration of the spinal dose

Intervention Type DRUG

Normal Saline

1ml of normal saline will be given intravenously with the administration of the spinal dose

Intervention Type DRUG

Other Intervention Names

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Robinul .9% saline

Eligibility Criteria

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Inclusion Criteria

1. Pregnant
2. American Society of Anesthesiologists risk classification I and II
3. Age \> 18 years
4. Non-laboring
5. Patients with elective cesarean sections

Exclusion Criteria

1. Non- English speakers
2. Height \< 4' 11"
3. BMI \>40 Kg/ mm
4. Antiemetic drug use in the 24 hours prior to cesarean delivery,
5. Hypertensive diseases of pregnancy
6. Chronic hypertension receiving antihypertensive treatment
7. Any other physical or psychiatric condition that may impair their ability to cooperate with study data collection.

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes