Minimizing Nausea and Vomiting During Spinals for CS

Phase 4TerminatedNCT02872935

Kokila N Thenuwara22 enrolled

Overview

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)

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Nausea Vomiting

Interventions

GlycopyrrolateDRUG

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

Normal SalineDRUG

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

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

University of Iowa

Iowa City, Iowa, United States

Outcomes

Primary Outcomes

Number of Participants Who Reported Nausea

Did the subject report nausea? The subject will respond with yes or no.

Time frame: 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.

Time frame: From the administration of the spinal anesthesia to delivery of baby; Total time 90minutes

Data from ClinicalTrials.gov

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