Minimizing Nausea and Vomiting During Spinals for CS



Status:Recruiting
Healthy:No
Age Range:18 - 45
Updated:7/20/2018
Start Date:May 15, 2015
End Date:December 31, 2018
Contact:Kokila N Thenuwara, MD
Email:kokila-thenuwara@uiowa.edu
Phone:319 541 8364

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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

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)

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.
We found this trial at
1
site
101 Jessup Hall
Iowa City, Iowa 52242
(319) 335-3500
Principal Investigator: Kokila N Thenuwara, MD
Phone: 319-541-8634
University of Iowa With just over 30,000 students, the University of Iowa is one of...
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