Minimizing Nausea and Vomiting During Spinals for CS

Kokila N Thenuwara

Status and phase: Terminated; Phase 4

Conditions: Vomiting; Nausea

Treatments: Drug: Normal Saline; Drug: Glycopyrrolate

Study type: Interventional

Funder types: Other

Identifiers

NCT02872935

201301793

Details and patient eligibility

About

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.

Full description

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)

Enrollment: 22 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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22 participants in 2 patient groups, including a placebo group

Placebo: Normal Saline

Placebo Comparator group

Description:

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

Treatment:

Drug: Normal Saline

Glycopyrrolate group

Experimental group

Description:

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

Treatment:

Drug: Glycopyrrolate