NCT02872935

Minimizing Nausea and Vomiting During Spinals for CS

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

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: Kokila N Thenuwara · Academic / Other
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

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

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

• Nausea
• Vomiting

Interventions

Type	Name	Description
DRUG	Glycopyrrolate	.2mg of Glycopyrrolate will be given intravenously with the administration of the spinal dose
DRUG	Normal Saline	1ml of normal saline will be given intravenously with the administration of the spinal dose

Timeline

• Start date: 2015-05-15
• Primary completion: 2016-11-30
• Completion: 2016-11-30
• First posted: 2016-08-19
• Last updated: 2020-06-09
• Results posted: 2020-06-09

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study