Minimizing Nausea and Vomiting During Spinals for CS

Phase 4

Terminated

• Conditions: Nausea; Vomiting
• Interventions: Drug: Normal Saline; Drug: Glycopyrrolate

• Registration Number: NCT02872935
• Lead Sponsor: Kokila N Thenuwara

Brief 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)

Study Timeline

• Study Start: 2015-05-15
• Study First Submitted: 2016-08-05
• Study First Submitted QC: 2016-08-18
• Study First Posted: 2016-08-19
• Primary Completion: 2016-11-30
• Study Completion: 2016-11-30
• Status Verified: 2020-05
• Results First Submitted: 2020-05-14
• Results First Submitted QC: 2020-05-28
• Last Update Submitted: 2020-05-28
• Results First Posted: 2020-06-09
• Last Update Posted: 2020-06-09

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 22

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo: Normal Saline	Normal Saline	1ml of Normal Saline will be given intravenously with the administering of the spinal dose
Glycopyrrolate group	Glycopyrrolate	1ml of Glycopyrrolate ( .2mg /ml) will be given intravenously with the administering of the spinal dose

Primary Outcome Measures

Name	Time	Method
Number of Participants Who Reported Nausea	From the administration of the spinal anesthesia to delivery of baby - Total time 90minutes	Did the subject report nausea? The subject will respond with yes or no.
Number of Participants Who Experienced Vomiting.	From the administration of the spinal anesthesia to delivery of baby; Total time 90minutes	This measure is observed by care team. Reported as vomiting, yes or no.

Trial Locations

Locations (1)

University of Iowa; 🇺🇸 Iowa City, Iowa, United States