Minimizing Nausea and Vomiting During Spinals for CS

May 28, 2020 updated by: Kokila N Thenuwara

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

22

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • University of Iowa

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo: Normal Saline
1ml of Normal Saline will be given intravenously with the administering of the spinal dose
Drug: Normal Saline
1ml of normal saline will be given intravenously with the administration of the spinal dose
Other Names:
  • .9% saline
Experimental: Glycopyrrolate group
1ml of Glycopyrrolate ( .2mg /ml) will be given intravenously with the administering of the spinal dose
Drug: Glycopyrrolate
.2mg of Glycopyrrolate will be given intravenously with the administration of the spinal dose
Other Names:
  • Robinul

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants Who Reported Nausea
Time Frame: 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.
From the administration of the spinal anesthesia to delivery of baby - Total time 90minutes
Number of Participants Who Experienced Vomiting.
Time Frame: 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.
From the administration of the spinal anesthesia to delivery of baby; Total time 90minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kokila N Thenuwara

Investigators

  • Principal Investigator: Kokila N Thenuwara, MD, University of Iowa

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 15, 2015

Primary Completion (Actual)

November 30, 2016

Study Completion (Actual)

November 30, 2016

Study Registration Dates

First Submitted

August 5, 2016

First Submitted That Met QC Criteria

August 18, 2016

First Posted (Estimate)

August 19, 2016

Study Record Updates

Last Update Posted (Actual)

June 9, 2020

Last Update Submitted That Met QC Criteria

May 28, 2020

Last Verified

May 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 201301793

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Do not plan to share data

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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