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Minimizing Nausea and Vomiting During Spinals for CS

Primary Purpose

Nausea, Vomiting

Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Glycopyrrolate
Normal Saline
Sponsored by
Kokila N Thenuwara
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Nausea

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleAccepts 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.

Sites / Locations

  • University of Iowa

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo: Normal Saline

Glycopyrrolate group

Arm Description

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

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

Outcomes

Primary Outcome Measures

Number of Participants Who Reported Nausea
Did the subject report nausea? The subject will respond with yes or no.
Number of Participants Who Experienced Vomiting.
This measure is observed by care team. Reported as vomiting, yes or no.

Secondary Outcome Measures

Full Information

First Posted
August 5, 2016
Last Updated
May 28, 2020
Sponsor
Kokila N Thenuwara
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1. Study Identification

Unique Protocol Identification Number
NCT02872935
Brief Title
Minimizing Nausea and Vomiting During Spinals for CS
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2020
Overall Recruitment Status
Terminated
Study Start Date
May 15, 2015 (Actual)
Primary Completion Date
November 30, 2016 (Actual)
Study Completion Date
November 30, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Kokila N Thenuwara

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Data Monitoring Committee
Yes

5. Study Description

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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nausea, Vomiting

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
22 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo: Normal Saline
Arm Type
Placebo Comparator
Arm Description
1ml of Normal Saline will be given intravenously with the administering of the spinal dose
Arm Title
Glycopyrrolate group
Arm Type
Experimental
Arm Description
1ml of Glycopyrrolate ( .2mg /ml) will be given intravenously with the administering of the spinal dose
Intervention Type
Drug
Intervention Name(s)
Glycopyrrolate
Other Intervention Name(s)
Robinul
Intervention Description
.2mg of Glycopyrrolate will be given intravenously with the administration of the spinal dose
Intervention Type
Drug
Intervention Name(s)
Normal Saline
Other Intervention Name(s)
.9% saline
Intervention Description
1ml of normal saline will be given intravenously with the administration of the spinal dose
Primary Outcome Measure Information:
Title
Number of Participants Who Reported Nausea
Description
Did the subject report nausea? The subject will respond with yes or no.
Time Frame
From the administration of the spinal anesthesia to delivery of baby - Total time 90minutes
Title
Number of Participants Who Experienced Vomiting.
Description
This measure is observed by care team. Reported as vomiting, yes or no.
Time Frame
From the administration of the spinal anesthesia to delivery of baby; Total time 90minutes

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Pregnant American Society of Anesthesiologists risk classification I and II Age > 18 years Non-laboring Patients with elective cesarean sections Exclusion Criteria: Non- English speakers Height < 4' 11" BMI >40 Kg/ mm Antiemetic drug use in the 24 hours prior to cesarean delivery, Hypertensive diseases of pregnancy Chronic hypertension receiving antihypertensive treatment Any other physical or psychiatric condition that may impair their ability to cooperate with study data collection.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kokila N Thenuwara, MD
Organizational Affiliation
University of Iowa
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Iowa
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Do not plan to share data
Citations:
PubMed Identifier
16192541
Citation
Carvalho B, Cohen SE, Lipman SS, Fuller A, Mathusamy AD, Macario A. Patient preferences for anesthesia outcomes associated with cesarean delivery. Anesth Analg. 2005 Oct;101(4):1182-1187. doi: 10.1213/01.ane.0000167774.36833.99.
Results Reference
background
PubMed Identifier
10995148
Citation
Abouleish EI, Rashid S, Haque S, Giezentanner A, Joynton P, Chuang AZ. Ondansetron versus placebo for the control of nausea and vomiting during Caesarean section under spinal anaesthesia. Anaesthesia. 1999 May;54(5):479-82. doi: 10.1046/j.1365-2044.1999.00798.x.
Results Reference
background
PubMed Identifier
10823097
Citation
Harmon D, Ryan M, Kelly A, Bowen M. Acupressure and prevention of nausea and vomiting during and after spinal anaesthesia for caesarean section. Br J Anaesth. 2000 Apr;84(4):463-7. doi: 10.1093/oxfordjournals.bja.a013471.
Results Reference
background
PubMed Identifier
34002866
Citation
Griffiths JD, Gyte GM, Popham PA, Williams K, Paranjothy S, Broughton HK, Brown HC, Thomas J. Interventions for preventing nausea and vomiting in women undergoing regional anaesthesia for caesarean section. Cochrane Database Syst Rev. 2021 May 18;5(5):CD007579. doi: 10.1002/14651858.CD007579.pub3.
Results Reference
derived

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Minimizing Nausea and Vomiting During Spinals for CS

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