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Trial record 9 of 186 for:    GLYCOPYRROLATE

Minimizing Nausea and Vomiting During Spinals for CS

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ClinicalTrials.gov Identifier: NCT02872935
Recruitment Status : Recruiting
First Posted : August 19, 2016
Last Update Posted : July 18, 2018
Sponsor:
Information provided by (Responsible Party):
Kokila N Thenuwara, University of Iowa

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.

Condition or disease Intervention/treatment Phase
Nausea Vomiting Drug: Glycopyrrolate Drug: Normal Saline Phase 4

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)


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : May 15, 2015
Estimated Primary Completion Date : December 31, 2018
Estimated Study Completion Date : December 31, 2018

Resource links provided by the National Library of Medicine


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 Name: .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 Name: Robinul




Primary Outcome Measures :
  1. Nausea will be measured using a Likert scale ranging from 0 no nausea to 10 the worst nausea Finally reduction in the severity of nausea in the treatment group will be assessed. [ Time Frame: From the administration of the spinal anesthesia to delivery of baby every 5 minutes, then till the end of the surgery during the cesarean section surgery, every 15minutes; Total time 90minutes ]
    Nausea Scale of 0-10 Vomiting Yes/No

  2. Vomiting will be assessed as yes /no. Finally a reduction in vomiting will be assessed in the treatment group. [ Time Frame: From the administration of the spinal anesthesia to delivery of baby every 5 minutes, then till the end of the surgery during the cesarean section surgery, every 15minutes; Total time 90minutes ]
    Vomiting yes/no


Secondary Outcome Measures :
  1. The lowest blood pressure during the time intervals that the nausea is recorded [ Time Frame: From the administration of the spinal anesthesia to delivery of baby every 5 minutes, then till the end of the surgery during the cesarean section surgery, every 15minutes; Total time 90minutes ]
    Blood pressure in MmHg Heart rate beats/minute

  2. The heart rate during the lowest blood pressure recorded. [ Time Frame: From the administration of the spinal anesthesia to delivery of baby every 5 minutes, then till the end of the surgery during the cesarean section surgery, every 15minutes; Total time 90minutes ]
    Heart rate in beats/minute



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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02872935


Contacts
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Contact: Kokila N Thenuwara, MD 319 541 8364 kokila-thenuwara@uiowa.edu

Locations
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United States, Iowa
University of Iowa Recruiting
Iowa City, Iowa, United States, 52242
Contact: Kokila N Thenuwara, MD    319-541-8634    kokila-thenuwara@uiowa.edu   
Principal Investigator: Kokila N Thenuwara, MD         
Sponsors and Collaborators
Kokila N Thenuwara
Investigators
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Principal Investigator: Kokila N Thenuwara, MD University of Iowa

Publications:
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Responsible Party: Kokila N Thenuwara, Clinical Associate Professor, University of Iowa
ClinicalTrials.gov Identifier: NCT02872935     History of Changes
Other Study ID Numbers: 201301793
First Posted: August 19, 2016    Key Record Dates
Last Update Posted: July 18, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Do not plan to share data

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Studies a U.S. FDA-regulated Drug Product: Yes
Additional relevant MeSH terms:
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Glycopyrrolate
Nausea
Vomiting
Signs and Symptoms, Digestive
Signs and Symptoms
Adjuvants, Anesthesia
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs