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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

Tracking Information
First Submitted Date  ICMJE August 5, 2016
First Posted Date  ICMJE August 19, 2016
Last Update Posted Date July 18, 2018
Actual Study Start Date  ICMJE May 15, 2015
Estimated Primary Completion Date December 31, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 16, 2018)
  • 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
  • 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
Original Primary Outcome Measures  ICMJE
 (submitted: August 18, 2016)
  • Nausea will be measured using a Likert scale ranging from 1 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 ]
    Nausea Scale of 0-10 Vomiting Yes/No
  • 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 ]
    Vomiting yes/no
Change History Complete list of historical versions of study NCT02872935 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 18, 2016)
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: August 18, 2016)
  • 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 ]
    Blood pressure in MmHg Heart rate beats/minute
  • 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 ]
    Heart rate in beats/minute
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Minimizing Nausea and Vomiting During Spinals for CS
Official Title  ICMJE 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
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Nausea
  • Vomiting
Intervention  ICMJE
  • Drug: Glycopyrrolate
    .2mg of Glycopyrrolate will be given intravenously with the administration of the spinal dose
    Other Name: Robinul
  • Drug: Normal Saline
    1ml of normal saline will be given intravenously with the administration of the spinal dose
    Other Name: .9% saline
Study Arms  ICMJE
  • Placebo Comparator: Placebo: Normal Saline
    1ml of Normal Saline will be given intravenously with the administering of the spinal dose
    Intervention: Drug: Normal Saline
  • Experimental: Glycopyrrolate group
    1ml of Glycopyrrolate ( .2mg /ml) will be given intravenously with the administering of the spinal dose
    Intervention: Drug: Glycopyrrolate
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: August 18, 2016)
100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2018
Estimated Primary Completion Date December 31, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Kokila N Thenuwara, MD 319 541 8364 kokila-thenuwara@uiowa.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02872935
Other Study ID Numbers  ICMJE 201301793
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: Do not plan to share data
Responsible Party Kokila N Thenuwara, University of Iowa
Study Sponsor  ICMJE Kokila N Thenuwara
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Kokila N Thenuwara, MD University of Iowa
PRS Account University of Iowa
Verification Date July 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP