Minimizing Nausea and Vomiting During Spinals for CS

Overview

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.

Full Title of Study: “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

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: November 30, 2016

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)

Interventions

  • Drug: Glycopyrrolate
    • .2mg of Glycopyrrolate will be given intravenously with the administration of the spinal dose
  • Drug: Normal Saline
    • 1ml of normal saline will be given intravenously with the administration of the spinal dose

Arms, Groups and Cohorts

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

Clinical Trial Outcome Measures

Primary Measures

  • 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.
  • 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.

Participating in This Clinical Trial

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.

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: 45 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Kokila N Thenuwara
  • Provider of Information About this Clinical Study
    • Sponsor-Investigator: Kokila N Thenuwara, Clinical Associate Professor – University of Iowa
  • Overall Official(s)
    • Kokila N Thenuwara, MD, Principal Investigator, University of Iowa

References

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.

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.

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.

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