Minimizing Nausea and Vomiting During Spinals for CS

NCT02872935 | Terminated Phase 4 Results DMC FDA Drug

• 1 other identifier: 201301793
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

Nausea; Vomiting

Outcome Measures

Primary Outcomes (2)

• Number of Participants Who Reported Nausea

  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.

  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

Study Arms (2)

Placebo: Normal Saline

PLACEBO COMPARATOR

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

Drug: Normal Saline

Glycopyrrolate group

EXPERIMENTAL

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

Drug: Glycopyrrolate

Interventions

Glycopyrrolate DRUG

.2mg of Glycopyrrolate will be given intravenously with the administration of the spinal dose

Also known as: Robinul

Glycopyrrolate group

Normal Saline DRUG

1ml of normal saline will be given intravenously with the administration of the spinal dose

Also known as: .9% saline

Placebo: Normal Saline

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Pregnant
• American Society of Anesthesiologists risk classification I and II
• Age \> 18 years
• Non-laboring
• Patients with elective cesarean sections

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kokila N Thenuwara: lead

Study Sites (1)

University of Iowa

Iowa City, Iowa, 52242, United States

Location

Related Publications (4)

• 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.

  PMID: 16192541 BACKGROUND

• 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.

  PMID: 10995148 BACKGROUND

• 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.

  PMID: 10823097 BACKGROUND

• 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.

  PMID: 34002866 DERIVED

MeSH Terms

Conditions

Nausea; Vomiting

Interventions

Glycopyrrolate; Saline Solution; Sodium Chloride

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quaternary Ammonium Compounds; Amines; Organic Chemicals; Onium Compounds; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Results Point of Contact

• Title: Dr. Kokila Thenuwara
• Organization: University of Iowa

kokila-thenuwara@uiowa.edu

319-384-5876

Study Officials

• Kokila N Thenuwara, MD

  University of Iowa

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Associate Professor

Study Record Dates

• First Submitted: August 5, 2016
• First Posted: August 19, 2016
• Study Start: May 15, 2015
• Primary Completion: November 30, 2016
• Study Completion: November 30, 2016
• Last Updated: June 9, 2020
• Results First Posted: June 9, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)