Minimizing Nausea and Vomiting During Spinals for CS

• ClinicalTrials.gov Identifier: NCT02872935
• Recruitment Status: Terminated
• First Posted: August 19, 2016
• Results First Posted: June 9, 2020
• Last Update Posted: June 9, 2020
• Sponsor: Kokila N Thenuwara
• Information provided by (Responsible Party): Kokila N Thenuwara, University of Iowa

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.

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)

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 22 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
• Actual Primary Completion Date: November 30, 2016
• Actual Study Completion Date: November 30, 2016

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. 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.
2. 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.

Eligibility Criteria

• 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.

Contacts and Locations

Locations

United States, Iowa

University of Iowa

Iowa City, Iowa, United States, 52242

Sponsors and Collaborators

Kokila N Thenuwara

Investigators

• Principal Investigator: Kokila N Thenuwara, MD; University of Iowa

More Information

Publications:

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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Kokila N Thenuwara, Clinical Associate Professor, University of Iowa
• ClinicalTrials.gov Identifier: NCT02872935
• Other Study ID Numbers: 201301793
• First Posted: August 19, 2016
• Results First Posted: June 9, 2020
• Last Update Posted: June 9, 2020
• Last Verified: May 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No
• Plan Description: Do not plan to share data

• Studies a U.S. FDA-regulated Drug Product: Yes

Additional relevant MeSH terms:

Nausea; Vomiting; Signs and Symptoms, Digestive; Glycopyrrolate; Adjuvants, Anesthesia; Muscarinic Antagonists; Cholinergic Antagonists; Cholinergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Physiological Effects of Drugs