Minimizing Nausea and Vomiting During Spinals for CS

Nausea Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02872935
• Other study ID #: 201301793
• Status: Terminated
• Phase: Phase 4
• Start date: May 15, 2015
• Est. completion date: November 30, 2016

Study information

• Verified date: May 2020
• Source: University of Iowa
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 22
• Est. completion date: November 30, 2016
• Est. primary completion date: November 30, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Nausea
• Vomiting

Intervention

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

Locations

Country	Name	City	State
United States	University of Iowa	Iowa City	Iowa

Sponsors (1)

Lead Sponsor	Collaborator
Kokila N Thenuwara

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View Citation

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):1182-7, table of contents. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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