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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT02872935
Other study ID # 201301793
Secondary ID
Status Terminated
Phase Phase 4
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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