NauseaPhase 4NCT02872935
Minimizing Nausea and Vomiting During Spinals for CS
A Phase 4 study testing Glycopyrrolate and Normal Saline in people with Nausea and Vomiting, run by Kokila N Thenuwara at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- What is being tested?
- Glycopyrrolate and Normal Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- 15 May 2015to 30 Nov 2016
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Pregnant
- American Society of Anesthesiologists risk classification I and II
- Age > 18 years
- Non-laboring
- Patients with elective cesarean sections
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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)
- Being tested
- Glycopyrrolate, Normal Saline
- Medical subject headings
- Nausea, Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GlycopyrrolateDrug
Also called Robinul
.2mg of Glycopyrrolate will be given intravenously with the administration of the spinal dose
Normal SalineDrug
Also called .9% saline
1ml of normal saline will be given intravenously with the administration of the spinal dose
| Study group | Role | What they receive |
|---|---|---|
| Placebo: Normal Saline | Placebo comparator | 1ml of Normal Saline will be given intravenously with the administering of the spinal dose Receives: Drug: Normal Saline |
| Glycopyrrolate group | Experimental | 1ml of Glycopyrrolate ( .2mg /ml) will be given intravenously with the administering of the spinal dose Receives: Drug: Glycopyrrolate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Who Reported Nausea
Did the subject report nausea? The subject will respond with yes or no.
Measured: 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.
Measured: From the administration of the spinal anesthesia to delivery of baby; Total time 90minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2016 (estimated)
- Study start15 May 2015
- Primary completion30 Nov 2016
- Study completion30 Nov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for NauseaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kokila N Thenuwara
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Kokila N Thenuwara, University of Iowa
- Investigators
- Kokila N Thenuwara, MD, Principal investigator, University of Iowa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02872935
- Sponsor's protocol ID
- 201301793
- Status last verified
- May 2020
- First submitted
- 5 Aug 2016
- Last updated
- 9 Jun 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- Individual data sharing
- No: Do not plan to share data
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.
PubMed 16192541Abouleish 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.
PubMed 10995148Harmon 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.
PubMed 10823097Griffiths 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.
PubMed 34002866
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02872935
- Acronym / sponsor ID
- 201301793
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Kokila N ThenuwaraUniversity, hospital or other
- Study start
- 15 May 2015 (actual)
- Primary completion
- 30 Nov 2016 (actual)
- Study completion
- 30 Nov 2016 (actual)
- First posted
- 19 Aug 2016 (estimated)
- Results
- Posted 9 Jun 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo: Normal Saline | Placebo comparator | Drug: Normal Saline1ml of Normal Saline will be given intravenously with the administering of the spinal dose |
| Glycopyrrolate group | Experimental | Drug: Glycopyrrolate1ml of Glycopyrrolate ( .2mg /ml) will be given intravenously with the administering of the spinal dose |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Pregnant
- American Society of Anesthesiologists risk classification I and II
- Age > 18 years
- Non-laboring
- Patients with elective cesarean sections
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GlycopyrrolateAlso: Robinul.2mg of Glycopyrrolate will be given intravenously with the administration of the spinal dose | Drug | Glycopyrrolate group |
| Normal SalineAlso: .9% saline1ml of normal saline will be given intravenously with the administration of the spinal dose | Drug | Placebo: Normal Saline |
Primary outcome
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 16192541Carvalho 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.
- Background: PubMed 10995148Abouleish 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.
- Background: PubMed 10823097Harmon 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.
- Derived from this study: PubMed 34002866Griffiths 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.
- Individual participant dataSharing planned: No. Do not plan to share data
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kokila N Thenuwara, MD principal investigator
University of Iowa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Glycopyrrolate and Normal Saline in people with Nausea and Vomiting, run by Kokila N Thenuwara at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 9 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Jun 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Who Reported Nausea (time frame: From the administration of the spinal anesthesia to delivery of baby - Total time 90minutes). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02872935, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2020.