NauseaPhase 2/3NCT01733212
Efficacy of Ginger on Intraoperative and Postoperative Nausea and Vomiting in Elective Cesarean Section Patients
A Phase 2/3 study testing Ginger in people with Nausea and Vomiting, run by Joel Yarmush at 1 site in United States.
Trial summary
SPECIFIC AIMS Assess risk factors for nausea and vomiting in c-section patients undergoing regional anesthesia Quantify the incidence of nausea and vomiting intraoperatively and postoperatively in the ginger and placebo groups. Read more about this study
- Who is it for?
- Ages 20 to 49 years, women onlyHealthy volunteers can take part
- What is being tested?
- Ginger
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 239 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2010to Jul 2011
- Phase
- Phase 2/3
- 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 20 to 49 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy (i.e., ASA I, or II) patients presenting for planned c-section at New York Methodist Hospital
- Signed informed consent
Who cannot join
- They are unable or unwilling to take part in the study
- They have a history of an allergy to any medications used including ginger
- They have had any gastrointestinal surgery on the stomach, small intestine, or gall bladder.
- They have any history of bleeding disorder, (i.e., Hemophilia A/B, ITP, etc.)
- They have a contraindication to intrathecal or epidural anesthesia. ( i.e., Arnold- Chiari malformation, etc.)
- They are unable to understand instructions or questions related to study
- ASA III or IV patients
Trial locations and contacts
1 site in 1 country.
United States1 site
New York Methodist Hospital
Brooklyn, New York, 11215
About this study
Official title: Efficacy of Ginger on Intraoperative and Postoperative Nausea and Vomiting in Elective Cesarean Section Patients.
SPECIFIC AIMS
- Assess risk factors for nausea and vomiting in c-section patients undergoing regional anesthesia
- Quantify the incidence of nausea and vomiting intraoperatively and postoperatively in the ginger and placebo groups.
- Quantify post-operative analgesia and pruritus in the ginger and placebo groups
- Quantify patient satisfaction of the ginger and placebo groups
- Assess patient expectation of ginger on post-op day three
Read the detailed description
Two hundred and thirty nine ASA class I and II patients, scheduled for elective c-section will be assigned randomly to receive either 1g ginger tablet PO (Group 1) or 1 g placebo PO (Group 2) preoperatively, immediately before surgery. The usual preoperative anti-emetic and antacid regimen will be continued for both groups. Initial blood pressure, pulse and hemoglobin and hematocrit will be documented by the researcher prior to the arrival of the patient into the operating room. A baseline questionnaire will be given to the patients to assess risk factors for nausea and vomiting. Questions will include: age, BMI, parity, weeks gestation, h/o seasickness, h/o of hyperemesis gravidrum in this or prior pregnancies, h/o PONV, medical problems, any medication used within past 24 hrs, education and occupation.
Intraoperatively, both groups will receive combined spinal-epidural anesthesia in the usual manner. All standard monitoring will be applied and vital signs recorded for the entirety of the procedure. The number and dose of ephedrine or phenylephrine boluses and the number and severity of nausea episodes (using a Visual Analog Scale (VANS)) and number of vomiting episodes will be noted. In addition the following will be recorded: if uterus was exteriorized, any medications used by the anesthesiologist (other than ephedrine and phenylephrine), and estimated blood loss.
Postoperatively, patients will receive either a one time dose of the 1g ginger PO (Group 1) or 1 g placebo PO (Group 2) 2 hours after entering the postanesthesia care unit (PACU). Thirty minutes after the medication is given, patients will be asked to rate their nausea, level of analgesia, and level of pruritus on a VANS, and vomiting episodes will be recorded. Medications given for nausea will be continued in the post-operative period for both groups. The doses of Zofran will be counted in the 24 hr postoperative period. Twenty-four hours after surgery, blood will be drawn to assess hemoglobin and hematocrit as well as to assess platelet function.
- Being tested
- Ginger, Placebo Oral Tablet
- Keywords
- Nausea, Vomiting, Cesaraen, Ginger, cesarean section
- Medical subject headings
- Nausea, Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GingerDrug
Also called Zingiber Officinale
Ginger is an herb. The rhizome (underground stem) is used as a spice and also as a medicine. It can be used fresh, dried and powdered, or as a juice or oil. Two capsules (1g each) of dry powdered ginger are given, one capsule a half-hour before induction of anesthesia and the second 2h after surgery.
Placebo Oral TabletDrug
Two capsules (1g each) of placebo, one capsule a half-hour before induction of anesthesia and the second 2h after surgery.
| Study group | Role | What they receive |
|---|---|---|
| Ginger | Experimental | 2 gm powder of ginger filled in a capsule Receives: Drug: Ginger |
| Placebo | Placebo comparator | 2 gm of placebo pill (A capsule) Receives: Drug: Placebo Oral Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of Intra-operative and Post-operative Vomiting
Participants who had intra-operative and post-operative vomiting were identified and compared between the two groups.
Measured: During surgery (1 hour) and thru 72 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2012 (estimated)
- Study startJun 2010
- Primary completionJul 2011
- Study completionJul 2011
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 (2)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 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 239 participants (actual)
Sponsor and investigators
- Lead sponsor
- Joel Yarmush
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Joel Yarmush, New York Presbyterian Brooklyn Methodist Hospital
- Investigators
- Jonathan Weinberg, MD, Principal investigator, New York Presbyterian Brooklyn Methodist Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01733212
- Sponsor's protocol ID
- IRB:147810
- Status last verified
- Aug 2018
- First submitted
- 20 Nov 2012
- Last updated
- 10 Sep 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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.
PubMed 34002866Kalava A, Darji SJ, Kalstein A, Yarmush JM, SchianodiCola J, Weinberg J. Efficacy of ginger on intraoperative and postoperative nausea and vomiting in elective cesarean section patients. Eur J Obstet Gynecol Reprod Biol. 2013 Jul;169(2):184-8. doi: 10.1016/j.ejogrb.2013.02.014. Epub 2013 Mar 17.
PubMed 23510951
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Ginger on Intraoperative and Postoperative Nausea and Vomiting in Elective Cesarean Section Patients.
- ClinicalTrials.gov ID
- NCT01733212
- Acronym / sponsor ID
- IRB:147810
- Keywords
- Nausea, Vomiting, Cesaraen, Ginger, cesarean section
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 239 participants (actual)
- Lead sponsor
- Joel YarmushUniversity, hospital or other
- Study start
- Jun 2010
- Primary completion
- Jul 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 26 Nov 2012 (estimated)
- Results
- Posted 11 May 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
SPECIFIC AIMS
- Assess risk factors for nausea and vomiting in c-section patients undergoing regional anesthesia
- Quantify the incidence of nausea and vomiting intraoperatively and postoperatively in the ginger and placebo groups.
- Quantify post-operative analgesia and pruritus in the ginger and placebo groups
- Quantify patient satisfaction of the ginger and placebo groups
- Assess patient expectation of ginger on post-op day three
Detailed description
Two hundred and thirty nine ASA class I and II patients, scheduled for elective c-section will be assigned randomly to receive either 1g ginger tablet PO (Group 1) or 1 g placebo PO (Group 2) preoperatively, immediately before surgery. The usual preoperative anti-emetic and antacid regimen will be continued for both groups. Initial blood pressure, pulse and hemoglobin and hematocrit will be documented by the researcher prior to the arrival of the patient into the operating room. A baseline questionnaire will be given to the patients to assess risk factors for nausea and vomiting. Questions will include: age, BMI, parity, weeks gestation, h/o seasickness, h/o of hyperemesis gravidrum in this or prior pregnancies, h/o PONV, medical problems, any medication used within past 24 hrs, education and occupation.
Intraoperatively, both groups will receive combined spinal-epidural anesthesia in the usual manner. All standard monitoring will be applied and vital signs recorded for the entirety of the procedure. The number and dose of ephedrine or phenylephrine boluses and the number and severity of nausea episodes (using a Visual Analog Scale (VANS)) and number of vomiting episodes will be noted. In addition the following will be recorded: if uterus was exteriorized, any medications used by the anesthesiologist (other than ephedrine and phenylephrine), and estimated blood loss.
Postoperatively, patients will receive either a one time dose of the 1g ginger PO (Group 1) or 1 g placebo PO (Group 2) 2 hours after entering the postanesthesia care unit (PACU). Thirty minutes after the medication is given, patients will be asked to rate their nausea, level of analgesia, and level of pruritus on a VANS, and vomiting episodes will be recorded. Medications given for nausea will be continued in the post-operative period for both groups. The doses of Zofran will be counted in the 24 hr postoperative period. Twenty-four hours after surgery, blood will be drawn to assess hemoglobin and hematocrit as well as to assess platelet function.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ginger | Experimental | Drug: Ginger2 gm powder of ginger filled in a capsule |
| Placebo | Placebo comparator | Drug: Placebo Oral Tablet2 gm of placebo pill (A capsule) |
Who may qualify
- Ages
- 20 to 49 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy (i.e., ASA I, or II) patients presenting for planned c-section at New York Methodist Hospital
- Signed informed consent
Key exclusion criteria (7 listed)
- They are unable or unwilling to take part in the study
- They have a history of an allergy to any medications used including ginger
- They have had any gastrointestinal surgery on the stomach, small intestine, or gall bladder.
- They have any history of bleeding disorder, (i.e., Hemophilia A/B, ITP, etc.)
- They have a contraindication to intrathecal or epidural anesthesia. ( i.e., Arnold- Chiari malformation, etc.)
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 |
|---|---|---|
| GingerAlso: Zingiber OfficinaleGinger is an herb. The rhizome (underground stem) is used as a spice and also as a medicine. It can be used fresh, dried and powdered, or as a juice or oil. Two capsules (1g each) of dry powdered ginger are given, one capsule a half-hour before induction of anesthesia and the second 2h after surgery. | Drug | Ginger |
| Placebo Oral TabletTwo capsules (1g each) of placebo, one capsule a half-hour before induction of anesthesia and the second 2h after surgery. | Drug | Placebo |
Primary outcome
Occurrence of Intra-operative and Post-operative Vomiting
Time frame: During surgery (1 hour) and thru 72 hours after surgery
Participants who had intra-operative and post-operative vomiting were identified and compared between the two groups.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
- Derived from this study: PubMed 23510951Kalava A, Darji SJ, Kalstein A, Yarmush JM, SchianodiCola J, Weinberg J. Efficacy of ginger on intraoperative and postoperative nausea and vomiting in elective cesarean section patients. Eur J Obstet Gynecol Reprod Biol. 2013 Jul;169(2):184-8. doi: 10.1016/j.ejogrb.2013.02.014. Epub 2013 Mar 17.
Related trials for Nausea
Not yet recruitingPhase 2
Netupitant/Palonosetron for Prevention of Nausea and Vomiting in Breast Cancer ADC Therapy
Breast Cancer
RecruitingPhase 4
BMT-08: A Comparative Effectiveness Study of Transdermal Granisetron to Ondansetron
Nausea With Vomiting Chemotherapy-Induced
Not yet recruiting
Manual Acupuncture for Intradialytic Nausea and Vomiting in Patients Undergoing Hemodialysis
Intradialytic Nausea and Vomiting, Chronic Kidney Disease
Not yet recruitingObservational study
Preoperative Gastric Volume and PONV in Pediatric Appendectomy Cases
Postoperative Nausea and Vomiting
RecruitingPhase 2
A Study to Evaluate LY3537021 for the Treatment of Nausea and Vomiting Caused by Chemotherapy in Adults With Cancer
Nausea, Vomiting
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.
Jonathan Weinberg, MD principal investigator
New York Presbyterian Brooklyn Methodist Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Ginger in people with Nausea and Vomiting, run by Joel Yarmush 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 2 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: finished, as of the sponsor's last update on 10 Sep 2021. 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 11 May 2018). 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?
Occurrence of Intra-operative and Post-operative Vomiting (time frame: During surgery (1 hour) and thru 72 hours after surgery). 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 NCT01733212, which also lists 2 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 10 Sep 2021.