Efficacy of Ginger on Intraoperative and Postoperative Nausea and Vomiting in Elective Cesarean Section Patients

• Sponsor: Joel Yarmush (Other)
• Overall Status: Completed
• CT.gov ID: NCT01733212
• Collaborator: (none)
• Enrollment: 239
• Location: 1
• Arms: 2
• Duration (Months): 13
• Patients Per Site Per Month: 18.4

Study Details

Study Description

Brief 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.

• 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

Condition or Disease	Intervention/Treatment	Phase
Nausea; Vomiting	Drug: Ginger; Drug: Placebo Oral Tablet	Phase 2/Phase 3

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

• Study Type: Interventional
• Actual Enrollment: 239 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: Efficacy of Ginger on Intraoperative and Postoperative Nausea and Vomiting in Elective Cesarean Section Patients.
• Study Start Date: Jun 1, 2010
• Actual Primary Completion Date: Jul 1, 2011
• Actual Study Completion Date: Jul 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Ginger 2 gm powder of ginger filled in a capsule	Drug: Ginger; 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.; Other Names: Zingiber Officinale
Placebo Comparator: Placebo 2 gm of placebo pill (A capsule)	Drug: Placebo Oral Tablet; Two capsules (1g each) of placebo, one capsule a half-hour before induction of anesthesia and the second 2h after surgery.

Outcome Measures

Primary Outcome Measures

1. Occurrence of Intra-operative and Post-operative Vomiting [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 49 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Healthy (i.e., ASA I, or II) patients presenting for planned c-section at New York Methodist Hospital

• Signed informed consent

Exclusion Criteria:

• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	New York Methodist Hospital	Brooklyn	New York	United States	11215

Sponsors and Collaborators

• Joel Yarmush

Investigators

• Principal Investigator: Jonathan Weinberg, MD, New York Presbyterian Brooklyn Methodist Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Joel Yarmush, Attending Physician, Program Director (Anesthesiology), New York Presbyterian Brooklyn Methodist Hospital
• ClinicalTrials.gov Identifier: NCT01733212
• Other Study ID Numbers: IRB:147810
• First Posted: Nov 26, 2012
• Last Update Posted: Sep 10, 2021
• Last Verified: Aug 1, 2018

• Keywords provided by Joel Yarmush, Attending Physician, Program Director (Anesthesiology), New York Presbyterian Brooklyn Methodist Hospital: Nausea; Vomiting; Cesaraen; Ginger; cesarean section
• Additional relevant MeSH terms: Nausea; Vomiting; Postoperative Nausea and Vomiting

Study Results

Participant Flow

Recruitment Details	Enrollment period: June 03, 2010 to April 12, 2011 Location: New York Methodist Hospital, Department of Obstetrics and Gynecology

Arm/Group Title	Ginger	Placebo
Arm/Group Description	2 gm powder of ginger filled in a capsule	2 gm of placebo pill (A capsule)
Period Title: Overall Study
STARTED	116	123
COMPLETED	116	123
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Ginger	Placebo	Total
Arm/Group Description	2 gm powder of ginger filled in a capsule	2 gm of placebo pill (A capsule)	Total of all reporting groups
Overall Participants	116	123	239
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	116 100%	123 100%	239 100%
>=65 years	0 0%	0 0%	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	32.8 (5.3)	33.0 (4.8)	32.9 (5.0)
Sex: Female, Male (Count of Participants)
Female	116 100%	123 100%	239 100%
Male	0 0%	0 0%	0 0%
Region of Enrollment (participants) [Number]
United States	116 100%	123 100%	239 100%

Outcome Measures

1. Primary Outcome

Title	Occurrence of Intra-operative and Post-operative Vomiting
Description	Participants who had intra-operative and post-operative vomiting were identified and compared between the two groups.
Time Frame	During surgery (1 hour) and thru 72 hours after surgery

Outcome Measure Data

Analysis Population Description

Number of participants who had vomiting in each group is compared to the other group using Chi square test

Arm/Group Title	Ginger	Placebo
Arm/Group Description	2 gm powder of ginger filled in a capsule	2 gm of placebo pill (A capsule)
Measure Participants	116	123
Count of Participants [Participants]	30 25.9%	45 36.6%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Ginger, Placebo
	Comments	Number of participants who had vomiting in each group is compared to the other. Two sided Chi square test was conducted, Type I error of 0.05% and power of 80% are considered.
	Type of Statistical Test	Equivalence
	Comments	Considering the null hypothesis that the number of participants who will have vomiting will be equal in the two arms, we performed this study with a significance level of 0.05% and power of 80% to prove that there is a difference in the number.
Statistical Test of Hypothesis	p-Value	0.07
	Comments
	Method	Chi-squared
	Comments

Adverse Events

Arm/Group Title	Ginger		Placebo
Arm/Group Description	2 gm powder of ginger filled in a capsule		2 gm of placebo capsule
All Cause Mortality
	Ginger		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/116 (0%)		0/123 (0%)
Serious Adverse Events
	Ginger		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/116 (0%)		0/123 (0%)
Other (Not Including Serious) Adverse Events
	Ginger		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/116 (0%)		0/123 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.