NauseaPhase 4NCT02960113
Scopolamine Patch and Acupressure Point P6 Stimulation for Reduction of Nausea and Vomiting During Cesarean Section
A Phase 4 study testing scopolamine patch and acupressure point P6 in people with Nausea and Vomiting, run by Rutgers, The State University of New Jersey at 1 site in United States.
Trial summary
The purpose of this study is to compare the effectiveness of reducing intra-cesarean section nausea and vomiting with regional anesthesia in subjects who will receive scopolamine patch with acupressure point P6 stimulation versus subjects that receive just scopolamine patch versus subjects that receive just… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Nausea, Vomiting, Satisfaction
- What is being tested?
- scopolamine patch and acupressure point P6
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteUnited States
- Study dates
- May 2016to Sep 2021
- 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
- Female subjects ages 18 to 45
- Subjects with ASA Class I or II
- Subjects with elective primary or repeat cesarean delivery
- Subjects who receive spinal and/or epidural anesthesia
- English and non-English speaking subjects will be included in the study
Who cannot join
- Female subjects <18 years of age
- Subjects requiring emergent cesarean delivery
- Gestational age < 37 weeks
- History of placenta accreta
- Multiple gestation pregnancy
- ASA status III or higher
Show all 11Show fewer
- Current history of pregnancy induced hypertension, pre-eclampsia, or eclampsia
- History of any chronic medication use (other than prenatal vitamins), including inhaler medications
- Current urinary tract infection, pneumonia, or otitis media
- Coagulopathies or skin infections overlying the spine
- History of open angle glaucoma, seizures or psychosis
Trial locations and contacts
1 site in 1 country.
United States1 site
Robert Wood Johnson University Hospital
New Brunswick, New Jersey, 08901
About this study
Official title: Is the Application of Scopolamine Patch With or Without Intra-operative Acupressure Point P6 Stimulation More Effective Than Intra-operative Acupressure Point P6 Stimulation Alone?
The purpose of this study is to compare the effectiveness of reducing intra-cesarean section nausea and vomiting with regional anesthesia in subjects who will receive scopolamine patch with acupressure point P6 stimulation versus subjects that receive just scopolamine patch versus subjects that receive just acupressure point P6 stimulation.
Read the detailed description
Nausea and vomiting are very common and unpleasant events experienced during cesarean section under regional anesthesia and in the postoperative period following cesarean section. These side effects are distressing for both the parturient and her family. In addition, intraoperative vomiting causes significant challenges for the surgeon, such as increased procedure length, increased risk of bleeding, increased risk of gastric content aspiration, and potential surgical trauma.
To combat the nausea and vomiting seen in all above anesthetic modalities, but to a greater degree in regional anesthesia, a number of pharmacological interventions are currently used with varying degrees of effectiveness in the perioperative period. These medications come from a wide range of drug classes including serotonin and dopamine receptor antagonists, corticosteroids, antihistamines, sedatives and anticholinergics.
In our study, we would like to compare the effectiveness of antiemetic agents or technique which cause less severe adverse reactions to the mother and her fetus. Out of the available pharmacological agents for reduction of intra-cesarean section nausea and vomiting, transdermal scopolamine patch is one of the safest medications. We would like to compare the effectiveness of the transdermal scopolamine patch with acupressure point P6 stimulation versus just transdermal scopolamine patch versus just acupressure point P6 stimulation.
- Conditions
- Nausea, Vomiting, Satisfaction
- Being tested
- scopolamine patch, acupressure point P6
- Keywords
- cesarean section, acupressure point p6, scopolamine patch
- Medical subject headings
- Nausea, Vomiting, Personal Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
scopolamine patchDrug
Also called Transderm-Scop, Scopace, Maldemar
Group I (n=80): Will receive scopolamine patch placement on the skin behind the right ear 1 hour before initiation of the regional anesthesia for the duration of surgery. The time of the application of the patch will be recorded, and the time of the start of the surgery will be recorded. The last time point for evaluation of patient's nausea/vomiting will be when the patient arrives to the post anesthesia care unit. A member of the research team will remove the patch from the patient and properly dispose the patch upon arrival to the post anesthesia care unit.
acupressure point P6Device
Group II (n=80): Will receive acupressure point P6 stimulation. This is a stimulation of the chi channel at the master of the heart (MH8 position) at the small depression of the volar surface of the distal right forearm just above the crest of the wrist. The device will be put on the patients in the operating room prior to administration of the regional anesthesia and will be removed after the cesarean section is complete. The device will be removed from the patient in the operating room, before the patient is transported to the recovery room. Patients will receive continuous stimulation at a level that is comfortable for her prior to administration of the standardized regional anesthesia.
| Study group | Role | What they receive |
|---|---|---|
| scopolamine patch | Experimental | Scopolamine patch will be placed on the skin behind the right ear 1 hour before initiation of the regional anesthesia for the duration of surgery. Receives: Drug: scopolamine patch |
| acupressure point P6 | Experimental | Acupressure point P6 stimulation will be placed on the distal right forearm just above the crest of the wrist. Receives: Device: acupressure point P6 |
| scopolamine patch + acupressure point P6 | Experimental | Will receive both scopolamine patch and acupressure point P6 stimulation, as described above. Receives: Drug: scopolamine patch; Device: acupressure point P6 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Patients With Nausea
The investigators will analyze if there is a statistically significant difference between the number of patients that experience nausea at any point during the surgical procedure in each group.
Measured: Throughout the entire surgical procedure
Number of Patients With Vomiting
The investigators will perform objective assessments of whether or not the patients have vomited during the procedure. The investigators will then analyze if there is a statistically significant difference between the number of patients that vomit in each group.
Measured: Throughout the surgical procedure
Secondary outcomes (9)
Satisfaction With Intraoperative Antiemetic Treatment
Patients are asked their nausea and vomiting treatment satisfaction (0 = Not Satisfied, 10 = Extremely Satisfied). Patients are also asked their overall satisfaction with the procedure (0 = Not Satisfied, 10 = Extremely Satisfied).
Measured: Throughout the surgical procedure
Level of Nausea After the Administration of the Regional Anesthesia Medications
Patients offer their subjective assessments of the level of nausea on a scale of 0-10 (0 = no nausea, 10 = worst nausea ever experienced) after the administration of the regional anesthesia medications. The investigators will analyze if there is a statistically significant difference between the number of patients that experience nausea in each group at this point. Patients that report nausea (1 or more on our scale) will be recorded as that they have experienced nausea.
Measured: From administration of anaesthesia until eversion of uterus
Level of Nausea After Eversion of the Uterus
Patients offer their subjective assessments of the level of nausea on a scale of 0-10 (0 = no nausea, 10 = worst nausea ever experienced) after eversion of the uterus. The investigators will analyze if there is a statistically significant difference between the number of patients that experience nausea in each group at this point. Patients that report nausea (1 or more on our scale) will be recorded as that they have experienced nausea.
Measured: After eversion of the uterus until replacement of the uterus
Level of Nausea After Replacement of the Uterus
Patients offer their subjective assessments of the level of nausea on a scale of 0-10 (0 = no nausea, 10 = worst nausea ever experienced) after replacement of the uterus. The investigators will analyze if there is a statistically significant difference between the number of patients that experience nausea in each group at this point. Patients that report nausea (1 or more on our scale) will be recorded as that they have experienced nausea.
Measured: After replacement of the uterus and to the next 15 minutes
Level of Nausea Upon Arrival to the Post-operative Recovery Room
Patients offer their subjective assessments of the level of nausea on a scale of 0-10 (0 = no nausea, 10 = worst nausea ever experienced) upon arrival to the post-operative recovery room. The investigators will analyze if there is a statistically significant difference between the number of patients that experience nausea in each group at this point. Patients that report nausea (1 or more on our scale) will be recorded as that they have experienced nausea.
Measured: 15 minutes after replacement of the uterus to arrival at post-anaesthesia care unit
Number of Patients With Vomiting After the Administration of the Regional Anesthesia Medications
Objective assessments of whether or not the patients have vomited at this point in the surgical procedure will be done. The investigators will analyze if there is a statistically significant difference between the number of patients that vomit in each group.
Measured: After the administration of the regional anesthesia medications until eversion of the uterus
Number of Patients With Vomiting After Eversion of the Uterus
Objective assessments of whether or not the patients have vomited at this point in the surgical procedure will be done. The investigators will analyze if there is a statistically significant difference between the number of patients that vomit in each group.
Measured: After eversion of to replacement of the uterus
Number of Patients With Vomiting After Replacement of the Uterus
Objective assessments of whether or not the patients have vomited at this point in the surgical procedure will be done. The investigators will analyze if there is a statistically significant difference between the number of patients that vomit in each group.
Measured: After replacement of the uterus and for next 15 minutes
Number of Patients With Vomiting Upon Arrival to the Post-operative Recovery Room
Objective assessments of whether or not the patients have vomited at this point in the surgical procedure will be done. The investigators will analyze if there is a statistically significant difference between the number of patients that vomit in each group.
Measured: From 15 minutes after replacement of the uterus until arrival at the post-anaesthesia care unit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2016 (estimated)
- Study startMay 2016
- Primary completionSep 2021
- Study completionSep 2021
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 (16)Papers the sponsor has linked to this study.
- Other trials for NauseaStudies of the same condition, open and under way.
- More trials run by Rutgers, The State University of New JerseyThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rutgers, The State University of New Jersey
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shaul Cohen, M.D., Rutgers, The State University of New Jersey
- Investigators
- Shaul Cohen, MD, Principal investigator, Robert Wood Johnson University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02960113
- Sponsor's protocol ID
- Pro20160000234
- Status last verified
- Nov 2022
- First submitted
- 7 Nov 2016
- Last updated
- 28 Dec 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Hawkins JL, Koonin LM, Palmer SK, Gibbs CP. Anesthesia-related deaths during obstetric delivery in the United States, 1979-1990. Anesthesiology. 1997 Feb;86(2):277-84. doi: 10.1097/00000542-199702000-00002.
PubMed 9054245Ezri T, Szmuk P, Evron S, Geva D, Hagay Z, Katz J. Difficult airway in obstetric anesthesia: a review. Obstet Gynecol Surv. 2001 Oct;56(10):631-41. doi: 10.1097/00006254-200110000-00022.
PubMed 11590314Malvasi A, Tinelli A, Stark M, Pontrelli G, Brizzi A, Wetzl RG, Benhamou D. Low-dose sequential combined spinal-epidural anaesthesia in elective Stark caesarean section: a preliminary cohort study. Eur Rev Med Pharmacol Sci. 2010 Mar;14(3):215-21.
PubMed 20391961Afolabi BB, Lesi FE. Regional versus general anaesthesia for caesarean section. Cochrane Database Syst Rev. 2012 Oct 17;10(10):CD004350. doi: 10.1002/14651858.CD004350.pub3.
PubMed 23076903Riley ET, Cohen SE, Macario A, Desai JB, Ratner EF. Spinal versus epidural anesthesia for cesarean section: a comparison of time efficiency, costs, charges, and complications. Anesth Analg. 1995 Apr;80(4):709-12. doi: 10.1097/00000539-199504000-00010.
PubMed 7893022Balki M, Carvalho JC. Intraoperative nausea and vomiting during cesarean section under regional anesthesia. Int J Obstet Anesth. 2005 Jul;14(3):230-41. doi: 10.1016/j.ijoa.2004.12.004.
PubMed 15935649Paranjothy S, Griffiths JD, Broughton HK, Gyte GM, Brown HC, Thomas J. Interventions at caesarean section for reducing the risk of aspiration pneumonitis. Cochrane Database Syst Rev. 2014 Feb 5;2014(2):CD004943. doi: 10.1002/14651858.CD004943.pub4.
PubMed 24497372Flake ZA, Linn BS, Hornecker JR. Practical selection of antiemetics in the ambulatory setting. Am Fam Physician. 2015 Mar 1;91(5):293-6.
PubMed 25822385Golembiewski J, Chernin E, Chopra T. Prevention and treatment of postoperative nausea and vomiting. Am J Health Syst Pharm. 2005 Jun 15;62(12):1247-60; quiz 1261-2. doi: 10.1093/ajhp/62.12.1247.
PubMed 15947124Apfel CC, Zhang K, George E, Shi S, Jalota L, Hornuss C, Fero KE, Heidrich F, Pergolizzi JV, Cakmakkaya OS, Kranke P. Transdermal scopolamine for the prevention of postoperative nausea and vomiting: a systematic review and meta-analysis. Clin Ther. 2010 Nov;32(12):1987-2002. doi: 10.1016/j.clinthera.2010.11.014.
PubMed 21118734Renner UD, Oertel R, Kirch W. Pharmacokinetics and pharmacodynamics in clinical use of scopolamine. Ther Drug Monit. 2005 Oct;27(5):655-65. doi: 10.1097/01.ftd.0000168293.48226.57.
PubMed 16175141Lee A, Fan LT. Stimulation of the wrist acupuncture point P6 for preventing postoperative nausea and vomiting. Cochrane Database Syst Rev. 2009 Apr 15;(2):CD003281. doi: 10.1002/14651858.CD003281.pub3.
PubMed 19370583Allen TK, Habib AS. P6 stimulation for the prevention of nausea and vomiting associated with cesarean delivery under neuraxial anesthesia: a systematic review of randomized controlled trials. Anesth Analg. 2008 Oct;107(4):1308-12. doi: 10.1213/ane.0b013e31816d1864.
PubMed 18806045Quinla JD, Hill DA. Nausea and vomiting of pregnancy. Am Fam Physician. 2003 Jul 1;68(1):121-8.
PubMed 12887118Belluomini J, Litt RC, Lee KA, Katz M. Acupressure for nausea and vomiting of pregnancy: a randomized, blinded study. Obstet Gynecol. 1994 Aug;84(2):245-8.
PubMed 8041539
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is the Application of Scopolamine Patch With or Without Intra-operative Acupressure Point P6 Stimulation More Effective Than Intra-operative Acupressure Point P6 Stimulation Alone?
- ClinicalTrials.gov ID
- NCT02960113
- Acronym / sponsor ID
- Pro20160000234
- Conditions
- Nausea, Vomiting, Satisfaction
- Keywords
- cesarean section, acupressure point p6, scopolamine patch
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- Rutgers, The State University of New JerseyUniversity, hospital or other
- Study start
- May 2016 (actual)
- Primary completion
- Sep 2021 (actual)
- Study completion
- Sep 2021 (actual)
- First posted
- 9 Nov 2016 (estimated)
- Results
- Posted 28 Dec 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to compare the effectiveness of reducing intra-cesarean section nausea and vomiting with regional anesthesia in subjects who will receive scopolamine patch with acupressure point P6 stimulation versus subjects that receive just scopolamine patch versus subjects that receive just acupressure point P6 stimulation.
Detailed description
Nausea and vomiting are very common and unpleasant events experienced during cesarean section under regional anesthesia and in the postoperative period following cesarean section. These side effects are distressing for both the parturient and her family. In addition, intraoperative vomiting causes significant challenges for the surgeon, such as increased procedure length, increased risk of bleeding, increased risk of gastric content aspiration, and potential surgical trauma.
To combat the nausea and vomiting seen in all above anesthetic modalities, but to a greater degree in regional anesthesia, a number of pharmacological interventions are currently used with varying degrees of effectiveness in the perioperative period. These medications come from a wide range of drug classes including serotonin and dopamine receptor antagonists, corticosteroids, antihistamines, sedatives and anticholinergics.
In our study, we would like to compare the effectiveness of antiemetic agents or technique which cause less severe adverse reactions to the mother and her fetus. Out of the available pharmacological agents for reduction of intra-cesarean section nausea and vomiting, transdermal scopolamine patch is one of the safest medications. We would like to compare the effectiveness of the transdermal scopolamine patch with acupressure point P6 stimulation versus just transdermal scopolamine patch versus just acupressure point P6 stimulation.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| scopolamine patch | Experimental | Drug: scopolamine patchScopolamine patch will be placed on the skin behind the right ear 1 hour before initiation of the regional anesthesia for the duration of surgery. |
| acupressure point P6 | Experimental | Device: acupressure point P6Acupressure point P6 stimulation will be placed on the distal right forearm just above the crest of the wrist. |
| scopolamine patch + acupressure point P6 | Experimental | Drug: scopolamine patch, Device: acupressure point P6Will receive both scopolamine patch and acupressure point P6 stimulation, as described above. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Female subjects ages 18 to 45
- Subjects with ASA Class I or II
- Subjects with elective primary or repeat cesarean delivery
- Subjects who receive spinal and/or epidural anesthesia
- English and non-English speaking subjects will be included in the study
Key exclusion criteria (11 listed)
- Female subjects <18 years of age
- Subjects requiring emergent cesarean delivery
- Gestational age < 37 weeks
- History of placenta accreta
- Multiple gestation 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 |
|---|---|---|
| scopolamine patchAlso: Transderm-Scop, Scopace, MaldemarGroup I (n=80): Will receive scopolamine patch placement on the skin behind the right ear 1 hour before initiation of the regional anesthesia for the duration of surgery. The time of the application of the patch will be recorded, and the time of the start of the surgery will be recorded. The last time point for evaluation of patient's nausea/vomiting will be when the patient arrives to the post anesthesia care unit. A member of the research team will remove the patch from the patient and properly dispose the patch upon arrival to the post anesthesia care unit. | Drug | scopolamine patch, scopolamine patch + acupressure point P6 |
| acupressure point P6Group II (n=80): Will receive acupressure point P6 stimulation. This is a stimulation of the chi channel at the master of the heart (MH8 position) at the small depression of the volar surface of the distal right forearm just above the crest of the wrist. The device will be put on the patients in the operating room prior to administration of the regional anesthesia and will be removed after the cesarean section is complete. The device will be removed from the patient in the operating room, before the patient is transported to the recovery room. Patients will receive continuous stimulation at a level that is comfortable for her prior to administration of the standardized regional anesthesia. | Device | acupressure point P6, scopolamine patch + acupressure point P6 |
Primary outcome
Number of Patients With Nausea
Time frame: Throughout the entire surgical procedure
The investigators will analyze if there is a statistically significant difference between the number of patients that experience nausea at any point during the surgical procedure in each group.
Number of Patients With Vomiting
Time frame: Throughout the surgical procedure
The investigators will perform objective assessments of whether or not the patients have vomited during the procedure. The investigators will then analyze if there is a statistically significant difference between the number of patients that vomit in each group.
9 secondary outcomes
Satisfaction With Intraoperative Antiemetic Treatment
Time frame: Throughout the surgical procedure
Level of Nausea After the Administration of the Regional Anesthesia Medications
Time frame: From administration of anaesthesia until eversion of uterus
Level of Nausea After Eversion of the Uterus
Time frame: After eversion of the uterus until replacement of the uterus
Level of Nausea After Replacement of the Uterus
Time frame: After replacement of the uterus and to the next 15 minutes
Level of Nausea Upon Arrival to the Post-operative Recovery Room
Time frame: 15 minutes after replacement of the uterus to arrival at post-anaesthesia care unit
Number of Patients With Vomiting After the Administration of the Regional Anesthesia Medications
Time frame: After the administration of the regional anesthesia medications until eversion of the uterus
Number of Patients With Vomiting After Eversion of the Uterus
Time frame: After eversion of to replacement of the uterus
Number of Patients With Vomiting After Replacement of the Uterus
Time frame: After replacement of the uterus and for next 15 minutes
Number of Patients With Vomiting Upon Arrival to the Post-operative Recovery Room
Time frame: From 15 minutes after replacement of the uterus until arrival at the post-anaesthesia care unit
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Dec 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 9054245Hawkins JL, Koonin LM, Palmer SK, Gibbs CP. Anesthesia-related deaths during obstetric delivery in the United States, 1979-1990. Anesthesiology. 1997 Feb;86(2):277-84. doi: 10.1097/00000542-199702000-00002.
- Background: PubMed 11590314Ezri T, Szmuk P, Evron S, Geva D, Hagay Z, Katz J. Difficult airway in obstetric anesthesia: a review. Obstet Gynecol Surv. 2001 Oct;56(10):631-41. doi: 10.1097/00006254-200110000-00022.
- Background: PubMed 20391961Malvasi A, Tinelli A, Stark M, Pontrelli G, Brizzi A, Wetzl RG, Benhamou D. Low-dose sequential combined spinal-epidural anaesthesia in elective Stark caesarean section: a preliminary cohort study. Eur Rev Med Pharmacol Sci. 2010 Mar;14(3):215-21.
- Background: PubMed 23076903Afolabi BB, Lesi FE. Regional versus general anaesthesia for caesarean section. Cochrane Database Syst Rev. 2012 Oct 17;10(10):CD004350. doi: 10.1002/14651858.CD004350.pub3.
- Background: PubMed 7893022Riley ET, Cohen SE, Macario A, Desai JB, Ratner EF. Spinal versus epidural anesthesia for cesarean section: a comparison of time efficiency, costs, charges, and complications. Anesth Analg. 1995 Apr;80(4):709-12. doi: 10.1097/00000539-199504000-00010.
- Background: PubMed 15935649Balki M, Carvalho JC. Intraoperative nausea and vomiting during cesarean section under regional anesthesia. Int J Obstet Anesth. 2005 Jul;14(3):230-41. doi: 10.1016/j.ijoa.2004.12.004.
- Background: PubMed 24497372Paranjothy S, Griffiths JD, Broughton HK, Gyte GM, Brown HC, Thomas J. Interventions at caesarean section for reducing the risk of aspiration pneumonitis. Cochrane Database Syst Rev. 2014 Feb 5;2014(2):CD004943. doi: 10.1002/14651858.CD004943.pub4.
- Background: PubMed 25822385Flake ZA, Linn BS, Hornecker JR. Practical selection of antiemetics in the ambulatory setting. Am Fam Physician. 2015 Mar 1;91(5):293-6.
- Background: PubMed 15947124Golembiewski J, Chernin E, Chopra T. Prevention and treatment of postoperative nausea and vomiting. Am J Health Syst Pharm. 2005 Jun 15;62(12):1247-60; quiz 1261-2. doi: 10.1093/ajhp/62.12.1247.
- Background: PubMed 21118734Apfel CC, Zhang K, George E, Shi S, Jalota L, Hornuss C, Fero KE, Heidrich F, Pergolizzi JV, Cakmakkaya OS, Kranke P. Transdermal scopolamine for the prevention of postoperative nausea and vomiting: a systematic review and meta-analysis. Clin Ther. 2010 Nov;32(12):1987-2002. doi: 10.1016/j.clinthera.2010.11.014.
- Background: PubMed 16175141Renner UD, Oertel R, Kirch W. Pharmacokinetics and pharmacodynamics in clinical use of scopolamine. Ther Drug Monit. 2005 Oct;27(5):655-65. doi: 10.1097/01.ftd.0000168293.48226.57.
- Background: PubMed 19370583Lee A, Fan LT. Stimulation of the wrist acupuncture point P6 for preventing postoperative nausea and vomiting. Cochrane Database Syst Rev. 2009 Apr 15;(2):CD003281. doi: 10.1002/14651858.CD003281.pub3.
- Individual participant dataSharing planned: No
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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.
Shaul Cohen, MD principal investigator
Robert Wood Johnson University Hospital
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 scopolamine patch and acupressure point P6 in people with Nausea and Vomiting, run by Rutgers, The State University of New Jersey 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 11 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 28 Dec 2022. 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. 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 28 Dec 2022). 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 Patients With Nausea (time frame: Throughout the entire surgical procedure). 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 NCT02960113, which also lists 16 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 28 Dec 2022.