PatientsPhase 4NCT02968082

The Effects of Preoperative Scopolamine Patch Application on the Postoperative Nausea and Vomiting in MVD Surgery

A Phase 4 study testing Scopolamine in people with Patients, run by Seoul National University Hospital.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Trial summary

A Single-center, randomized, prospective, experimental, double-blind comparison study for effects of preoperative scopolamine patch application on the postoperative nausea and vomiting in microvascular decompression surgery Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Patients
What is being tested?: Scopolamine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 60 participants
Where: No sites listed yet
Study dates: Nov 2016to Oct 2017
Phase: Phase 4
Are there results?: None posted in the registry

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 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Those of either hemi-facial spasm or trigeminal neuralgia, who undergo microvascular decompression (MVD), understand study objectives and voluntarily consent with participation.
Adequate communication ability enough to understand and answer the questionnaire.
Age ≥ 18 years, and ≤ 65 years.
ASA Physical Status Classification from 1 to 2. Class 1: A normal healthy patient Class 2: A patient with mild systemic disease
Those who is discharged to general ward, not intensive care unit (ICU) after operation
Normal liver or kidney function

Who cannot join

More than one craniotomy in the same period of admission
Pregnant or lactating women
Narrow-angle glaucoma
Pyloric stenosis, intestinal obstruction, bladder obstruction
Bradycardia
Voiding difficulty such as benign prostate hypertrophy (BPH)
Any history of hypersensitivity to ointment base or scopolamine patch

Trial locations and contacts

No sites are listed yet.

Jung Ho Han, PhD contact

Eun-Jin Choi contact

About this study

Official title: The Effects of Preoperative Scopolamine Patch Application on the Postoperative Nausea and Vomiting in Microvascular Decompression Surgery

Read the detailed description

Study design and plan 1-1) Sixty envelopes will be prepared: Thirty envelopes of scopolamine patch for experimental group and 30 of placebo patch for control group. Each envelope will be tagged for QR code, randomly mixed and numbered from 1 to 60. QR code will be identified after discontinuation of study, so both researchers and subjects would not know in which group the envelope is belonged to. 1-2) Patch will be applied under the ear of the opposite side of operation, at 9 p.m. of the day before the operation day. 1-3) Nausea will be assessed by Visual Analogue Scale (VAS) immediate after arrival at a recovery room and the ward. After that, nausea will be continuously assessed every 4 hour (4hr, 8hr, 12hr, 16hr, 20hr, and 24hr after surgery) and a number of vomiting will also be counted. Basic clinical characteristics and the number of antiemetic administration will be identified through medical records.
Efficacy assessment 2-1) Degree of nausea: Visual Analogue Scale (VAS) Subjects will describe their subject degree of nausea by VAS score, just immediate after arrival at a recovery room or the ward and 4hr, 8hr, 12hr, 16hr, 20hr, and 24hr after surgery. Respondents specify their degree of nausea by indicating a point along a continuous 10cm line between two end-points; left one is for "No nausea" and the right one for "Very severe nausea". Scoring is based on the length from left point and higher score means more severe degree of nausea. 2-2) Number of vomiting Number of vomiting is counted from immediate after arrival at recovery room or the ward, 4hr, 8hr, 12hr, 16hr, 20hr, and 24hr after operation and will be recorded. If there is no vomiting, it will be recorded as "0". 2-3) Number of antiemetic administration It will be recorded from immediate after arrival at recovery room or the ward, 4hr, 8hr, 12hr, 16hr, 20hr, and 24hr after operation. The kind of antiemetic used and the dosage or number of administration can be identified through medical records. 2-4) Type of antiemetic and time of administration 2-4-1) PRN) Meckool 10mg/2ml 1amp IVs When VAS is more than 5 or when subjects want at minimum interval of 6hour and maximum of three times. If there is no improvement, it will be noticed. 2-4-2) PRC) Nasea 0.3mg 1amp IVs
Statistical plans 3-1) General characteristics and clinical characteristics will be analyzed by frequency, percentage, mean value and standard deviation. 3-2) Homogeneity of variances between experimental group and control group will be analyzed by Chi-square test, t-test and Fisher's exact test 3-3) Degree of nausea between experimental group and control group at recovery room or the ward, 4hr, 8hr, 12hr, 16hr, 20hr, and 24hr after operation will be analyzed by Student's t-test. 3-4) Number of vomiting and antiemetic administration between experimental group and control group will be analyzed by Fisher's exact test. 3-5) Hospitalization period between experimental group and control group will be analyzed by Student's t-test.
Experimental group of scopolamine patch application will be expected to have less severity of nausea and fewer numbers of vomiting or antiemetic usages. Ultimately, this may relate to hospitalization period and it will be decreased.

Conditions: Patients
Being tested: Scopolamine, Placebo
Keywords: MVD, Scopolamine, Microvascular Decompression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ScopolamineDrug
Patch will be applied under the ear of the opposite side of operation, at 9 p.m. of the day before the operation day. Nausea will be assessed by Visual Analogue Scale (VAS) immediate after arrival at a recovery room and the ward. After that, nausea will be continuously assessed every 4 hour (4hr, 8hr, 12hr, 16hr, 20hr, and 24hr after surgery) and a number of vomiting will also be counted. Basic clinical characteristics and the number of antiemetic administration will be identified through medical records.
PlaceboDrug
Patch will be applied under the ear of the opposite side of operation, at 9 p.m. of the day before the operation day. Nausea will be assessed by Visual Analogue Scale (VAS) immediate after arrival at a recovery room and the ward. After that, nausea will be continuously assessed every 4 hour (4hr, 8hr, 12hr, 16hr, 20hr, and 24hr after surgery) and a number of vomiting will also be counted. Basic clinical characteristics and the number of antiemetic administration will be identified through medical records.

Study groups in NCT02968082
Study group	Role	What they receive
Placebo group (P group)	Placebo comparator	The group that not existed scopolamine ingredient. dosage form: apply dosage: 1.5 mg frequency: 1 times (at 9 p.m. of the day before the operation day) duration: Until the 24hr after operation. Patients will be applied patch that not existed scopolamine ingredient. Receives: Drug: Placebo
Scopolamine group (S group)	Experimental	'Scopolamine (1.5mg) 1 patch' The group that existed scopolamine ingredient dosage form: apply dosage: 1.5 mg frequency: 1 times (at 9 p.m. of the day before the operation day) duration: Until the 24hr after operation. Patients will be applied patch that existed scopolamine ingredient. Receives: Drug: Scopolamine

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Degree of nausea: Visual Analogue Scale (VAS)
Subjects will describe their subject degree of nausea by VAS score, just immediate after arrival at a recovery room or the ward and 4hr, 8hr, 12hr, 16hr, 20hr, and 24hr after surgery. Respondents specify their degree of nausea by indicating a point along a continuous 10cm line between two end-points; left one is for "No nausea" and the right one for "Very severe nausea". Scoring is based on the length from left point and higher score means more severe degree of nausea.
Measured: just immediate after arrival at a recovery room or the ward and 4hr, 8hr, 12hr, 16hr, 20hr, and 24hr after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 2016Oct 2017

First posted18 Nov 2016 (estimated)
Study startNov 2016
Primary completionOct 2017 (estimated)
Study completionOct 2017 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (4)Papers the sponsor has linked to this study.
Other trials for PatientsStudies of the same condition, open and under way.
More trials run by Seoul National University HospitalThe 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: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 60 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02968082
Sponsor's protocol ID: MVD
Status last verified: Nov 2016
First submitted: 19 Oct 2016
Last updated: 18 Nov 2016
Results posted: No
Data monitoring committee: Yes
Individual data sharing: No

Publications

Sato K, Sai S, Adachi T. Is microvascular decompression surgery a high risk for postoperative nausea and vomiting in patients undergoing craniotomy? J Anesth. 2013 Oct;27(5):725-30. doi: 10.1007/s00540-013-1621-9. Epub 2013 May 7.
PubMed 23649917
Pergolizzi JV Jr, Philip BK, Leslie JB, Taylor R Jr, Raffa RB. Perspectives on transdermal scopolamine for the treatment of postoperative nausea and vomiting. J Clin Anesth. 2012 Jun;24(4):334-45. doi: 10.1016/j.jclinane.2011.07.019.
PubMed 22608591
Einarsson JI, Audbergsson BO, Thorsteinsson A. Scopolamine for prevention of postoperative nausea in gynecologic laparoscopy, a randomized trial. J Minim Invasive Gynecol. 2008 Jan-Feb;15(1):26-31. doi: 10.1016/j.jmig.2007.08.616.
PubMed 18262140
Apfel 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 21118734

Want to know more?

Jung Ho Han, PhD

+82-31-787-7172

nstaus29@snubh.org

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 18 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Effects of Preoperative Scopolamine Patch Application on the Postoperative Nausea and Vomiting in Microvascular Decompression Surgery
ClinicalTrials.gov ID: NCT02968082
Acronym / sponsor ID: MVD
Conditions: Patients
Keywords: MVD, Scopolamine, Microvascular Decompression
Phase: Phase 4
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 60 participants (estimated)
Lead sponsor: Seoul National University HospitalUniversity, hospital or other
Study start: Nov 2016
Primary completion: Oct 2017 (estimated)
Study completion: Oct 2017 (estimated)
First posted: 18 Nov 2016 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design and plan 1-1) Sixty envelopes will be prepared: Thirty envelopes of scopolamine patch for experimental group and 30 of placebo patch for control group. Each envelope will be tagged for QR code, randomly mixed and numbered from 1 to 60. QR code will be identified after discontinuation of study, so both researchers and subjects would not know in which group the envelope is belonged to. 1-2) Patch will be applied under the ear of the opposite side of operation, at 9 p.m. of the day before the operation day. 1-3) Nausea will be assessed by Visual Analogue Scale (VAS) immediate after arrival at a recovery room and the ward. After that, nausea will be continuously assessed every 4 hour (4hr, 8hr, 12hr, 16hr, 20hr, and 24hr after surgery) and a number of vomiting will also be counted. Basic clinical characteristics and the number of antiemetic administration will be identified through medical records.
Efficacy assessment 2-1) Degree of nausea: Visual Analogue Scale (VAS) Subjects will describe their subject degree of nausea by VAS score, just immediate after arrival at a recovery room or the ward and 4hr, 8hr, 12hr, 16hr, 20hr, and 24hr after surgery. Respondents specify their degree of nausea by indicating a point along a continuous 10cm line between two end-points; left one is for "No nausea" and the right one for "Very severe nausea". Scoring is based on the length from left point and higher score means more severe degree of nausea. 2-2) Number of vomiting Number of vomiting is counted from immediate after arrival at recovery room or the ward, 4hr, 8hr, 12hr, 16hr, 20hr, and 24hr after operation and will be recorded. If there is no vomiting, it will be recorded as "0". 2-3) Number of antiemetic administration It will be recorded from immediate after arrival at recovery room or the ward, 4hr, 8hr, 12hr, 16hr, 20hr, and 24hr after operation. The kind of antiemetic used and the dosage or number of administration can be identified through medical records. 2-4) Type of antiemetic and time of administration 2-4-1) PRN) Meckool 10mg/2ml 1amp IVs When VAS is more than 5 or when subjects want at minimum interval of 6hour and maximum of three times. If there is no improvement, it will be noticed. 2-4-2) PRC) Nasea 0.3mg 1amp IVs
Statistical plans 3-1) General characteristics and clinical characteristics will be analyzed by frequency, percentage, mean value and standard deviation. 3-2) Homogeneity of variances between experimental group and control group will be analyzed by Chi-square test, t-test and Fisher's exact test 3-3) Degree of nausea between experimental group and control group at recovery room or the ward, 4hr, 8hr, 12hr, 16hr, 20hr, and 24hr after operation will be analyzed by Student's t-test. 3-4) Number of vomiting and antiemetic administration between experimental group and control group will be analyzed by Fisher's exact test. 3-5) Hospitalization period between experimental group and control group will be analyzed by Student's t-test.
Experimental group of scopolamine patch application will be expected to have less severity of nausea and fewer numbers of vomiting or antiemetic usages. Ultimately, this may relate to hospitalization period and it will be decreased.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
Placebo group (P group)	Placebo comparator	Drug: PlaceboThe group that not existed scopolamine ingredient. dosage form: apply dosage: 1.5 mg frequency: 1 times (at 9 p.m. of the day before the operation day) duration: Until the 24hr after operation. Patients will be applied patch that not existed scopolamine ingredient.
Scopolamine group (S group)	Experimental	Drug: Scopolamine'Scopolamine (1.5mg) 1 patch' The group that existed scopolamine ingredient dosage form: apply dosage: 1.5 mg frequency: 1 times (at 9 p.m. of the day before the operation day) duration: Until the 24hr after operation. Patients will be applied patch that existed scopolamine ingredient.

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Those of either hemi-facial spasm or trigeminal neuralgia, who undergo microvascular decompression (MVD), understand study objectives and voluntarily consent with participation.
Adequate communication ability enough to understand and answer the questionnaire.
Age ≥ 18 years, and ≤ 65 years.
ASA Physical Status Classification from 1 to 2. Class 1: A normal healthy patient Class 2: A patient with mild systemic disease
Those who is discharged to general ward, not intensive care unit (ICU) after operation

Key exclusion criteria (7 listed)

More than one craniotomy in the same period of admission
Pregnant or lactating women
Narrow-angle glaucoma
Pyloric stenosis, intestinal obstruction, bladder obstruction
Bradycardia

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
ScopolaminePatch will be applied under the ear of the opposite side of operation, at 9 p.m. of the day before the operation day. Nausea will be assessed by Visual Analogue Scale (VAS) immediate after arrival at a recovery room and the ward. After that, nausea will be continuously assessed every 4 hour (4hr, 8hr, 12hr, 16hr, 20hr, and 24hr after surgery) and a number of vomiting will also be counted. Basic clinical characteristics and the number of antiemetic administration will be identified through medical records.	Drug	Scopolamine group (S group)
PlaceboPatch will be applied under the ear of the opposite side of operation, at 9 p.m. of the day before the operation day. Nausea will be assessed by Visual Analogue Scale (VAS) immediate after arrival at a recovery room and the ward. After that, nausea will be continuously assessed every 4 hour (4hr, 8hr, 12hr, 16hr, 20hr, and 24hr after surgery) and a number of vomiting will also be counted. Basic clinical characteristics and the number of antiemetic administration will be identified through medical records.	Drug	Placebo group (P group)

Primary outcome

Change in Degree of nausea: Visual Analogue Scale (VAS)
Time frame: just immediate after arrival at a recovery room or the ward and 4hr, 8hr, 12hr, 16hr, 20hr, and 24hr after surgery
Subjects will describe their subject degree of nausea by VAS score, just immediate after arrival at a recovery room or the ward and 4hr, 8hr, 12hr, 16hr, 20hr, and 24hr after surgery. Respondents specify their degree of nausea by indicating a point along a continuous 10cm line between two end-points; left one is for "No nausea" and the right one for "Very severe nausea". Scoring is based on the length from left point and higher score means more severe degree of nausea.

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2016.
Background: PubMed 23649917Sato K, Sai S, Adachi T. Is microvascular decompression surgery a high risk for postoperative nausea and vomiting in patients undergoing craniotomy? J Anesth. 2013 Oct;27(5):725-30. doi: 10.1007/s00540-013-1621-9. Epub 2013 May 7.
Background: PubMed 22608591Pergolizzi JV Jr, Philip BK, Leslie JB, Taylor R Jr, Raffa RB. Perspectives on transdermal scopolamine for the treatment of postoperative nausea and vomiting. J Clin Anesth. 2012 Jun;24(4):334-45. doi: 10.1016/j.jclinane.2011.07.019.
Background: PubMed 18262140Einarsson JI, Audbergsson BO, Thorsteinsson A. Scopolamine for prevention of postoperative nausea in gynecologic laparoscopy, a randomized trial. J Minim Invasive Gynecol. 2008 Jan-Feb;15(1):26-31. doi: 10.1016/j.jmig.2007.08.616.
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.
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.

Jung Ho Han, PhD contact

Eun-Jin Choi contact

Jung Ho Han, PhD principal investigator

Seoul National University Bundang Hospital

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Scopolamine in people with Patients, run by Seoul National University Hospital.

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 6 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: status not confirmed, as of the sponsor's last update on 18 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.

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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Jung Ho Han, PhD (+82-31-787-7172, nstaus29@snubh.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Degree of nausea: Visual Analogue Scale (VAS) (time frame: just immediate after arrival at a recovery room or the ward and 4hr, 8hr, 12hr, 16hr, 20hr, and 24hr 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 NCT02968082, 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 18 Nov 2016; AzTrials last refreshed its copy on 26 Oct 2026.