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

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ClinicalTrials.gov Identifier: NCT02968082
Recruitment Status : Not yet recruiting
First Posted : November 18, 2016
Last Update Posted : November 18, 2016
Sponsor:
Information provided by (Responsible Party):
Jung Ho Han, Seoul National University Hospital

Brief 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

Condition or disease Intervention/treatment Phase
Patients Drug: Scopolamine Drug: Placebo Phase 4

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: The Effects of Preoperative Scopolamine Patch Application on the Postoperative Nausea and Vomiting in Microvascular Decompression Surgery
Study Start Date : November 2016
Estimated Primary Completion Date : October 2017
Estimated Study Completion Date : October 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Placebo group (P group)

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.

Drug: Placebo
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.

Experimental: Scopolamine group (S group)

'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.

Drug: Scopolamine
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.




Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02968082


Contacts
Contact: Jung Ho Han, PhD +82-31-787-7172 nstaus29@snubh.org
Contact: Eun-Jin Choi +82-31-787-7165 r0415@snubh.org

Sponsors and Collaborators
Seoul National University Hospital
Investigators
Principal Investigator: Jung Ho Han, PhD Seoul National University Bundang Hospital

Publications:
Responsible Party: Jung Ho Han, Associate Professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT02968082     History of Changes
Other Study ID Numbers: MVD
First Posted: November 18, 2016    Key Record Dates
Last Update Posted: November 18, 2016
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Jung Ho Han, Seoul National University Hospital:
MVD
Scopolamine
Microvascular Decompression

Additional relevant MeSH terms:
Vomiting
Postoperative Nausea and Vomiting
Signs and Symptoms, Digestive
Signs and Symptoms
Postoperative Complications
Pathologic Processes
Nausea
Scopolamine Hydrobromide
Butylscopolammonium Bromide
Adjuvants, Anesthesia
Mydriatics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Muscarinic Antagonists
Parasympatholytics