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

November 16, 2016 updated by: Jung Ho Han, Seoul National University Hospital

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

  1. 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.

  2. 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

  3. 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.

  4. 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 Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
just immediate after arrival at a recovery room or the ward and 4hr, 8hr, 12hr, 16hr, 20hr, and 24hr after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Investigators

  • Principal Investigator: Jung Ho Han, PhD, Seoul National University Bundang Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2016

Primary Completion (Anticipated)

October 1, 2017

Study Completion (Anticipated)

October 1, 2017

Study Registration Dates

First Submitted

October 19, 2016

First Submitted That Met QC Criteria

November 16, 2016

First Posted (Estimate)

November 18, 2016

Study Record Updates

Last Update Posted (Estimate)

November 18, 2016

Last Update Submitted That Met QC Criteria

November 16, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MVD

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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