Ignite Creation Date:
2024-05-06 @ 9:22 AM
Last Modification Date:
2024-10-26 @ 12:13 PM
Study NCT ID:
NCT02968082
Status:
UNKNOWN
Last Update Posted:
2016-11-18
First Post:
2016-10-19
Brief Title:
The Effects of Preoperative Scopolamine Patch Application on the Postoperative Nausea and Vomiting in MVD Surgery
Sponsor:
Seoul National University Hospital
Organization:
Seoul National University Hospital
Study Overview
Official Title:
The Effects of Preoperative Scopolamine Patch Application on the Postoperative Nausea and Vomiting in Microvascular Decompression Surgery
Status:
UNKNOWN
Status Verified Date:
2016-11
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 pm 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 10mg2ml 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 03mg 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 Fishers 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 Students t-test
3-4 Number of vomiting and antiemetic administration between experimental group and control group will be analyzed by Fishers exact test
3-5 Hospitalization period between experimental group and control group will be analyzed by Students 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
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 pm 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 10mg2ml 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 03mg 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 Fishers 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 Students t-test
3-4 Number of vomiting and antiemetic administration between experimental group and control group will be analyzed by Fishers exact test
3-5 Hospitalization period between experimental group and control group will be analyzed by Students 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None