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

NCT02968082 | Unknown Phase 4 DMC

• 1 other identifier: MVD
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

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

Conditions

Patients

Keywords

MVD; Scopolamine; Microvascular Decompression

Outcome Measures

Primary Outcomes (1)

• 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.

  just immediate after arrival at a recovery room or the ward and 4hr, 8hr, 12hr, 16hr, 20hr, and 24hr after surgery

Study Arms (2)

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.

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.

Drug: Scopolamine

Interventions

Scopolamine DRUG

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.

Scopolamine group (S group)

Placebo DRUG

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.

Placebo group (P group)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Hospital: lead

Related Publications (4)

• 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.

  PMID: 23649917 BACKGROUND

• 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.

  PMID: 22608591 BACKGROUND

• 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.

  PMID: 18262140 BACKGROUND

• 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.

  PMID: 21118734 BACKGROUND

MeSH Terms

Interventions

Scopolamine

Intervention Hierarchy (Ancestors)

Scopolamine Derivatives; Tropanes; Azabicyclo Compounds; Aza Compounds; Organic Chemicals; Belladonna Alkaloids; Solanaceous Alkaloids; Alkaloids; Heterocyclic Compounds; Bridged Bicyclo Compounds, Heterocyclic; Heterocyclic Compounds, Bridged-Ring

Study Officials

• Jung Ho Han, PhD

  Seoul National University Bundang Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jung Ho Han, PhD

CONTACT

+82-31-787-7172; nstaus29@snubh.org

Eun-Jin Choi

CONTACT

+82-31-787-7165; r0415@snubh.org

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: October 19, 2016
• First Posted: November 18, 2016
• Study Start: November 1, 2016
• Primary Completion: October 1, 2017
• Study Completion: October 1, 2017
• Last Updated: November 18, 2016

Record last verified: 2016-11

Data Sharing

• IPD Sharing: Will not share