Prospective randomized double blind trial on the use of Scopoderm patch for control of post-operative nausea and vomitting in patients undergoing gynecologic laparoscopic procedures.

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2005-005928-13-IS

Enrollment

Registered

2006-01-18

Start date

Unknown

Completion date

Unknown

Last updated

2024-11-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Post-operative nausea and vomiting in patients undergoing gynecologic laparoscopic procedures.

Interventions

Trade Name: Scopoderm Product Name: Scopoderm Pharmaceutical Form: Transdermal patch Pharmaceutical form of the placebo: Transdermal patch Route of administration of the placebo: Cutaneous use

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients scheduled to undergo gynecologic laparoscopic surgery at Landspitali University Hospital will be offered to participate. In order to detect a 25% difference in nausea between tha two groups we project that we will need to enroll 24 patients in each group for a total of 48 patients. This is assuming an alpha of 0.05 and a beta of 0.20. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Nursing and pregnant women, allergy to substances in the patch, narrow angle glaucoma.

Design outcomes

Primary

Measure	Time frame
Main Objective: The Main Objective is to determine whether the use of a scopolamine patch has significant effect to reduce post-operative nausea and vomiting in patients undergoing gynecologic laparoscopic procedures. ;Secondary Objective: ;Primary end point(s): The night before surgery a patch will be attached. Following informed consent procedures, patients will be randomized into two groups. One group will receive a scopolamine patch but the other group will reiceive a patch without an active ingredient. The patients will keep the patch on for 72 hours. We will collect information on post-operative nausea and vomiting by a visual analog scale for three days following surgery. Additionally, use of antiemetic medications and pain medications will be recorded as well as the number of emetic episodes. The primary endpoint will be the difference of the level of nausea on post-operative day 1	—

Measure

Time frame

Main Objective: The Main Objective is to determine whether the use of a scopolamine patch has significant effect to reduce post-operative nausea and vomiting in patients undergoing gynecologic laparoscopic procedures. ;Secondary Objective: ;Primary end point(s): The night before surgery a patch will be attached. Following informed consent procedures, patients will be randomized into two groups. One group will receive a scopolamine patch but the other group will reiceive a patch without an active ingredient. The patients will keep the patch on for 72 hours. We will collect information on post-operative nausea and vomiting by a visual analog scale for three days following surgery. Additionally, use of antiemetic medications and pain medications will be recorded as well as the number of emetic episodes. The primary endpoint will be the difference of the level of nausea on post-operative day 1

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Countries

Iceland

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026