NCT00452855

Brief Summary

The purpose of this study is to determine whether sevoflurane-remifentanil anaesthesia is similar to propofol-remifentanil anaesthesia concerning post- operative nausea and vomiting.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
160

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2002

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2002

Completed
3.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2005

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

March 26, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 28, 2007

Completed
Last Updated

March 29, 2007

Status Verified

March 1, 2007

First QC Date

March 26, 2007

Last Update Submit

March 28, 2007

Conditions

NauseaVomiting

Keywords

NauseaVomitingPost operativePropofol remifentanil anaesthesiaSevoflurane remifentanil anaesthesia

Outcome Measures

Primary Outcomes (3)

  • Nausea, incidence and intensity ( VAS score )in PACU and surgical ward

  • Vomiting, incidence in PACU and surgical ward

  • Total PONV after 24 hours

Interventions

Sevoflurane-remifentanil anaesthesiaPROCEDURE

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Females younger than 50 years
  • ASA I-II
  • Scheduled to gynaecological laparotomies or laparoscopies

You may not qualify if:

  • Medication known to act anti-emetic
  • ASA status greater than II
  • Malignant hyperthermia
  • Allergy to the drugs used.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Viborg Hospital

Viborg, 8800, Denmark

Location

MeSH Terms

Conditions

NauseaVomiting

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Jens Ole Dich JO Nielsen, MD

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 26, 2007

First Posted

March 28, 2007

Study Start

January 1, 2002

Study Completion

May 1, 2005

Last Updated

March 29, 2007

Record last verified: 2007-03

Locations

DK(1)