Inadequate Emergence After Laparoscopic Surgery in Trendelemburg Position

March 29, 2014 updated by: Morena Basso, Corporacion Parc Tauli

Inadequate Emergence After Anaesthesia in Laparoscopic Surgery in Trendelemburg Position

The purpose of this study is to determinate if the patients submitted to laparoscopic surgery in trendelemburg position develope more inadequate anaesthesic emergence than patients submitted to laparoscopic surgery in other positions.

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

140

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 Locations

  • Spain
    • Barcelona
      • Sabadell, Barcelona, Spain, 08208
        • Anaesthesia and Reanimation Department, Hospital Parc Tauli

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

15 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patient undergone surgery

Description

Inclusion Criteria:

  • laparoscopic surgery
  • general anaesthesia
  • trendelemburg positioning
  • extubated in the operatory theater

Exclusion Criteria:

  • unable of communicate
  • dementia
  • psychiatric history
  • neurosurgery
  • alchohol and drugs addictions

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

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
trendelemburg positioning
Patients undergone laparoscopic surgery in trendelemburg position
Not trendelemburg positioning
Patients undergone laparoscopic surgery not in trendelemburg position

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Inadequate emergence after anaesthesia
Time Frame: 10 minutes after the arrival of the patient in the postsurgical unit
The inadequate emergence after anaesthesia will be evalueted with the Richmond Agitation Sedation Scale, defining as inadequate emergence a punctuation >= +1 (delirium form) and <=-2 (hypoactive form).
10 minutes after the arrival of the patient in the postsurgical unit

Collaborators and Investigators

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

Sponsor

Corporacion Parc Tauli

Investigators

  • Principal Investigator: Morena Basso, Corporacion Parc Tauli

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

May 1, 2014

Primary Completion (Anticipated)

August 1, 2014

Study Completion (Anticipated)

December 1, 2014

Study Registration Dates

First Submitted

March 29, 2014

First Submitted That Met QC Criteria

March 29, 2014

First Posted (Estimate)

April 2, 2014

Study Record Updates

Last Update Posted (Estimate)

April 2, 2014

Last Update Submitted That Met QC Criteria

March 29, 2014

Last Verified

March 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2014/522

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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