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NCT02101671 Clinical Trial

Inadequate Emergence After Laparoscopic Surgery in Trendelemburg Position

Confusion Clinical Trial

Official title:
Inadequate Emergence After Anaesthesia in Laparoscopic Surgery in Trendelemburg Position

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT02101671
Other study ID # 2014/522
Secondary ID
Status Not yet recruiting
Phase N/A
First received March 29, 2014
Last updated March 29, 2014
Start date May 2014
Est. completion date December 2014

Study information
Verified date March 2014
Source Corporacion Parc Tauli
Contact Morena Basso
Phone 00937231010
Email morena.basso@gmail.com
Is FDA regulated No
Health authority Spain: Ministry of Health
Study type Observational

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 140
Est. completion date December 2014
Est. primary completion date August 2014
Accepts healthy volunteers No
Gender Both
Age group 15 Years and older
Eligibility 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 Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
Spain Anaesthesia and Reanimation Department, Hospital Parc Tauli Sabadell Barcelona

Sponsors (1)
Lead Sponsor Collaborator
Corporacion Parc Tauli

Country where clinical trial is conducted

Spain, 

Outcome
Type Measure Description Time frame Safety issue
Primary Inadequate emergence after anaesthesia 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 No
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