NCT02101671

Brief 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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
140

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2014

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

March 29, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 2, 2014

Completed
29 days until next milestone

Study Start

First participant enrolled

May 1, 2014

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

April 2, 2014

Status Verified

March 1, 2014

Enrollment Period

3 months

First QC Date

March 29, 2014

Last Update Submit

March 29, 2014

Conditions

Delayed Emergence From AnesthesiaDelirium, Cause UnknownConfusionDisorientation on Emergence

Keywords

agitationanaesthesialaparoscopysurgerydeliriumsedationemergencesteeptrendelemburgpositiondelayedConfusionDisorientation

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

trendelemburg positioning

Patients undergone laparoscopic surgery in trendelemburg position

Not trendelemburg positioning

Patients undergone laparoscopic surgery not in trendelemburg position

Eligibility Criteria

Age15 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patient undergone surgery

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Anaesthesia and Reanimation Department, Hospital Parc Tauli

Sabadell, Barcelona, 08208, Spain

Location

MeSH Terms

Conditions

Delayed Emergence from AnesthesiaDeliriumConfusionPsychomotor Agitation

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsNeurocognitive DisordersMental DisordersDyskinesiasPsychomotor DisordersAberrant Motor Behavior in DementiaBehavioral SymptomsBehavior

Study Officials

  • Morena Basso

    Corporacion Parc Tauli

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Morena Basso

CONTACT

00937231010morena.basso@gmail.com

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

March 29, 2014

First Posted

April 2, 2014

Study Start

May 1, 2014

Primary Completion

August 1, 2014

Study Completion

December 1, 2014

Last Updated

April 2, 2014

Record last verified: 2014-03

Locations

ES(1)