Recovery After Laparoscopic Surgery

NCT ID: NCT01992640

Last Updated: 2014-06-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

25 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-12-31

Study Completion Date

2014-05-31

Brief Summary

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During laparoscopic surgery, muscle relaxants are often administrated in order to ensure acceptable surgical conditions. These drugs bind to receptors in the neuromuscular junction.

The degree of muscle relaxation is monitored by use of an acceleromyography and at the end of surgery another drug - Neostigmine- is given to reverse the muscle relaxation. However,there may still be a blockade of up to 70% of the receptors.

This partial muscle relaxation may result in muscle weakness, reduced balance and prolonged hospitalization.

This study will describe changes in balance and subjective muscle weakness after laparoscopic surgery.

The primary hypothesis is that sway area is increased 30 min after extubation compared to the preoperative value.

Detailed Description

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Conditions

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Laparoscopy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Age above 18 years
* Same-day gynaecological laparoscopic surgery
* Informed consent

Exclusion Criteria

* Body mass index above 30 kg/m2
* Insufficient renal function
* Liver insufficience
* Neuromuscular monitoring not possible
* Known allergy towards medicine used in the protocol
* Daily use of opioids
* Known disease which can interfere with the balance
* Pregnant/lactating
* Cannot read or understand danish
* Fast-track intubation with use of succinylcholine
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Herlev Hospital

OTHER

Sponsor Role lead

Responsible Party

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Anne Kathrine Staehr-Rye

M.D.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Anne K Staehr-Rye, M.D.

Role: PRINCIPAL_INVESTIGATOR

Dept. of Anesthesiology, Herlev Hospital

Mona R Gätke, M.D.; Ph.D.

Role: STUDY_CHAIR

Dept. of Anesthesiology, Herlev Hospital

Locations

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Dept. of Anesthesiology, University of Copenhagen, Herlev Hospital

Herlev, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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11-2013

Identifier Type: -

Identifier Source: org_study_id

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